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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.

About Allogene Therapeutics, Inc:Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of off-the-shelf CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit , and on Twitter and LinkedIn.Job Description:Allogene is looking for a seasoned, broadly trained scientist and manager to oversee the external quality Control (QC) testing laboratory operations supporting the CAR T products clinical and commercial manufacturing. Allogene plans to create an outstanding product design, characterization and qualification capability in the allogeneic cell therapy space. The candidate will support the QC organization in ensuring the readiness of QC contract testing laboratories (CTL) for the seamless execution of release and stability testing within agreed upon timeline to meet clinical demands according to plan and budget. The candidate will support the QC head and partner with External Quality Assurance (QA), as well as external partners in defining laboratory systems and processes for the compliant operation of this external QC laboratory network, defining and tracking key performance indicators, and resolving issues as they arise. The candidate will maintain strong connections with the internal Allogene QC laboratories ensuring alignment on requirements for methods, critical reagents, and instruments as needed. The role will entail operating in a fast-paced, highly dynamic environment with company work partnerships including both internal and external stakeholders. This role will report to the Head of QC.Responsibilities include, but are not limited to: Provides leadership, management and technical oversight for the successful execution of release and stability testing at various CTL within agreed upon turnaround-time (TAT) and within budget. Responsible for the review of CTL data, ensuring that they are maintained in compliance with regulatory and Allogenes requirements. Coordinates with Allogene laboratory heads and CTL the maintenance and management of critical laboratory reagents, standards and controls ensuring uninterrupted operation. Establishes processes to trend methods performance at CTL over time. Align with internal Allogene laboratories on control materials and performance as needed. Ensures, where applicable, alignment on instrument requirements/equivalency between Allogene and CTL. Keeps current with revisions to test methods at Allogene and CTL. Where applicable, revises methods and related documentation per established change management procedures at Allogene and CTL. Aligns and coordinates with stability manager on stability samples testing to ensure timely execution and adherence to stability studies schedules. Manages performance of CTL by tracking and ensuring established KPI are met. Escalates CTL performance issues to management in a timely manner. Actively manage CTL associated costs and ensure compliance with budget goals. Oversees validation/verification of methods for CAR T products and raw materials at CTL ensuring compliance with regulatory requirements. Provides direction and guidance to authors of method validations/verifications protocols and reports and evaluate data generated from these activities. Investigates and oversees validation exception reports where needed. In collaboration with Allogene laboratory heads and Head of Infrastructure Support and Methods Life Cycle, oversees technical transfer of CAR T and raw materials methods to and from CTL in line with regulatory requirements and per project timeline and budget. Establishes new and improves existing processes for transfer ensuring cross functional alignment with stakeholders across sites Provides technical guidance and management support for testing related nonconformance events, associated corrective and preventative actions and change control. Collaborates effectively with Allogene External QA to manage the initiation, evaluation, and closure of nonconformance events and CAPA implementation plans at CTL. Investigates unexpected/Out of Specification/Out of Trend test results. Helps define investigation/re-test plans, where applicable. Collaborates effectively with Allogenes and the CTLs QA representatives to manage the initiation, investigation, and compliant closure of these events. Authors and reviews technical registration documents and other sections of regulatory submissions pertaining to methods executed at CTL. Supports Allogene inspections and audits at CTL sites as well as internal Allogene regulatory inspections as the CTL liaison. Supports external QA in ensuring CTL are ready for GMP and pre-approval inspections (PAI). Collaborates cross functionally and builds relationships with external CTL and within Allogene QC, QA, Regulatory Affairs, Development, Manufacturing and Supply Chain to meet target milestones. Be able to negotiate, influence, and work in a matrix environment and across sites. Manages multiple projects, set priorities, and work in a fast-paced environment. Able to negotiate, influence, and work in a matrix environment. Other duties as assignedPosition Requirements & Experience: M.S./B.S. Degree, Ph.D. is a plus. Minimum 6-8 years of analytical development/QC laboratory experience in biotechnology with 2-4 years in a management role. Experience with analytical and biochemical methods including but not limited to cell-based assays/techniques including FACS analysis, potency testing, and immunofluorescence, molecular biology methodologies including but not limited to DNA, RNA manipulation and PCR, ELISA/HTRF, as well as electrophoresis/western blot analysis. Experience with HPLC systems is a plus. Experience with microbiological tests including compendial sterility testing, mycoplasma, endotoxin and viral testing. Strong understanding of GMP requirements and QC systems Experience with method development, validation and transfer Experience in dealing with regulatory agencies, supporting GMP and PAI inspections as well as experience with regulatory filings. Strong leadership ability, interpersonal, communication, and influencing skills required. Highly collaborative with the proven ability to work in a cross-functional team. Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines. Ability to work independently and as part of a team. Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment. Expected to travel 15-20% of time. Candidates must be authorized to work in the U.S. Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonablyAs an equal opportunity employer, Allogene Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.#LI-EL1

Adagene is seeking a Director or Sr. Director of Analytical to lead analytical and characterization function. This position reports to Chief Manufacturing Officer. The title of the position will depend on the qualification and experience of the candidate. The candidate should be an expert in biological product development through commercialization with hands on experience of method development and validation. In addition to the candidate is expected to have the experience in all analytical related BLA enable studies such as analytical method validation, comparability, elucidation of structure, impurity characterization and justification of specification. The candidate should have strong technical, communication and interpersonal skills. The candidate will collaborate with other functional leaders from Bioprocess, Formulation, Supply Chain, CMO management and Quality in support of the project teams and of the organization. Responsibility Lead and support analytical method development and validation at CMO facilities Define and develop physiochemical and functional assays to support process and product development as well as product release. Manage and supervise analytical experimental design, execution and writing testing methods and validation protocols/reports. Works closely with colleagues in bioprocess to ensure timely analytical support for cell line, process and formulation development. Oversee comparability strategies and CQA assessments Work with QA and CMC function leads to establish product specifications. Review and approve CMO qualification/validation protocols and reports Participating deviation investigation and CAPA establishment; address testing related issues at CMO's in collaboration with Quality. Manage reference standards and oversee critical reagent strategy. Responsible for design, plan and execute all analytical related BLA enable studies. Collaborate with QA and Regulatory to support batch releases and regulatory submissions. Requirements Ph.D. degree in analytical chemistry, biochemistry or related relevant field and 8+ years of relevant industry experience or BS/MS degree and 10+ years of biological analytical method development & validation experience. Significant experience with protein characterization and comparability assessment is essential. Direct experiences on transfer of analytical methods to CMO's is required. Experiences with method validation, process validation and BLA submission is strongly preferred Knowledge of cGMP's, regulatory guidelines, validation practices, and other relevant regulatory requirements. The position can be US or China location (may require traveling to China for US based)

Vaxcyte, Inc. (Nasdaq: PCVX) is a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent some of the most common and deadly infectious diseases worldwide. Our exclusively licensed cell-free protein synthesis platform and our proprietary know how enable us to design and produce optimized protein carriers and antigens, the critical building blocks of vaccines, in ways that we believe conventional vaccine technologies cannot. Our pipeline includes pneumococcal conjugate vaccine, or PCV, candidates that we believe are the most broad-spectrum PCV candidates currently in development, targeting the $7 billion global pneumococcal vaccine market. Our lead vaccine candidate, VAX-24, is a preclinical, 24-valent broad-spectrum pneumococcal conjugate PCV with preclinical proof-of- concept demonstrating potential to replace the standard of care that we expect to advance into clinical trials in the second half of 2021. Our pipeline also includes VAX-XP, a PCV with an expanded breadth of strain coverage, including newly emerging strains responsible for invasive pneumococcal disease and antibiotic resistance; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; and VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease by targeting the keystone pathogen responsible for this chronic, oral inflammatory disease. We completed our initial public offering in June 2020, raising $287.5 million in gross proceeds. Summary: Vaxcyte is looking for an energetic and talented individual to join the Formulation and Drug Product Development team. The primary responsibility for the incumbent will be to support the late stage activities of the Drug Product (DP) team in readiness for phase 3 clinical studies and through commercial launch. Due to the number of antigens and the suspended adjuvant system, this is arguably one of the most complex Drug Products in clinical development, so it is an incredible opportunity for the right candidate to make a significant impact on the product, the company, and the industry. This is a senior position and will require the candidate to have a high level of independence, scientific judgement, and leadership abilities. Essential