Amgen

Lets do this. Lets change the world. In this vital role, you will be responsible for digital/tech market sensing/prospecting and will help drive strategic opportunities in the digital health/data and analytics space. Amgen is seeking a Business Development Manager to join the Digital Health & Innovation (DH&I) organization. The Manager will report to the Director, Technology, Strategy & Innovation BD Lead. The Business Development Manager will be responsible for maintaining visibility into the digital/technology ecosystem and will serve as the lead in the development and delivery of market sensing/competitive intelligence and prospecting efforts in the digital health/technology space. The Incumbent will also be responsible for driving the teams internal and external engagement strategies. Expected tangible results from the Manager include establishing strategic relationships by executing collaborative agreements in partnership with Amgens legal and Compliance groups and managing established relationships. The Manager may also be involved in engaging with external corporate entities to source, evaluate and negotiate agreements to access innovative technologies in support of Amgens overall Digital Health & Innovation strategy. Key responsibilities of the Business Development Manager include: Maintain visibility into the digital health ecosystem and the landscape of digital technology, to inform DH&I strategy development and engagement planning and to identify key trends and opportunities to shape enterprise digital strategy Lead in the development and delivery of tech Competitive Intelligence Reports- ensuring DH&I and stakeholders are kept abreast of key technology headlines/news and its impact to the business and healthcare ecosystem at large Build and maintains positive working relationships with key internal and external stakeholders, including cross functional Amgen teams as well as digital health ecosystem to understand their needs Consult with relevant internal stakeholders to gather customer insights and needs Create internal & external understanding around DH&I projects through succinct summaries and published pieces Lead execution of cross-functional strategies in consultation with key stakeholders Drive successful and timely completion of cross-functional deliverables Drive effective decision making within the team, including communication of decisions to appropriate stakeholders Basic Qualifications: Doctorate degree OR Masters degree and 2 years of Healthcare Technology experience OR Bachelors degree and 4 years of Healthcare Technology experience OR Associates degree and 10 years of Healthcare Technology experience OR High school diploma / GED and 12 years of Healthcare Technology experience Preferred Qualifications: 4+ years of experience in biotech/pharma/technology business development and/or drug development Experience in working at or with Digital Start ups and/or Digital Health technology companies with experience in a BD or partnership, consulting or deal-making role A passion for digital health and technology with the ability to identify and hone in on opportunities that will drive business impact Ability to work in a matrix organization McKinsey/Bain or BCG consulting experience if applicable in areas of Digital Delivery Experience with relationship management and executive level advisory role(s) Biotech or Pharma experience in an integrated technology environment Excellent verbal, written, and interpersonal communication skills, including the ability to set the context and present on complex subjects to senior management in a clear and concise manner High ability to deal with complexity and ambiguity, ability to see the big picture, ability to collect, digest and assemble information to enable relevant business analyses and facilitate decision-making Experience with Venture Capital Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

ASSOCIATE SOFTWARE ENGINEER Would you like to take your full stack engineering skills and help deliver the world's most advanced and life-changing biotech medicines by building creative and groundbreaking software frameworks? We are seeking a Associate Software Engineer in Amgen's Global Commercial IS team, supporting the US Coverage and Pricing business organization. This position is responsible for designing and building secure, compliant, scalable solutions for the US Contracts and Pricing product working with other Platform/Product Owners, Architects, and within the broader technology team to develop products aligned with best practices. The Contracts and Pricing product team provides platforms and technologies for contract operations which includes processing transactions from pharmaceutical wholesalers, payment of discounts and fees to payers and providers, and government price reporting. The role will be responsible for delivering the backlog of product capabilities, roadmap planning, develop and adopt best practices, and optimize engineering for CI/CD in a Dev/Ops environment. The Associate Software Engineer must have an excellent understanding of computer science and a demonstrated willingness to learn and apply new technology. The candidate must processes superior technical aptitude, intellectual curiosity, written and oral communications skills, and the ability to deal effectively with people in a wide variety of situations. Additionally, the candidate must possess strong analytical skills with demonstrated problem solving ability. Previous experience exercising high levels of initiative, judgment, and diplomacy preferred. Proven ability to operate in high pressure situations, successfully handle multiple priorities, and possess a high level of discipline while remaining flexible. Job Responsibilities: With guidance, applies knowledge of basic principles, methods and practices to simple and moderately complex assignments as follows: Capture, negotiate, decompose and derive user stories for backlog grooming and agile ceremonies. Work with team members on elements of the pipeline and add, refactor, and improve capabilities across our architecture and our continuous CI/CD pipeline. Participate in efforts to design, build, and develop solutions and services. Help develop, test, deploy, and operate the service. Create automated test scripts leveraging Selenium/UFT to use across the system. Work with platform expertise to understand the system data model, configurations, architectures, to design and build for merge & acquisition data conversion and validation packages. Develop and maintain shared code libraries and facilitate training and adoption by other developers from other IS organizations while finding opportunities for reusability Participate in Agile meetings to contribute with development strategies and product roadmap Basic Qualifications Bachelors degree OR Associates degree with 4 years of Programming or Computational Science experience OR High School Diploma/GED with 6 years of Programming or Computational Science experience Preferred Qualifications Bachelors degree in Computer science or IT related field. Understanding of agile methodology & DevOps (Jenkins, Docker, JIRA, Gitlab) frameworks Familiar with data analysis and reporting experience by using analytics, visualization and database technologies (Oracle, PL SQL, Spotfire, Tableau, Python NumPy, SciPy, Pandas) Knowledge of pharmaceutical revenue management system is a strong plus. Strong written and oral communication skills and technical expertise to be able to communicate effectively with business and technology partners. Experience in Software Engineering and Development Experience in Cloud platforms (AWS, Databricks) Experience in developing and supporting web applications including familiarity with web technologies and frameworks (EXTJS, D3 JS, React.js) Experience in relational database fundamentals, and software quality methodology Knowledge of or experience in Life, Physical or Computational Sciences Strong written and oral communication skills Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do. We equip all our staff members to live well-rounded, healthy lives. Amgen provides benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions. Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new sciences promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve peoples lives. Job Summary The Corporate Audit Manager will report to the Corporate Audit Director for Healthcare Compliance Audit. The Audit Manager will assist the Chief Audit Executive, Directors, Senior Managers and Staff of Amgen Corporate Audit in providing independent, objective assurance and consulting services. The Audit Manager will also help determine whether the Company's systems of risk management, control and governance processes are adequate and functioning in a manner appropriate to a company of Amgens size and market. Responsibilities of the Corporate Audit Manager include: Effectively plans, coordinates, and conducts periodic audits of healthcare compliance business processes in accordance with approved annual audit plans Interacts with Amgen senior and mid-level management Demonstrates a high level of professionalism and the ability to manage multiple projects simultaneously Successfully manages and cultivates key relationships to ensure that Corporate Audit's scope of work and the objectives of the organization are completed in a cost-effective and timely manner Exercises excellent judgment and initiative in handling business issues of significance to Corporate Audit and the Company Effectively researches the laws, codes and regulations applicable to the healthcare compliance risks Drafts work papers documenting work performed and written communications of audit and consulting engagement results Provides project management responsibility for leading the direction and accomplishments of overall goals and objectives of audits Discharges responsibilities in a manner that is consistent with The Institute of Internal Auditors' Code of Ethics, International Standards for the Professional Practice of Internal Auditing and Statement of Responsibilities, as well as the Association of Healthcare Compliance Internal Auditors Seven Component Framework Travel up to 15% per year Basic Qualifications: Masters degree OR Bachelors degree and 4 years of Audit experience OR Associates degree and 7 years of Audit experience OR High school diploma / GED and 8 years of Audit experience Preferred Qualifications Big 4 and Fortune 500 internal audit experience Advanced certification (i.e., MBA, CPA, CISA or Six Sigma) Knowledge and understanding of internal control framework Knowledge and understanding of healthcare compliance risks Pharmaceutical / biotechnology industry experience Self-starter with excellent project management skills Analytical, interpersonal, team-building, leadership and conflict resolution skills Excellent business acumen (e.g. knowledge of business drivers, finding solutions, and knowledge of accounting, finance and other business areas) Strong communication skills (both verbal and written), including the ability to effectively and confidentially interact with Amgen senior management Proficient in Microsoft Word, Excel, Power Point, Visio, as well as Tableau, Alteryx, Smartsheets Relevant auditing or compliance professional certifications: Certified Internal Auditor (CIA), Certified Public Accountant (CPA), Chartered Accountant, Certified Compliance and Ethics Professional (CCEP), and/or Certified Fraud Examiner (CFE) Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Lets do this. Lets change the world. In this vital role, you will be responsible for digital/tech market sensing/prospecting and will help drive strategic opportunities in the digital health/data and analytics space. Amgen is seeking a Business Development Senior Associate to join the Digital Health & Innovation (DH&I) organization. The Senior Associate will report to the Manager, Digital Health & Innovation. The Business Development Senior Associate will be responsible for maintaining visibility into the digital/technology ecosystem and will support in the development and delivery of competitive intelligence efforts in the digital health/technology space. The Incumbent will also be responsible for supporting the teams internal and external engagement strategies. Expected tangible results from the Senior Associate include establishing strategic relationships by executing collaborative agreements in partnership with Amgens legal and Compliance groups and managing established relationships. The Senior Associate may also be involved in engaging with external corporate entities to source, evaluate and negotiate agreements to access innovative technologies in support of Amgens overall Digital Health & Innovation strategy. Key responsibilities of the Business Development Senior Associate include: Maintain visibility into the digital health ecosystem and the landscape of digital technology, to inform DH&I strategy development and engagement planning and to identify key trends and opportunities to shape enterprise digital strategy Support in the development and delivery of tech Competitive Intelligence Reports- ensuring DH&I and stakeholders are kept abreast of key technology headlines/news and its impact to the business and healthcare ecosystem at large Support the build and maintenance of positive working relationships with key internal and external stakeholders, including cross functional Amgen teams as well as digital health ecosystem to understand their needs Create internal & external understanding around DH&I projects through succinct summaries and published pieces Drive successful and timely completion of cross-functional deliverables Basic Qualifications: Masters degree OR Bachelors degree and 2 years of Healthcare Technology experience OR Associates degree and 6 years of Healthcare Technology experience OR High school diploma / GED and 8 years of Healthcare Technology experience Preferred Qualifications: 4+ years of experience in biotech/pharma/technology business development and/or drug development Experience in working at or with Digital Start ups and/or Digital Health technology companies with experience in a BD or partnership, consulting or deal-making role A passion for digital health and technology with the ability to identify and hone in on opportunities that will drive business impact Ability to work in a matrix organization McKinsey/Bain or BCG consulting experience if applicable in areas of Digital Delivery Experience with relationship management and executive level advisory role(s) Biotech or Pharma experience in an integrated technology environment Excellent verbal, written, and interpersonal communication skills, including the ability to set the context and present on complex subjects to senior management in a clear and concise manner High ability to deal with complexity and ambiguity, ability to see the big picture, ability to collect, digest and assemble information to enable relevant business analyses and facilitate decision-making Experience with Venture Capital Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Job Summary Amgen is seeking a Director Quality reporting directly to the Vice President, Final Product Quality and Surveillance. This team leads and manages the global Response to Questions (RTQ) process and ensures consistency in approach and deliverables globally. This may include facilitation, escalation and advice on critical issues. The team delivers ongoing monitoring of post market regulatory environment and identification of opportunities and improvements. The Director leads a global team of quality professionals, maintaining accountability for day to day operations of the team. Maintains a state of compliance across Final Product Quality in alignment with GxP (GMP, MDR, PMSR). Sets requirements and procedures to formalize global communication with Competent Authorities driven by Post- Market Surveillance programs. Ensures that there is an adequate number of qualified personnel who possess a combination of education, experience and training to perform the work in accordance with requirements and specifications. Key Responsibilities: Drives a global and consistent process for Responses to Questions (RTQ) as it relates to Final Product Brings together the necessary subject matter experts to ensure appropriate strategy for Responses to Questions (RTQ), Involved in the evaluation, impact assessment, and implementation of outcomes associated with Regulatory Trends and Risks Facilitate global support of Final Product Technology and Quality during internal audits and inspections relevant to Final Product & Surveillance (Complaints). Provides oversight of process for tracking, communicating and, managing CAPAs associated with internal and external audit/inspection commitments Drives insights generation through ongoing, active monitoring Identifies opportunities for improvement to regulatory communications and reporting (i.e., RTQ, BPDR, FAR, EuMDR) Leverages deep knowledge of Quality Management Systems to inform recommendations and improvement opportunities Facilitates inspection continuous improvement (e.g., summarizing lessons learned, takeaways from Management Review, etc.) to identify areas of greatest opportunity Ensures team's collaboration with Corporate Quality Compliance, Site Compliance, and Quality Leadership Teams to identify themes across the network Designs and provides oversight for management of the internal self-audit Final Product Quality program, leveraging the work of Corporate Quality Compliance Provides input into changes or improvements to the Quality Management System (QMS) Outlines infrastructure, strategy, and best practices for audit preparations to ensure consistency across Final Product Quality and Surveillance Participates in and coordinates inspectional preparation activities to prepare for domestic and foreign regulatory agency inspections Ensures a pool of subject matter experts are prepared to support audit and inspection activities Maintains responsibility as document custodian (e.g., playbooks etc.) Provides oversight to ensure compliance to SOPs, and teams are applying a consistent approach Identifies, interprets, and disseminates new regulatory trends, expectations and compliance documents Serves as an active member in the development of regulatory documents that provide guidance for the oversight of final product. Assesses the state of compliance with appropriate regulations and participates in the development of action plans to correct deficiencies Serves as Final Product Quality Compliance representative in group meetings and interacts with other departments in order to achieve goals Participates in the coordination, execution and closure of internal and for-cause audits and regulatory inspections for Final Product Evaluates and provides feedback to Final Product Quality team on potential compliance vulnerabilities Provides compliance-based recommendations and coordinates mitigation activities Oversees generation of compliance performance metrics and their presentation to key stakeholders and management as requested Provides compliance assessments as needed (examples: for validation philosophies, operational problem-solving exercises, SOP changes, technical reports etc.) Partners with Regulatory Affairs to draft and review regulatory submissions (INDs, BLAs, NDAs, other applications and supplements/amendments) Supports and identifies continual improvement initiatives, programs and projects Leads cross-functional initiatives Ensures execution of regulatory and SOP requirements Provides guidance and technical advice Basic Qualifications Doctorate degree and 4 years of Quality experience OR Masters degree and 8 years of Quality experience OR Bachelors degree and 10 years of Quality experience AND 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications 10+ years of quality and manufacturing experience in biotech or pharmaceutical industry Advanced Degree in a Science Field Knowledge of current Global regulations for final drug product, combination product, and devices and their application In depth understanding of Investigations and Root Cause Analysis Understands criticality of connectivity between product complaints and adverse events Significant experience hosting or participating in regulatory inspections Detail-oriented with experience in QA/QC functions across a broad range of manufacturing, QC and/or supply chain processes Ability to work in a team matrix environment and independently interact with various levels of management Excellent communication skills, both written and oral Ability to effectively present information to all levels of the organization with appropriate messaging and effective focus on desired outcomes