Activities: • Evaluate, select, and oversee an appropriate fill finish CMO service provider to support early, late, and commercial stage manufacturing deliverables • In concert with the CMC team, design and oversee late-stage process characterization and process validation strategies consistent with CMC-regulatory guidance • Provide engineering leadership to generate the appropriate solutions for successful commercial mixing of the DP intermediates that allows compounding of 24 Drug Substances (DS) • Generation, testing, and validation of scalable mixing solutions of the DP bulk suspension mixture to ensure adequate homogeneity during the DP final fill. • Downscale of the above engineering solutions, where appropriate and possible, for utilization and facilitation of internal development work • Facilitate cross-functional process risk analysis using appropriate tools such as FMEA, leading to the identification of CPPs and CQAs • Establish supply chain logistics for the shipping of DS/intermediates/DP bulk under liquid or frozen conditions with suitable container closure systems Requirements: • BSc or MSc in Chemical Engineering, Process Engineering, Pharmaceutical Development preferred, with >15 year of industrial experience; or PhD with >10 years. • Experience in late-stage clinical manufacturing within fill finish sites under GMP regulations; it is mandatory that the successful candidate be entirely conversant with GMP manufacturing • Direct experience of chemical engineering in the biological manufacturing space, leading to custom engineering solutions • Experience in the progression of such engineering solutions from early to late clinical stage and through commercial launch, preferably in the fill/finish arena • Experience in the development of scaleup/down models and how they pertain to mixing of DP bulk, preferably suspension systems • Experience in validation of DP processes, including the use of QbD as required • Experience in leading the evaluation, selection and oversight of CMOs that perform DP fill finish activities • An understanding of the design and management of logistical supply chains to enable bespoke fill finish activities • Strong interpersonal and leadership skills; ability to communicate effectively both verbally and in written formats • Ability to work within in a fast-paced, cross functional environment, multitasking as needed Reports to: Director of Formulation and Drug Product Development Location: Foster City, CA Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.

We are currently looking to fill a Director Quality Assurance position. This position will provide professional expertise and leadership in the Quality function as it relates to Quality Control Laboratory Oversight. The individual will proactively identify and lead all aspects of implementation of industry standard methodologies for GMP across the quality control operations. Such efforts are related to assay transfers (internal and external), comparability protocols for assays, investigation assistance, trend review, specification setting, data integrity assurance practices for lab information and on the floor laboratory oversight support. There will be heavy involvement with key leaders to gain alignment for continuous improvement and relationship building. Individual will play a major role in ensuring the stability of the commercial operation while remaining adaptable to the changing needs of the clinical programs. In this role, a typical day might include the following: • Leading and developing a team of individuals in alignment with Regeneron and department objectives • Development of the QC oversight function that will assist in the strengthening of performance in the QC operations including, but not limited to: product transfers (from development to qualified/validated status), stability protocols and comparability protocols for assays • Interacting with critical management members to identify gaps and improvement measures for the QC laboratories to ensure a successful compliance profile • Assisting in revising respective assay SOPs for succinctness and clarity resulting in improvement of consistency in practices and procedures, with the objective of improving robustness and compliance and reducing ambiguity • Assisting in sophisticated investigations and identification of CAPA to deter recurrence • Providing support and preparation related to site inspections from regulatory agencies and partners • Partnering with critical contract laboratories to resolve compliance issues in clinical and commercial operations, collaborating with customer/partner quality organizations, and assisting with third-party contractor and supplier quality agreements This role might be for you if you: • Can communicate effectively and successfully handle conflict resolution • Have prior experience in a managerial capacity within QA or QC • Possess experience with laboratory operations, analytical transfer and validation, Pre-Approval Inspections, and product launch activities • Exhibit a solid understanding of KT investigation model, Root Cause Analysis (RCA), Hazard Analysis and Critical Control Point (HACCP) • Maintain current knowledge and/or experience with QA systems such as change control, investigations (laboratory), deviations, CAPA, document management systems • Are knowledgeable in Kaizen processes, six sigma, continuous improvement To be considered for this role you must hold a Bachelor's degree in Life Sciences with 10+ years of experience in the pharmaceutical/biotechnology industry for Associate Director level, 12+ years for Director level, 15+ years for Senior/Executive Director level. May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role. Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need. #LI-DF1

Vaxcyte, Inc. (Nasdaq: PCVX) is a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent some of the most common and deadly infectious diseases worldwide. Our exclusively licensed cell-free protein synthesis platform and our proprietary know how enable us to design and produce optimized protein carriers and antigens, the critical building blocks of vaccines, in ways that we believe conventional vaccine technologies cannot. Our pipeline includes pneumococcal conjugate vaccine, or PCV, candidate s that we believe are the most broad-spectrum PCV candidates currently in development, targeting the $7 billion global pneumococcal vaccine market. Our lead vaccine candidate, VAX-24, is a preclinical, 24-valent broad-spectrum pneumococcal conjugate PCV with preclinical proof-of- concept demonstrating potential to replace the standard of care that we expect to advance into clinical trials in the second half of 2021. Our pipeline also includes VAX-XP, a PCV with an expanded breadth of coverage of at least 30 strains, including newly emerging strains responsible for invasive pneumococcal disease and antibiotic resistance; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; and VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease by targeting the keystone pathogen responsible for this chronic, oral inflammatory disease. We completed our initial public offering in June 2020, raising $287.5 million in gross proceeds. Summary: We are looking for a Senior Engineer with late-stage clinical or commercial experience in manufacturing, process characterization, and process validation of biologics. The successful candidate must have the ability to work in a highly collaborative manner with both internal teams and our CMO. We are looking for an outstanding team player with excellent communication skills. The Senior Engineer will work collaboratively with the process development team responsible for early-stage bioconjugation development and Phase 1 process optimization. The Senior Engineer will be directly responsible for defining an inventive process characterization strategy for a multivalent vaccine program, and will play a critical role in overseeing process validation and implementation of a process control strategy at the commercial facility to support BLA filing and commercial launch. The candidate should have demonstrated experience with risk assessments, FMEA and identifying critical and non-critical performance parameters. Depending on experience, involvement in the design or selection of a commercial launch facility with the CMC and PD leadership is likely. This is a great opportunity to make an impact and interact cross-functionally to take Vaxcyte's lead program to the next level toward the company's first licensure application. Essential Functions: • Perform and facilitate completion of process design and characterization deliverables required for commercial manufacture of multiple drug substances. • Contribute to assessing internal or external options to complete Process Characterization and validation in a timely manner with an economy of resources and materials. • Support late stage process validation activities (including PPQ) at CMO(s) or Vaxcyte owned facility. • Facilitate and lead process risk assessments to drive process control strategies and help prioritize characterization experiments. • Independently or cooperatively design and execute studies supporting process characterization and validation. • Write and contribute to process characterization, scale-up, process control and process validation documents including strategy documents, test plans and protocols, control and process descriptions, plan summaries, SOPs. Contribute to authoring related sections to support regulatory filings. • Work with internal Process Development, Analytical Development and CMC and QA leadership and CMO's process development and GMP manufacturing team members to ensure a robust, scalable production process. Requirements: • PhD or MS degree in biochemical, chemical, or biomedical engineering with 6-8 years of relevant experience. Bachelor's degree with appreciable experience (8-12 years) will be considered as well. • Working knowledge of US FDA CFRs and European EMA, including ICH regulations • In-depth knowledge of equipment, operations, and engineering principles involved in biologics GMP manufacturing • Must have strong engineering, statistical, or scientific knowledge appropriate for job requirements. Experience with risk assessment exercises, FMEA or RAMM is required. • Experience in protein downstream purification. • Experience with Tangential Flow Filtration development is highly desirable. • Experience with manufacturing of bioconjugates (ADCs, protein conjugates, glycoconjugates, nanoparticles) is highly desirable. • Ability to understand and keep track of regulatory expectations and industry best practices. • Process control strategy, tech transfer and process validation experience. • Ability to think outside the box and combine thoroughness and inventive approaches to complex process characterization using DoE and aspects of QbD. • Experience with biologics commercial launch highly desirable. • Excellent verbal and written communication skills. • Must have excellent organization skills and the ability to handle multiple tasks. • Highly motivated, and willingness to acquire new skills and ability to work independently as well as collaboratively in a matrix environment. • Ability to travel internationally is required (not more than an average of once per quarter) Reports to: Director, Bioconjugates Development and Manufacturing Location: Foster City, CA Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.