Proven ability to create cross-functional networks/partnerships Ability to plan, monitor, and control a set of activities, ensuring efficient utilization of resources to achieve program objectives Leadership skills and the ability to oversee multiple projects simultaneously, including cross-functionally Able to successfully manage workload, timelines, and priorities Able to respond and provide astute advice quickly to difficult scenarios or in response to tough questions Ability to negotiate a strategic position after taking feedback from multiple sources Ability to operate in a matrixed or team environment with site, functional, and executive leadership Experience driving effective decision making Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device Manufacturing, Design Controls) Ability to succinctly communicate level of risk, urgency, or impact to the business Ability to travel +/- 20% of time to domestic and international Amgen sites Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Amgen is seeking a Corporate Information Technology Audit Senior Manager for our locations in Thousand Oaks, CA or Tampa, FL. This individual contributor will ensure that the Amgen good practice activities are conducted in accordance with regulations, policies and procedures. While reporting to our Director of Corporate IT audit, the Senior Manager will work with the Research and Development and Corporate Quality audit teams across global locations.Key responsibilities as part of this compliance team include: Participating in Internal Process & Service Providers audits to ensure compliance with good practices guidelines, FDA Part 11 regulations and Amgen Standard Operating Procedures Lead or participate in Systems Audits including the development of audit plans, tools, and conduct Detail and summarize auditing results and findings, including recommendations for corrective action or controls for risk mitigation Obtain audit responses from company functions or vendors and evaluate proposed Corrective Action Preventive Action (CAPA) for adequacy if implemented successfully Provide interpretation for internal and external customers on Code of Federal Regulations: Title 21, Part 11, International Conference on Harmonization guidelines for electronic company systems Contribute quality compliance data for metrical analysis Identify matters that require elevation to senior management on mitigation of risk and improving the efficiency of the Compliance Program Travel could include up to 30% domestic and international. Basic Qualifications: Doctorate degree and 2 years of corporate audit experience OR Masters degree and 4 years of corporate audit experience OR Bachelors degree and 6 years corporate audit experience OR Associates degree and 10 years corporate audit experience Or High school diploma / GED and 12 years corporate audit experience Preferred Qualifications: 10+ years of audit or compliance related experience in the biotechnology or pharmaceutical industry, with 5+ years of experience in an IT compliance/validation/quality role Experience in performing or supporting IT system audits or validation activities Proficiency in GxP Guidelines and regulatory requirements for the conduct of clinical trials and manufacturing of pharmaceutical products External audit (Third Party GLP/GCP/GMP vendors) and internal audit experience Knowledge and understanding of the internal control framework Experience with data analytics and data mining skills, including use of current analytical/BI tools for data analysis (Tableau, Spotfire, AMS) Ability to balance multiple activities in a fast-paced environment while delivering a timely and high-quality end work product Self-starter with excellent audit management and communication (both verbal and written) skills, including the ability to effectively and confidentially interact with Amgen senior management Strong interpersonal skills, with ability to forge collaborative relationships with all levels and functions of the organization Ability to prepare and present analytical written and oral communications appropriate for multiple audiences Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing, and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and demonstrates its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. We understand that to successfully sustain and grow as a global enterprise and deliver for patients we must ensure a diverse and inclusive work environment. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

HOW MIGHT YOU DEFY IMAGINATION? You've earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you've worked hard to acquire and the passion you already have. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role. SENIOR ASSOCIATE - BIOTECH/PHARMA MANUFACTURING Live What you will do Let's do this. Let's change the world. In this vital role you will work with a team responsible for supporting multiple Drug Product manufacturing operations, including formulation, sterile-isolator filling, aseptic filling, and lyophilization activities. The team owns the efforts of maintaining the highest levels of safety, quality, compliance, and efficiency while balancing a dynamic production schedule. The Associate will work to support multiple internal customers and partners including Supply Chain, Quality Assurance, Process Development, and Engineering. The Amgen, Pharma Product Manufacturing facility, in Thousand Oaks, directly supports Amgen's pipeline of clinical drug product supply to patients across the globe. The Sr. Associate Manufacturing - Drug Product role offers the opportunity to collaborate with multiple functions within the Thousand Oaks site on a routine basis in a dynamic environment (Quality Assurance, Quality Control, Engineering, Facilities, Maintenance, Process Development, Process Engineering, etc.) while developing a deep understanding of the manufacturing operations and planning activities within the facility! The Senior Associate Manufacturing will be specifically responsible for: Executing drug product filling and formulation activities, respectively Performing initial review of manufacturing batch records Maintaining a safe environment while adhering to compliance standards and by identifying additional preventative measures Crafting and/or revising standard procedures Leading continuous improvement initiatives, which may be multi-functional in nature Performing data analysis (e.g., SPC, CPV) of critical process parameters and making recommendations to Engineering and/or Process Development teams Developing finite schedule for tasks including, unit operations Reviewing efficiency and identifying countermeasures for issues impacting cycle time alignment Elevating critical and impactful events to management Utilizing appropriate systems for job duties (SAP, QMTS, and LIMS etc.) Supporting the introduction of new products and technologies into the facility Initiating and owning quality records, including but not limited to non-conformances (NC), Corrective/Preventative Actions (CAPA) Win What we expect of you We are all different, yet we all use our outstanding contributions to serve patients. The biotech manufacturing professional we seek is a collaborative team-player with these qualifications. Preferred Qualifications: At least 5 years of biopharmaceutical experience, including work within drug or pharmaceutical product manufacturing environment, which includes aseptic and sterile filling environments, as well as lyophilization Bachelor's or Master's degree in Microbiology, Life Sciences, Business or a related field An understanding of Lean concepts and application within a regulated manufacturing environment Ability to communicate and collaborate with technical and management staff within the manufacturing, quality and process teams Basic project management skills Demonstrates emergent leadership traits and strong cognitive resolution abilities Basic Qualifications: Master's degree Or Bachelor's degree & 2 years of operations or quality experience Or Associate's degree & 6 years of operations or quality experience Or High school diploma / GED & 8 years of operations or quality experience Thrive Some of the vast rewards of working here As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being. Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act Generous Total Rewards Plan-comprising health, finance and wealth, work/life balance, and career benefits-with compensation and benefits rated above 4 stars (out of 5) on Glassdoor Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com Equal Opportunity Statement Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

HOW MIGHT YOU DEFY IMAGINATION? If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us. Principal Engineer - Senior Manager of Engineering for Process Systems Engineering Live What you will do Let's do this. Let's change the world. In this vital role you will be responsible for technical direction, leadership, strategy and support for a broad array of systems with a focus in a specific area of Drug Substance Manufacturing Systems. This position encompasses both a leadership/managerial role and a technical network lead SME role within the process equipment and systems engineering team. The successful candidate will lead a team of 5-7 Senior engineers within the Process Systems engineering team which includes Drug Substance, Drug Product, Final Drug Product and Process Support systems (Cleaning, Sterilization, Single use). The candidate will also provide technical network leadership and expertise of a specific technical equipment area such as Upstream Processing, or Cleaning and Sterilization (or others). Key elements of the position will be to own, develop and maintain standard equipment designs within the area of expertise, to provide network leadership to drive alignment, solve problems and prevent issues within Amgen's manufacturing network. The position will also provide direct project engineering leadership for critical capital projects, as well as providing managerial oversight for a team of SMEs with similar responsibilities for other technology areas. To accomplish Amgen's objectives, the position will strongly partner with Manufacturing, Process Development, Quality, EH&SS and other functions as Amgen maintains our goal of best in class manufacturing to serve every patient every time. The position is part of the ETA organization that includes Process Systems, Facilities and Utilities, Site Project Engineering, Maintenance and Metrology functions. This position is part of Amgen's Process Systems Engineering Leadership Team. The Sr Manager deploys engineering expertise from within the company (global and site-based experts) as well as expertise from our industry to optimize Amgen's assets throughout their life cycle. They lead a small team of senior level engineers who act as network leads and project engineers at sites in support of Amgen facilities in the USA, Puerto Rico, Ireland, Netherlands and Singapore, as well as leading a specific technical network focus area supporting the Amgen manufacturing network. Specific system responsibilities would be in an area of Drug Substance manufacturing, either upstream, downstream or cleaning and sterilization systems. A key aspect of this role includes ownership of Amgen's specification and standard designs for equipment in the area of responsibility. Through their team, and partners this manager is has responsibilities for: Planning: Translate business needs into engineering technology solutions. Lead analysis of alternatives and recommendations for technical solutions in major projects. Publish and maintain engineering standards and specifications. Lead Engineering in development and execution of corporate environmental sustainability goals & projects. Design: Lead design and equipment selection to optimize quality and cost across the total life cycle of assets. Ensure appropriate use of technology, and adherence to standards/practices. Approve appropriate exceptions to Amgen standards and specifications. Construction: Provide engineering support during construction, resolve technical issues, and ensure project objectives are met. Ensure commissioning standards are developed and implemented during system qualification. Operations and Maintenance: Review performance data and recommend improvements for systems. Develop and approve maintenance standards and techniques. Assist sites in troubleshooting, and remediation to prevent future occurrence throughout the network. Support the long-range plan for Maintenance. Sustainability: Support Amgen's environmental sustainability Management: Provide day to day management and leadership including mentoring, staff development and work prioritization for a small team of process equipment engineering. Providing input into department objectives and establishment of strategic direction within the Process Systems team. This position can be located at the following Amgen sites: ATO (preferred), ARI, AMA, AML. The position requires the ability to travel up to 25% including overnight stays. Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Senior Engineering Manager we seek is a collaborative and forward thinking professional with these qualifications. Basic Qualifications: Doctorate degree and 6 years of direct experience in Engineering or a related technical discipline OR Master's degree and 10 years of direct experience in Engineering or a related technical discipline OR Bachelor's degree and 12 years of direct experience in Engineering or a related technical discipline AND Minimum 6 years of managing people in a multi-tiered organization and directing the allocation of resources Experience leading teams, projects, and programs Preferred Qualifications: Proven experience leading design in support of capital projects Prior experience leading engineers or other technical professionals Professional Engineer license Extensive experience providing technical support to manufacturing processes, equipment and facilities Proven experience and track record of compliance in a highly regulated environment Demonstrated ability to effectively lead and partner in a complex, matrixed organizations Successful deployment of continuous improvement methodologies (e.g., Lean, Six Sigma, Total Quality Management, Reliability Centered Maintenance, Root Cause Analysis tools, etc.) Competencies: Capabilities to hire, develop and lead a diverse workforce Financial acumen to deploy initiatives that add shareholder value Excellent communications skills, strong facilitation talent, and executive presence to drive cross functional objectives across Amgen's international network Strong analytical skills to identify potential improvement opportunities Knowledge of industry trends (e.g., regulatory and compliance, technology, human performance programs, sustainability, asset insurance, etc.) to stay at the forefront of technology implementation Knowledge of applicable regulations (e.g. cGMP, building codes, Boiler and Pressure Vessel codes, etc.), to ensure compliance. Represent Amgen with outside firms, technical societies and regulatory bodies. Ability to develop, implement and utilize tools to drive efficiency in meeting business needs; establish measure and evaluate performance metrics, taking actions based on results. Thrive What you can expect of us As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being. Vast opportunities to learn and move up and across our global organization Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits Apply now for a career that defies imagination In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us. careers.amgen.com Equal Opportunity Statement Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. ..... click apply for full job details

HOW MIGHT YOU DEFY IMAGINATION? You've earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you've worked hard to acquire and the passion you already have. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role. Senior Engineer - Facilities and Engineering Drug Product Supply Live What you will do Let's do this. Let's change the world. In this vital role you will be joining Facilities & Engineering (F&E) group within Development Supply Chain organization at Amgen. The group's mission is to enable introduction and integration of new technologies while ensuring existing clinical and commercial facilities and equipment operate reliably. Provide system ownership for Biopharmaceutical process equipment. Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment. Advising and coordinating equipment maintenance as vital to ensure systems are in proper working order. Ensure vital commissioning and qualification of systems is completed and interact with inspectors as necessary. Supervise systems to identify performance risks and implement risk reduction strategies. Providing troubleshooting support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action. Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs. Ensure systems are installed, operating safety and align with pertinent environmental health/safety practice, rules and regulations. Up to 10% domestic/international travel Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The team-oriented professional we seek is an engineer with these qualifications. Basic Qualifications: Doctorate degree OR Master's degree and 3 years of Engineering experience OR Bachelor's degree and 5 years of Engineering experience OR Associate's degree and 10 years of Engineering experience OR High school diploma / GED and 12 years of Engineering experience Preferred Qualifications: Bachelor's degree in Chemical or Mechanical Engineering 6 plus years of relevant work experience with demonstrated ability in Biopharmaceutical operations/manufacturing environment Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment /systems such as continuous fill lines (washer, tunnel, isolator, cappers and lyophilization), filling, lyophilization, inspection, device assembly, cell culture reactors, chromatography, filtration as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc. Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data techniques and analyses (e.g., Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.) Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and completion of capital projects Understand the processes of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and validation Understanding of safety requirements working in a GMP Biopharmaceutical Production facility. Independent, results-oriented, organized, able to multi-task in project environments, and skilled in communication, facilitation, and teamwork Phenomenal teammate prepared to work in and embrace a team based culture that relies on collaboration for effective decision-making Thrive Some of the vast rewards of working here As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being. Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act Generous Total Rewards Plan-comprising health, finance and wealth, work/life balance, and career benefits-with compensation and benefits rated above 4 stars (out of 5) on Glassdoor Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com Equal Opportunity Statement Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