The Project Manager (PM) is responsible for the coordination and proactive management of ongoing active pharmaceutical ingredient (API) manufacturing campaigns for Bachem customers in the biotechnology and pharmaceutical industries. The PM reports into Group Leader or Director and liaises externally with the customers as well as internally with Bachem Sales and site-specific (Torrance or Vista, CA) Operations (QC, QA, Logistics, and Production) teams to ensure that the clients' milestones and deliverables are met. Your Tasks: Proactively and simultaneously manage multiple (5+) generic and new chemical entity (NCE) drug substance manufacturing projects at Bachem Americas for non-GMP, clinical and commercial GMP use Ensure that project deliverables and timelines are met as stipulated in customer purchase orders and agreements/contracts (Non-Disclosure Agreement, Master Supply Agreement, Quality Agreement, Developmental Agreement, Statement of Work) Once project is completed, perform closing activities such as shipping, storage, and invoicing of product Interface with project management functions at other Bachem manufacturing sites (Vista, CA and Bubendorf, Switzerland) to track progress of projects ordered within the Americas Consistently communicate timely and project progress updates and/or issues to customers via email and teleconferences Effectively manage customer review, approval and delivery (where applicable) of manufacturing-related documents (batch records, analytical method and validation protocols/reports, CofA's, and release specifications) Facilitate in project-related discussions both internally and externally and generate meeting notes and action items Serve as liaison between customer contacts and technical staff at Bachem manufacturing sites Provide feedback internally on project-related proposal requests as needed Update Enterprise Resource Planning (ERP) and CRM software to reflect real-time project status/requirements Schedule, organize, and document customer visits (technical and quality/audit-related) to manufacturing sites Collaborate with Contract Manager to ensure the feasibility of compliance within all contracts and agreements Maintain close communication with Sales Team to ensure they are kept informed on project interactions with customers Communicate monthly project status, closing, and financials to Bachem upper management Participate in sales process whenever needed Assist/train sales force and other key personnel in manufacturing capabilities and associated services Special projects will be assigned on occasion Travel may be required as business demands dictate Your Profile: Minimum B.S. in Science (Chemistry, Biochemistry, Biology or similar) field 3-5 years pharm/biotech experience (laboratory, laboratory-related, and/or cGMP manufacturing) 1-3 years of project management experience 1-2 years in customer-facing role, such as Sales, consulting, or Project Management in the pharma, biotech or medical device industry Ability to understand financial aspects of customer accounts (Payment terms, pre-payment requirements, forecasting) Excellent computer/system skills, especially MS Office, CRM (Salesforce), Document Control (Master Control), Document-sharing (SharePoint, ShareFile), ERP (SAP), Online and video-conferencing meetings (Skype); MS Project Excellent written and oral communication skills Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Experience facilitating external and internal team calls and onsite visits to manufacturing sites and capturing required notes and action items Ability to communicate in a proactive and solution-focused manner, including keeping management and stakeholders aware of potential issues Detail oriented with the ability to troubleshoot and resolve problems Ability to work independently and manage one's time Communicate effectively and ability to function well in a cross-functional team environment Preferred: M.S. or Ph.D. in Science (Chemistry, Biochemistry, Biology, Bioengineering, or similar) field or MBA PMP certification Drug substance peptide, small molecule, oligonucleotide, or recombinant protein manufacturing experience FDA and/or Global Regulatory and compliance experience CMO or CRO experience Knowledge of contracts and agreements (NDA's, Supply Agreements, Quality Agreements, Request for Proposals) to ensure they are adhered to during project execution Knowledge of Chemistry, Manufacturing, and Controls (CMC) documents having to do with IND and NDA filings and API development Knowledge of packaging and shipping of drug substances domestically and/or internationally and associated Incoterms Familiarity with drug substance characterization analysis (HPLC, UPLC, LC-MS, MS, GC-MS, AAA, CHN) for in-process, release, and stability testing Nearest Major Market: Los Angeles

ASSOCIATE DIRECTOR, BIOLOGICS VALIDATION Position Summary: The Associate Director co-owns and oversee global Chemistry, Manufacturing and Controls (CMC) development for GBT biologic compounds for the treatment of Sickle Cell Disease (SCD). Responsibilities will mainly focus on the development and execution of a BLA enabling GMP process characterization and process validation of a monoclonal antibody. The candidate will develop strategies and manage study execution and data generation for applicable global regulatory submissions. Deliverable expectations to include: Partner with internal resources and external CMOs to drive process characterization and validation for a monoclonal antibody program Plan, Design and execute major BLA enabling projects through sound DOE, early risk assessments and thorough itemization of applicable deliverables. Have full awareness of the potential consequences (defects and failure modes) of design parameters to established robust and reproducible processes Lead technical process characterization and validation of a monoclonal antibody including risk assessments, process