HOW MIGHT YOU DEFY IMAGINATION? If you feel like you're part of something bigger, it's because you are. At Amgen our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us. Sr. Manager Engineering: Final Product Technologies Development Live What you will do Let's do this. Let's change the world. In this vital role you will manage a diverse team responsible for identification, development, commercialization, and continuous improvement of drug delivery technologies to optimize the patient experience for Amgen's portfolio of therapeutic products. The Development Product Engineering (DPE) Senior Manager leads a multi-disciplinary team that creates drug delivery solutions, which meet user requirements from concept through commercial entry. The Senior Manager oversees technical programs and teams that contribute to design requirements, identification and realization of technical solutions, authoring of test methods and reports, and authoring of technical analyses to advance programs. This position provides oversight for concept and development stage solutions to serve user needs and the needs of the pipeline portfolio, leveraging a range of program tools, design characterization and verification methods and design reviews. In addition, you will certify the required performance and quality targets are satisfied and help identify and reduce technical risks on the program. Finally, the Sr Manager confirms that the team is aligned with the tasks by providing mentoring, coaching, evaluations and hiring when applicable. Responsibilities: Oversight of drug delivery technical teams and projects in different therapeutic areas, including nephrology, bone health, oncology, inflammation, and cardiovascular. Lead investment analysis for drug delivery technologies through demonstration that proposed solutions meet user needs in service of Amgen's product pipeline. Manage technically and culturally diverse teams. Communicate effectively at multiple organizational levels on project status, staffing topics, risks, issues and accomplishments. Successfully impact program outcomes. Review completed design work with both internal and external design partners. Utilize project planning and monitoring methods to ensure timely completion. Ensure compliance to Regulatory and Quality requirements when overseeing design outputs and conducting technical reviews. Interface with the commercial engineering organization to ensure adequate sustainment and enhancement of products throughout their lifecycle. Facilitate development of solutions to critical business issues. Effectively define objectives to enable accurate metrics generation and reporting. As part of the organization developing device platforms, ensure adherence to architecture to support variations of the platform and system deliverable packages. Win What we expect of you Basic Qualifications: Doctorate Degree and 2 years of Engineering or Medical Device experience OR Master's Degree and 6 years of Engineering or Medical Device experience OR Bachelor's Degree and 8 years of Engineering or Medical Device experience OR Associates degree and 10 years of Engineering or Medical Device experience OR High School Diploma / GED and 12 years of Engineering or Medical Device experience And 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources We are all different, yet we all use our unique contributions to serve patients. The vital Engineering professional we seek has these qualifications: Master's degree in Mechanical, Biomedical Engineering, Polymer Engineering or Materials Science. 5+ years of experience in the Pharmaceutical/Biotechnology industry or Medical Device industry. Working knowledge and familiarity with US Quality System Regulations for Medical Devices (21CFR820) and International Quality Management Systems for Medical Devices (ISO 13485). Previous experience managing teams of highly skilled engineering staff. Strong oral and written communication skills, decision making, presentation, and organization skills. Proven ability to collaborate and converse technically with diverse partners. Demonstrated ability to navigate ambiguity and provide a structured problem-solving approach. Organizational savvy and presence to build effective relationships across functions. Working knowledge of MS Office tools. Thrive What you can expect of us As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being. Vast opportunities to learn and move up and across our global organization Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits Apply now for a career that defies imagination In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us. careers.amgen.com We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation. Equal Opportunity Statement Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

HOW MIGHT YOU DEFY IMAGINATION? You've earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you've worked hard to acquire and the passion you already have. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role. Senior Automation Engineer - Inspection & Packaging Live What you will do Let's do this. Let's change the world! In this vital role you will be responsible in the development, modification and operational support of complex automated equipment in a compliance regulated industry, required to meet company production schedule goals and new product introductions. Specific responsibilities include but are not limited to: Develop process control applications using Programmable Logic Controllers (PLC), Distributed Control Systems, Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA). Provide automation solutions to a variety of technical problems of moderate to advanced scope and complexity. Work with Research, Manufacturing, Maintenance, Process Development, System Owners, Utilities, Facilities, Quality Assurance and/or Validation departments in developing requirements and recommendations for system modifications and new equipment, selecting and applying automation engineering standards and procedures. Function as a technical expert of equipment for troubleshooting operations. Frequently becoming actively involved in daily operations to comply operational goals or to resolve complex problems. Support compliance deviations root cause evaluation related to automated systems. Implements preventive and corrective actions necessary to avoid reoccurrence of observed automation and process deviations. Support qualification life cycle of new automated equipment and/or existing equipment modifications, ensuring the established machine requirements are met. Provides direct support of the technical skill development of Maintenance Automation personnel and facilitate the introduction of new technology. Win What we expect of you We are all different, yet we all use our unique contributions to serve patients! The Senior Automation Engineer professional we seek is an individual contributor leader with these qualifications. Doctorate degree OR Master's degree in Engineering & 3 years of Engineering/Automation experience in a GMP regulated industry OR Bachelor's degree in Engineering & 5 years of Engineering/Automation experience in a GMP regulated industry Beyond that, additional preferred qualifications are: Background in programming, design, installation and life cycle management of manufacturing process controls, automation and/or Packaging Vision System technologies. Working knowledge of pharmaceutical/biotech packaging processes and equipment. Familiarity with validation processes and documentation in a highly regulated environment. Strong verbal and written communication skills in English and Spanish. Comprehensive understanding of validation protocol execution requirements. Experience in Packaging Vision System & serialization platforms (Systech, Cognex, etc) Broad hands on experience in Rockwell Automation Platform and Allen-Bradley PLCs, Rockwell Automation Factory Talk & ControlLogix PLC Platform. Rockwell SLC500 PLC families Controllers. Rockwell Automation FTView SE and FTBatch systems. Experience in Siemens control systems is a plus. Knowledge in DeviceNet technologies. Work schedule flexibility to support 24/7 operations. Knowledge of ASTM 2500, ISA S88 and S95 techniques. Knowledge in programming language structure (e.g. VBA) and/or AI. Thrive Some of the vast rewards of working here As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being. Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act Generous Total Rewards Plan-comprising health, finance and wealth, work/life balance, and career benefits-with compensation and benefits rated above 4 stars (out of 5) on Glassdoor Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us: careers.amgen.com Equal Opportunity Statement Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

HOW MIGHT YOU DEFY IMAGINATION? You've earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you've worked hard to acquire and the passion you already have. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role. SR INSTRUMENT TECHNICIAN Live What you will do Let's do this. Let's change the world. In this vital Sr Instrument Technician (1st shift) role you will perform calibration, repair, installation, and troubleshooting of instruments, process control systems, and equipment used in ARI site. The Senior Instrument Technician reports to our Manager of Maintenance. Responsibilities for this position will include: Perform instrument calibrations for process, utility and analytical equipment and systems Troubleshoot and repair site instrumentation and control system issues Perform advanced maintenance and repair activities on equipment and systems used in Manufacturing, The Process Develop Laboratory, The Quality Analytical Laboratory or other areas of the ARI site. Ensure activities are accomplished in a safe manner. Ensure work is completed in accordance with procedures. Ensure work activities are completed accurately. Improve right the first time performance. Work in a highly productive and efficient manner to maximize the quantity of activities completed. Ensure work is appropriately communicated to system operators and key partners. Ensure work order documentation is completed accurately and completely. Identify waste, work flow interrupters, and other opportunities for improvement, recommend solutions, and assisting with implementation. Find opportunities to learn new skills and actively participate in development that will improve overall team performance. Provide support - this may be outside of normal working hours including nights, weekends and holidays. Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Sr Instrument Tech professional we seek is a collaborative team-player with these qualifications. Basic Qualifications: Associate's degree and 4 years of Maintenance or Instrumentation experience OR High school diploma / GED and 6 years of Maintenance or Instrumentation experience Preferred Qualifications: 8 + years of combined education, training, and experience with instrumentation and associated calibration procedures Ability to work with minimum direction Knowledge of Maximo CMMS System Advanced understanding of process control loops, loop checks, and loop tuning of mfg process control systems Experience with Rosemount instrumentation, Foundation Fieldbus communications, and Delta V process control system Formal instrumentation education or training (Associates Degree, Armed Services, or other substantial technical training program(s)) Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Thrive Some of the vast rewards of working here As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being. Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act Generous Total Rewards Plan-comprising health, finance and wealth, work/life balance, and career benefits-with compensation and benefits rated above 4 stars (out of 5) on Glassdoor Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com Equal Opportunity Statement Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Amgen is searching for a Finance Manager to play a key role on the team supporting Finance process and technology requirements for Amgen's Financial Planning & Analysis (FP&A) organization. The Finance Manager will report to the Senior Manager Finance based at Amgen's Capability Center in Tampa, FL. At Amgen, our mission is simple: to serve patients. Our new Tampa Capability Center provides essential services that enable us to better pursue this mission. This state-of-the-art center serves as a base for finance, information systems, and human resources professionals to make a meaningful impact at one of the world's leading biotechnology companies Key Activities for the Finance Manager include: The Finance Manager will be part of a team that will be responsible for supporting Amgen's FP&A organization by: Overseeing annual budget / LRP and quarterly forecast processes to ensure the system process is well planned, supported and executed Driving data quality and integrity in the Hyperion Financial Planning and Reporting system (FPR); understanding the data relationships and data flows between various systems including SAP, EDW and FPR Developing and executing plans to analyze, identify, test and resolve operational issues Collaborating effectively and actively with key business partners to identify and implement continuous process and system improvements to drive business initiatives Supporting system training programs and conducting training sessions to global business users Designing and creating standard and ad hoc financial reports that improve insight and transparency into financial results / plans Basic Qualifications: Doctorate degree OR Master's degree and 2 years of Information Systems and / or Finance experience OR Bachelor's degree and 4 years of Information Systems and / or Finance experience OR Associates' degree and 10 years of Information Systems and / or Finance experience OR High school diploma / GED and 12 years of Information Systems and / or Finance experience AND Previous managerial experience directly managing people and/ or experience leading teams, project, programs or directing the allocation of resources Preferred Qualifications: Experience in using and / or supporting Oracle Hyperion Planning (HP), Data Relationship Management (DRM) and Hyperion Profitability and Cost Management (HPCM) Experience with Smartview Queries over Essbase Bachelor's degree in one or more of the following: Finance, Accounting, Computer Science, Finance Management Information Systems 2+ years' experience in functional knowledge of financial budgeting and reporting processes in large company environment Experience with financial reporting, metrics and key finance performance indicators Strong organizational skills and ability to work with technical (IT) and Finance teams Ability to build and maintain relationships across various levels and functions Ability to manage change and process improvements effectively Ability to work effectively in teams Candidate should have strong analytical skills, as well as good interpersonal and communication (written and oral) skills Strong computer literacy and the ability to learn new applications readily Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. The invaluable contributions of our talented Tampa team will help us develop the vital and innovative medicines that treat serious illness and unmet medical needs around the globe. Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do. We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions. Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Sr Mechanical Engineer- Device Engineering Amgen is currently seeking a Senior Mechanical Engineer in our Device Engineering group to support technical teams in the successful design, development, testing, and transfer of drug delivery devices. The Senior Mechanical Engineer is an experienced mechanical design engineer possessing a broad knowledge set and expertise in complex, multi-disciplinary, cross-functional product design and development efforts. In support of Amgen's mission to serve patients, the Device Engineering group at Amgen is a diverse team working to identify, develop, commercialize and continuously improve drug delivery devices in order to optimize the patient experience. The Senior Engineer will interact with global and cross-functional members from systems engineering, process engineering, device development, packaging, primary containers, device quality, and other groups. Responsibilities of this position include development, testing, transfer, and life cycle management of multiple autoinjector device commercialization efforts. Test activities will include Engineering, Characterization and GMP Verification testing and will require a strong proficiency in developing test protocols, executing hands on testing, and reporting of results to senior leadership. This role will interface with customers and vendors to facilitate the proper planning and execution of design activities including CAD design, Testing, Tool/Fixture design and Methods development. The person selected for this position will work closely with project team members to ensure that best practices are used in the execution of mechanical designs and in development of detailed engineering specifications. The person will perform device design and development, testing, analysis, modeling and design verification activities. The successful candidate may also participate in design transfer activities, test method development, and design control activities. Basic Qualifications Doctorate degree and 2 years of Engineering experience OR Master's degree and 6 years of Engineering experience OR Bachelor's degree and 8 years of Engineering experience OR Associate degree and 10 years of Engineering experience OR High School diploma / GED and 12 years of Engineering experience Responsibilities: Provide complex mechanical design support to the mechanical engineering design organization Technical documentation (Test Plans/Protocols/Reports, Engineering Assessments, Design outputs, test-lab equipment/process/control) Prepare and provide communications to leadership in support of recommendations and assessments Verification testing strategy to include the differentiation between Platform and Combination Product testing to ensure minimum duplication and maximum efficiency when executing against additional programs Ensure tests methods and test protocols are developed in a sound and robust framework with high focus on eliminating test errors Execute hands on testing of autoinjector devices, including the safe operation of test equipment Collaborate with and support manufacturing sites on design/fabrication of assembly and labeling equipment Perform solid modeling (SolidWorks) and create drawings using best practices in accordance with ANSI/ASME Y14.5 Geometric Dimensioning and Tolerancing Standard and Y14.100 Engineering Drawing Practices Contribute to and/or lead execution of drug delivery design projects in different therapeutic areas, including nephrology, oncology, psoriasis, RA Develop, execute, and review mechanical specifications, development plans, characterization plans, and other related development documents for assigned projects Assess product requirements to determine coverage of mechanical design Provide technical assistance for mechanical problems to programs as needed Evaluate alternative design concepts and perform trade-off analyses Perform technical analyses and develop design solutions that will meet reliability targets and reliability allocations to components Tolerance and robustness analysis of complex mechanical designs Create and maintain design control documents Develop and execute verification plans and procedures Design with emphasis on DFM/DFA; with close collaboration and input from manufacturing team and other engineering groups Preferred Qualifications Master's Degree in Engineering, preferred Mechanical, Electrical, or BioMed 6 or more years of progressive experience as an engineer within the medical device design field 3 or more years of experience in project leadership within a development or research, manufacturing environment, working with Medical Devices, ideally Class II and Class III Broad set of knowledge and expertise in leading complex, multi-disciplinary and cross-functional product development efforts Experience in drug/device combination product design and development Background in development, commercialization, and lifecycle management of medical devices Solid experience in documentation authoring from project start to end Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA Experience executing lab tests, including safe and proper operation of lab equipment (Instron tensile tester, Keyence inspection equipment, etc.) Experience conceptualizing, designing and building test fixtures Demonstrated broad exposure to HW/SW/Systems design and technical depth in one or more engineering disciplines (Electrical, Mechanical, Software, etc.) Experience in injection molded plastic part design, molding process, 3D solid modeling and device assembly Proficiency in FEA and SolidWorks 3D solid modeling of parts, large assemblies and advanced surface design Technical understanding of drawings including tolerance stacks and robustness analysis Proficiency with SAP PLM with SolidWorks integration for enterprise Experience in leading projects from development approval process. - Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions Leadership ability for Characterization, Verification and Validation testing of System and Subsystem Level Performance and Reliability characteristics Deep knowledge of Quality Management System, Quality Management Policy and applicable laws and regulations as they apply to this job type/position Familiar with the following standards: US Good Manufacturing Practices (21CFR820), Quality Management (ISO 13485), Risk Management (ISO 14971), EU Medical Device requirements (Council Directive 93/42/EEC), and Medical Electrical Equipment (EN 60601) Strong background in documenting requirements and providing traceability documentation for FDA Approval - DOORS, Requisite Pro, or other similar requirements management software Knowledge of dFMEA/pFMEA Practical experience in configuration management and change control process/requirements - CCB (change control board), CIT (change implementation team) concepts Demonstrated Design for Six Sigma competency Strong communication and interpersonal skills Strong problem solving, risk assessment, and risk management skills Capable of working on multiple projects in a deadline driven environment Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin..... click apply for full job details

Amgen is searching for a Senior Counsel - Patent - Biosimilar/Innovator Biologics in our Intellectual Property and Litigation group. The position is based at Amgen's corporate headquarters campus in Thousand Oaks, California, but due to the COVID-19 pandemic, the position can initially be based remotely until staff in this role return to work at the Thousand Oaks site. The Senior Counsel will develop, implement and execute a market access strategy for Amgen's biosimilar and/or innovator molecules, including freedom-to-operate analyses for drug substance, drug product, formulations, processes, and methods of treatment. The Senior Counsel will work in all aspects of intellectual property, especially in identification of relevant patents, conducting searches for prior art, analyzing third party patents, developing persuasive legal arguments, drafting opinions, working with experts, and performing other pre-litigation activities. Other responsibilities for the Senior Counsel could include related worldwide patent procurement and patent litigation support. Other responsibilities for the Senior Counsel could also include developing and implementing global freedom-to-operate strategies for Amgen products in collaboration with other in-house attorneys. This could include ensuring consistency among arguments in multiple countries. The Senior Counsel will also be responsible for developing and counseling others on intellectual property strategies associated with Amgen's business and research endeavors. The Senior Counsel will work individually, in legal teams, and in cross-functional business teams. 10% domestic and global travel anticipated. Basic Qualifications: J.D. degree or LL.M. degree from an accredited law school, admission to practice law in a U.S. jurisdiction; four (4) years of experience practicing intellectual property law; and registration to practice before the U.S. Patent and Trademark Office. Preferred Qualifications: 7+ years of experience practicing patent or intellectual property law. Enthusiasm for joining a cutting-edge biosimilar practice group at a leading biotechnology company. Experience in U.S. and/or foreign intellectual property law relating to biotechnology at a law firm or biotechnology/pharmaceutical corporation. Experience in U.S. and/or foreign adversarial proceedings (such as patent litigation, Inter Partes Reviews, Post Grant Reviews, or oppositions), including experience developing and implementing a global freedom-to-operate strategy. Undergraduate degree in the sciences and a working understanding of molecular biology, cell biology, microbiology, biochemistry, genetics, immunology, structural biology, pharmaceutics, or chemical engineering. Preferably, an advanced degree, such as a Master's or Ph.D., or research experience in one of these areas. Excellent judgement, analytical skills, legal drafting and oral and written communication skills. Strong management and client counseling skills. Ability to work independently and in teams, navigate through ambiguity, work efficiently, prioritize workflow, meet fast-paced deadlines, and manage multifaceted projects in a fast-paced environment. Amgen is committed to unlocking the potential for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do. At Amgen, contributions are recognized - and strong performance is rewarded. Regularly recognized as a "Best Place to Work," we enable staff to chart their own career paths based on their unique talents by offering meaningful assignments, active career development, mentoring and individual rewards. #LI-POST Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

The Data Platforms and Operations Senior Manager will be responsible for oversight, governance and administration of Amgen's global commercial data and analytics warehouse and lead cross functional data and analytics enablement efforts. This role will report to the Senior Manager of Data Sciences and will be part of a cross functional data governance team to ensure timely and accurate data for business analysis and decision making. Responsibilities include but are not limited to: Lead the global commercial data lakes at Amgen as a business owner Lead and participate in strategizing the creation of outstanding data and analytics platforms Lead new capabilities, including but not limited to, requests that have an impact on multiple domains in pharma (ex. Medical, commercial, compliance, etc.) Development of data science, machine learning and artificial intelligence roadmap and capabilities for on a global scale Responsible for the management of both identified as well as de-identified patient data sets Develops and Oversees ongoing Data Governance & Administration for both Operational and Analytical needs Primary Global Lead for all connected data in the organization's global data lake Creating prototypes and demos to better access and utilize data Be an integral part of cross functional teams on projects and/or programs with aims to systematically derive insights that drive substantial business value for Amgen and our patients Identifying business needs and proposing potential analytics approaches for solutions Creating prototypes and demonstrations to better access and utilize data assets Presenting analysis ideas, progress and results to leadership and business partners Ensuring systems meet business requirements and industry standards Assuring compliance with regulatory, security, and privacy requirements as it relates to data assets Ad hoc projects and analysis would be a standing 10-20% of the role Basic Qualifications: Doctorate degree and 2 years of analytics experience OR commercial operations experience Or Master's degree and 6 years of analytics experience OR commercial operations experience Or Bachelor's degree and 8 years of analytics experience OR commercial operations experience Or Associate's degree and 10 years of analytics experience OR commercial operations experience Or High school diploma / GED and 12 years of analytics experience OR commercial operations experience Preferred Qualifications: Biotech and/or pharma industry experience Multiple functional experience (i.e. Medical, Commercial, Compliance, Finance, etc.) Experience in implementing and building global capabilities Experience with working in a global role MS in Engineering, Computer Science, Mathematics, Applied Physics, Statistics, Operations 8+ years of relevant work experience in commercial operations Prior business consulting experience in technology domain Motivated teammate with experience in problem solving, data, analytics and operations Experience with pharmaceutical data sets such as patient level data sets, sales data sets (XPO, DDD, chargebacks, vendor data) and Claims datasets (SHS, IQVIA), publications, KOLs, Medical activity data etc. Ability to direct and lead work through others (e.g. cross-functional partnership and/or vendor) Detailed, technical aptitude with strong logical, problem solving, and decision-making skills Cross functional and leadership negotiating and influencing skills Training and presentations skills from prior experience Excellent organization/planning skills and talent for managing many large and complex datasets Ability to collaborate, partner and influence leadership/business partners and other IS resources to drive analytic projects end-to-end Ability to communicate analysis in a clear, detailed, and impactful manner Passion for learning and staying on top of current developments in advanced analytics Basic data access and wrangling skills like SQL, Tableau, Spotfire, Thoughtspot Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Amgen is a values-based organization with a powerful sense of shared purpose toward our mission: to serve patients. Within Global Commercial Operations, we provide the capabilities, resources, and rewards of a global enterprise, while maintaining the entrepreneurialism and verve that marked our early days as a biotechnology pioneer. We encourage our team members to have fulfilling and meaningful careers through challenging assignments, career development, and valuable opportunities. As part of a new group within Commercial Data and Analytics - Data Sciences, the Data Scientist Sr. Associate will collaborate with business partners, service owners and IS peers to define and manage a capability and technology roadmap for delivering optimized user experience for data consumers across the US Commercial Organization. This role will innovate and create significant business impact through the strategic use of technology and information. This position will help create competitive advantages for Amgen with the ultimate aim to provide clean, usable data to whomever may require it. This position will be primarily responsible for: Ensuring rapid access to new and existing data assets Researching opportunities for data acquisition and new uses for existing data Overseeing end to end data integration and curation including building quality into the process Creating prototypes and demonstrations to better access and utilize data assets Employing a variety of languages and tools (e.g. scripting languages, big data tools) to marry systems together Collaborating cross-functionally with internal partners to ensure a superb user experience throughout the data integration process Managing back-end data configuration Creating data models and solutions architecture in collaboration with IS and external partners Defining processes for managing access to data sets Triaging issues and working with external partners as needed Developing tools and training on data sets and access Collaborating to design, construct, install, test and maintain highly scalable data management systems Ensuring systems meet business requirements and industry best practices Collaborating on definition and implementation of disaster recovery procedures Recommending and implementing ways to improve data reliability, efficiency and quality Collaborating with data