characterizations, variability assessments and statistical evaluation of multiple complex parameters Company steward for obtaining the highest product quality including leading technical discussions and influencing stakeholder acceptance of critical process and quality-based decisions Responsible and accountable for monitoring process performance/process history/ technical assessments and ownership of change controls and process deviations both internally and at CMO sites Essential Duties and Responsibilities: Demonstrates in-depth knowledge of current Good Manufacturing Practices (GMPs) Proficient in Stage 1, Stage 2, Stage 3 biologics validation including; PHA, CQA, CPP, KPI, DOE OFAT, PC, PV, PPQ Excellence in breadth and depth across engineering disciplines and is recognized as a subject matter expert for bio process development, characterization, and validation Strong biologics process characterization and validation, preferably with Monoclonal antibodies; Process Specific SME Significant experience and contribution to generation of relevant regulatory sections of BLA and MAA filings, data capture and management, process monitoring and trending, including control charting and statistical process control, and supporting regulatory and site inspections Extensive experience with Upstream and Downstream operations from thaw through DS. DP experience a plus. In-depth understanding of cell culture scale-up, engineering principles, and associated equipment - i.e. cell growth rates, nutrient consumption, gas transfers and velocities, titers and production rates General knowledge of the workstreams in the development of monoclonal antibodies; upstream and downstream processing preferred. Formulation, drug substance and drug product development, molecule characterization, analytical development, and stability testing Strong individual contributor. Must be able to work in a fast paced, multi-project and changing environment with ability to manage multiple competing responsibilities with a high degree of independence and self-motivation Outstanding written and verbal communication skills Strong organization and time management skills Team Player. Ability to thrive in flat organizational structure with strong cross functional communications and contributions. The team output is greater than the sum of the parts. This Lean team depends on everyone working together for the common goals Partner with Cross functional teammates from Tech Ops, Analytical, Quality Assurance, Regulatory, and Clinical Operations Qualifications: B.S./M.S./PhD. in Pharmaceutical Sciences, Chemical Engineering, Bioengineering, or related field with extensive experience in biotech or pharmaceuticals industry 10+ years of relevant experience in the pharmaceutical industry and a BS or BA 8+ years of relevant experience and a MS 7+ years of relevant experience and a PhD in a relevant scientific discipline Relevant industry experience in development of monoclonal antibodies or biologics platform modalities (5-8 years). Position level will be commensurate with education level and previous industrial experience Biologics Process Engineering, MSAT, Technical Services SME Demonstrates excellent verbal, technical writing, and interpersonal communication skills Has proven analytical and conceptual skills Demonstrates ability to effectively manage multiple projects/priorities Fit with GBT culture: Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.

Vaxcyte, Inc. (Nasdaq: PCVX) is a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent some of the most common and deadly infectious diseases worldwide. Our exclusively licensed cell-free protein synthesis platform and our proprietary know how enable us to design and produce optimized protein carriers and antigens, the critical building blocks of vaccines, in ways that we believe conventional vaccine technologies cannot. Our pipeline includes pneumococcal conjugate vaccine, or PCV, candidates that we believe are the most broad-spectrum PCV candidates currently in development, targeting the $7 billion global pneumococcal vaccine market. Our lead vaccine candidate, VAX-24, is a preclinical, 24-valent broad-spectrum pneumococcal conjugate PCV with preclinical proof-of- concept demonstrating potential to replace the standard of care that we expect to advance into clinical trials in the second half of 2021. Our pipeline also includes VAX-XP, a PCV with an expanded breadth of strain coverage, including newly emerging strains responsible for invasive pneumococcal disease and antibiotic resistance; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; and VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease by targeting the keystone pathogen responsible for this chronic, oral inflammatory disease. We completed our initial public offering in June 2020, raising $287.5 million in gross proceeds. Summary: Vaxcyte is looking for an energetic and talented individual to join the Formulation and Drug Product Development team. The primary responsibility for the incumbent will be to support the late stage activities of the Drug Product (DP) team in readiness for phase 3 clinical studies and through commercial launch. Due to the number of antigens and the suspended adjuvant system, this is arguably one of the most complex Drug Products in clinical development, so it is an incredible opportunity for the right candidate to make a significant impact on the product, the company, and the industry. This is a senior position and will require the candidate to have a high level of independence, scientific judgement, and leadership abilities. Essential Activities: • Evaluate, select, and oversee an appropriate fill finish CMO service provider to support early, late, and commercial stage manufacturing deliverables • In concert with the CMC team, design and oversee late-stage process characterization and process validation strategies consistent with CMC-regulatory guidance • Provide engineering leadership to generate the appropriate solutions for successful commercial mixing of the DP intermediates that allows compounding of 24 Drug Substances (DS) • Generation, testing, and validation of scalable mixing solutions of the DP bulk suspension mixture to ensure adequate homogeneity during the DP final fill. • Downscale of the above engineering solutions, where appropriate and possible, for utilization and facilitation of internal development work • Facilitate cross-functional process risk analysis using appropriate tools such as FMEA, leading to the identification of CPPs and CQAs • Establish supply chain logistics for the shipping of DS/intermediates/DP bulk under liquid or frozen conditions with suitable container closure systems Requirements: • BSc or MSc in Chemical Engineering, Process Engineering, Pharmaceutical Development preferred, with >15 year of industrial experience; or PhD with >10 years. • Experience in late-stage clinical manufacturing within fill finish sites under GMP regulations; it is mandatory that the successful candidate be entirely conversant with GMP manufacturing • Direct experience of chemical engineering in the biological manufacturing space, leading to custom engineering solutions • Experience in the progression of such engineering solutions from early to late clinical stage and through commercial launch, preferably in the fill/finish arena • Experience in the development of scaleup/down models and how they pertain to mixing of DP bulk, preferably suspension systems • Experience in validation of DP processes, including the use of QbD as required • Experience in leading the evaluation, selection and oversight of CMOs that perform DP fill finish activities • An understanding of the design and management of logistical supply chains to enable bespoke fill finish activities • Strong interpersonal and leadership skills; ability to communicate effectively both verbally and in written formats • Ability to work within in a fast-paced, cross functional environment, multitasking as needed Reports to: Director of Formulation and Drug Product Development Location: Foster City, CA Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.

Lundbeck Seattle BioPharmaceuticals (Lu-SBP), located in Bothell, Washington, is the Process Development Center of Excellence for Biologics within the global Lundbeck CMC organization. Since integrating into Lundbeck in October 2019, Lu-SBP has supported commercial launch of Lundbeck's first biologic product (Vyepti) and advancement of a growing biologics pipeline in collaboration with our Copenhagen-based Late-Stage Development and Production groups. The Lu-SBP team leads and supports the development of new product candidates from cell line development through commercial validation of Drug Substance and Drug Product manufacturing processes. At Lundbeck, we are tirelessly dedicated to restoring brain health so every person can be their best. Headquartered in Copenhagen, Denmark, and with sites in more than 50 countries, Lundbeck is the only global biopharmaceutical company focused solely on treating brain diseases. Our legacy in neuroscience and heritage of innovation spans more than seven decades and has resulted in the discovery, development and commercialization of some of the world's most widely prescribed therapies for psychiatric and neurological disorders. Today, we remain uncompromisingly committed to improving the quality of life for people impacted by brain disorders. SUMMARY: Responsible for leading Formulation Development, Drug Product development, Technology Transfer and Clinical Manufacturing Oversight for biologically derived therapeutics at Lundbeck under cGLP and cGMP guidelines. ESSENTIAL FUNCTIONS: Leads the development of stable formulations (liquid and/or lyophilized) for antibodies. Oversees the preparation of technical reports, data summaries and CMC related documents required for various regulatory submissions. Oversees the development of technical transfer protocols and supervises the development and transfer of drug product manufacturing processes into cGMP drug product manufacturing facilities. Participates in vendor selection process supporting Drug Product Manufacturing at CMOs for clinical and commercial programs. Responsible for the technical management of third-party drug product manufacturers. Provides technical oversight for clinical manufacturing activities. Provide technical support for commercial manufacturing activities. Work closely with Analytical, Bioassay, QC and QA partners to assess product quality and product stability. Represent the Drug Product group on CMC Focus Teams and Working Groups Provide organizational leadership in all areas related to formulation, fill & finish work Work collaboratively and cross-functionally with other key leaders to execute on organizational goals. Assign resources according to priority and project needs. Represent the Drug Product group to senior management and All Hands Meetings on a regular basis. REQUIRED EDUCATION, EXPERIENCE and SKILLS: Accredited Bachelor's degree and 15+ years of experience in the biopharma industry OR Accredited Master's degree with 12+ years of experience in the biopharma industry OR PhD with 10+ years of experience in the biopharma industry Extensive prior experience in the process development and clinical or commercial cGMP production of antibody or antibody-related products. Extensive experience with formulation development for liquid, frozen and lyophilized drug products and intermediates, from study design to analytical evaluation. Strong familiarity of the collection of analytical techniques that support the formulation, fill/finish process development work. Experience supporting Fill-Finish Process Development, technology transfer and manufacturing oversight of Drug Product CMO partners Excellent written and oral communication, including