architects, modelers and IT team members on project goals Verbally presenting analysis ideas, progress and results to IS peers and business partners. Providing high quality ongoing support; answering questions, resolving problems and building solutions. Assuring compliance with regulatory, security, and privacy requirements as it relates to data assets Serving as an internal consultant on commercial data and data quality management Identifying, recommending and driving continuous improvement in database reporting and analysis processes Basic Qualifications: Master's degree OR Bachelor's degree and 2 years of Data Modeling and/or Data Science and/or Mining and Information Systems experience OR Associate's degree and 6 years of Data Modeling and/or Data Science and/or Mining and Information Systems experience OR High school diploma / GED and 8 years of Data Modeling and/or Data Science and/or Mining and Information Systems experience Preferred Qualifications: Master's Degree in Science, Engineering, Mathematics, Applied Physics, Statistics, or Operations Research 3+ years of relevant work experience Experience with databases Programming experience Detail-oriented technical aptitude with strong logical, problem solving, and decision-making skills. Excellent organization/planning skills and talent for managing many large and complex datasets. Ability to prototype data driven solutions to problems Ability to collaborate with business partners and other IS resources to drive analytic projects end-to-end. Ability to communicate analysis in a clear, precise, and actionable manner. Experience working with large data sets Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Amgen is seeking a Companion Diagnostic Regulatory Affairs Manager to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. This particular role will focus on collaborating with Amgen's China partner, BeiGene, to develop diagnostic regulatory strategies that enable successful marketing authorization of diagnostics and therapies for patients in China. Additionally, the Regulatory Affairs Manager will support in establishing sustainable processes, assuring informed relationships, and delivering strategic outcomes. The lead will also specifically develop and implement regulatory strategies and processes for in vitro diagnostics (IVDs)/companion diagnostics (CDx's). Responsibilities of the Regulatory Affairs, Manager include: Providing critical strategic and tactical IVD/CDx regulatory guidance that positively influences project planning & decision making. Developing clinical and commercial regulatory strategies for assigned products to enable successful study designs and timely registration of both therapeutic and diagnostic products by regulatory health authorities. Providing regulatory leadership and input to internal teams involved with IVD/CDx development planning, including Diagnostic Development Teams, and to Joint Project Teams with diagnostic partners. Handling interactions with diagnostic partners to mutually align on co-development regulatory needs and expectations for major project tasks, including regulatory submissions (e.g. PMA, 510(k), IDE). In collaboration with diagnostic partners and internal teams, preparing for and executing meetings with regulatory agencies. Review and approval of key diagnostic regulatory submissions to CDRH and global health authorities (as agreed with diagnostic partners) and corresponding therapeutic dossiers. Interacting with international regulatory colleagues and diagnostic partners to determine best practices & least burdensome regulatory paths towards development & global registration activities. Assessing impact of relevant drug and IVD/CDX regulations on drug and IVD/CDX development & registration activities, respectively. Regulatory support of due diligence activities of external CDx/IVD companies that Amgen may be considering as partners and other due diligence activities as needed. Basic Qualifications: Doctorate degree OR Master's degree and 2 years of Health Agency or Med-Device or Regulatory experience OR Bachelor's degree and 4 years of Health Agency or Med-Device or Regulatory experience OR Associate's degree and 10 years of Health Agency or Med-Device or Regulatory experience OR High school diploma / GED and 12 years of Health Agency or Med-Device or Regulatory experience Preferred Qualifications: MS Degree Degree in Regulatory Affairs, Life Sciences, or Engineering 6 plus years of experience in Regulatory Affairs, including China, United States and other international medical device and/or IVD/CDx regulations 8 plus years of experience in medical device and/or IVD/CDx industry Amgen provides a collaborative and creative culture in a company with a strong track record of innovation. Our culture encourages open dialogue and diverse views to land on the best solutions, and we help ensure our staff are equipped to excel today and tomorrow. Amgen focuses on areas of high unmet medical needs and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Are you looking for a meaningful new opportunity to test and growth your technical skills? We have an immediate need for Sr Associate QA's to join AML's Quality Organization. This is an outstanding opportunity to seek a variety of challenges and responsibilities in support to our manufacturing facility at Amgen Manufacturing Limited in Juncos, Puerto Rico. The Role: The Sr Associate QA role will support operations at the AML Inspection and Packaging Facility in a Non Standard Shifts Operations. The manufacturing operations require a seven (7) days a week coverage. Perform one or more of the following duties and responsibilities in support of Amgen's Quality Assurance program under general supervision. Specific responsibilities include but are not limited to: Perform Quality Oversight of Operations Sampling of product Compliance review of batch record elements (e.g., MPs, MO) and identification of discrepancies Participate in internal plant audits Work with operations to resolve basic compliance discrepancies Assist in Investigations May perform work of Associate QA Basic Education & Experience: Master's degree or Bachelor's degree and 2 years of Quality experience in pharmaceutical, medical device or biotechnology industry Preferred qualifications: Educational background in Life Sciences or Engineering Basic statistical mathematical skills Basic knowledge of process and facility equipment Knowledge in systems like Trackwise, Electronic Batch Record (EBR), SAP, LIMS, BTRS GMP knowledge with ability to interpret and apply in routine cases Technical writing capability Proven skills in problem solving and providing solutions Ability to interface optimally with various levels Basic understanding of analytical methods used in support of facility process monitoring Self-motivated Ability to work as a team player and/or independently Ability to evaluate documentation/ operations according to company guidelines Intermediate word processing, database, presentation and spreadsheet application skills Skill in prioritizing and meeting deadlines Good communication and presentation skills (both written and verbal) Independently understand, follow and implement instructions Ability to seek outside resources as needed The benefits: Our broad approach is one of the reasons why we are regularly recognized as a 'Best Place To Work'. We offer an outstanding benefits package that includes an award-winning retirement and stock plan. And between the paid time off, and wellness program - and on-site child care and fitness facilities - you will find us passionate about your well-being too. Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do. We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions. Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and demonstrates its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Amgen is a leading human therapeutics company in the biotechnology industry. For more than 35 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients. Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen is searching for a Senior Associate within the Regulatory Optimization of Tactical and Strategic Support (ROOTS2) group in RA CMC. The ROOTS2 team supports CMC submission execution for the Amgen products across phase of development, moiety and region. The RA CMC Senior Associate will interface with the Amgen RA CMC global and regional teams, site regulatory, the biosimilars unit as well as the device team for specific strategies or activities that impact a product. The RA CMC Senior Associate will be responsible for varying levels of product support, including leading projects, based upon their experience level. Additional job responsibilities of the RA CMC Senior Associate include: Contribute as a key member of the global regulatory CMC product team Interact with authors/reviewers and subject matter experts with respect to delivery of regulatory documents required for regulatory submissions Contribute to the organization and preparation of CMC investigational product amendments, post‑market supplements/variations, and new marketing applications Lead the organization and preparation of the CMC sections of global annual notifications to meet regulatory requirements Document and archive CMC submissions and related communications in the document management system Initiate and maintain CMC product timelines at the direction of product lead Interface with the regulatory operations team Train staff on select CMC procedures and systems Provide report status of activities and projects to teams and department Participate in cross-functional special project teams Basic Qualifications: Master's degree OR Bachelor's degree and 2 years of Pharmaceutical/Biotech and/or Healthcare and/or Med Device and/or Scientific experience OR Associate's degree and 6 years of Pharmaceutical/Biotech and/or Healthcare and/or Med Device and/or Scientific experience OR High school diploma / GED and 8 years of Pharmaceutical/Biotech and/or Healthcare and/or Med Device and/or Scientific experience Preferred Qualifications: BS degree in Life Science Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development Regulatory CMC specific knowledge and experience Developed project management and organizational skills Strong and effective oral and written communication skills Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.