experience delivering professional internal and external presentations. Demonstrated experience authoring protocols, reports and regulatory filings. Fluency in the regulatory guidance documents that touch upon drug product fill/finish and stability requirements. Strong working knowledge of cGMPs and compliance requirements. Prior experience interacting with the FDA during inspections. PREFERRED EDUCATION, EXPERIENCE AND SKILLS: PhD in biology or chemistry-related disciplines and 10+ years industry experience Experience with Pre-Filled Syringe and Autoinjector development is strongly desired TRAVEL Willingness/Ability to travel up to 20% domestically and internationally Lundbeck is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify. .buttontextcc992ff0ed1a3b04 a{ border: 1px solid transparent; } .buttontextcc992ff0ed1a3b04 a:focus{ border: 1px dashed #a5a07b !important; outline: none !important; } Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best. Millions of people worldwide live with brain diseases, and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement, and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain diseases - we call this Progress in Mind. Read more at Our approximately 5,800 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing, and sales. Our pipeline consists of several R&D programs, and our products are available in more than 100 countries. We have research centers in Denmark and the US, and our production facilities are located in Denmark, France, and Italy. Lundbeck generated revenue of DKK 17 billion in 2019 (EUR 2.3 billion; USD 2.6 billion). For additional information, we encourage you to visit our corporate site , and connect with us on Twitter and via LinkedIn.

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. PROJECT SPECIALIST Under the direction of the MSAT Director, the project specialist position will create and manage complex technical projects supporting process development, continuous improvement/efficiency, deviations, CAPAs, and change controls. The position will manage projects ensuring milestones, requirements, and escalation/communication are identified and resolved as required to accomplish department, site, and corporate goals. The ability to provide hands execution in some cases will be required (set up and operation of systems, utilizing plant automation systems to obtain data). These activities will require a detailed understanding of not only the unit operations required to successfully produce product but quality principles and procedures. They will also support Manufacturing Technology quality systems (deviations, CAPAs, and change controls), collect and analyze data, write and revise procedures and protocols, collaborate with other departments on commissioning and qualification activities, use GDP and GLP, and have an interest in further developing operational skills to perform a variety of activities. Essential Functions Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Under the direction of the MSAT Director, the project specialist will: • Create and implement project plans • Proactively identify, assess, and appropriately manage risks • Apply project management best practices through the execution of all project phases to include supporting the acquisition of new process systems • Manage data as required in support of organization projects and standards. This will include statistical treatment and interpretation. • Support both existing and new site mission and objectives to include ACAM2000® smallpox vaccine production and CDMO related activities • Support site QA during audits and regulatory inspections • Collaborating with Engineering, Facilities, CQV (Commissioning, Qualification, and Validation), Manufacturing, and vendors for commissioning and qualification of new/upgraded pilot equipment • Write and revise project plans, protocols, reports, and other documents as required • Maintain qualifications for site training requirements and demonstrate quality and safety for all operational activities. • Support manufacturing, engineering, validation, quality process teams at the site and corporation to achieve goals. This may include travel to other EBSI sites. Minimum Education, Experience, Skills Requirements • BS in Bioengineering, Biology or related field and/or a minimum 1-3 years related industrial experience • Knowledge and experience in biologics development and CGMP manufacturing for biologics and vaccines • Mechanical aptitude and experience with the equipment lifecycle (Design qualification, URS, Fabrication, FAT/SAT through commissioning • Experience with Adeno-associated viral vector production and purification • Knowledge of the principles of statistical analysis, data interpretation and management • Technical writing - the ability to create concise and complete documents • A knowledge of the principles of operational excellence is desirable • Basic skills and fluency in Microsoft Word, Excel, PowerPoint, and Project Skills • Strong interpersonal, time management, laboratory, and computer skills • Science based approach and commitment to integrity • Demonstrates success in commitment, accountability, and technical proficiency • Creative, critical thinking and collaboration skills with diverse groups with others • Decision making and exercising judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. • Ensures cross-functional alignment and communication of issues and strategies. Interested? Please visit emergentbiosolutions.com and apply under the career section today! There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency. .buttontextde38d a{ border: 1px solid transparent; } .buttontextde38d a:focus{ border: 1px dashed #c11d4b !important; outline: none !important; }

The Director, Head of Analytical Sciences and Technology (AS&T) will be part of the CMC Technical Operations leadership team and a key member of the wider CMC organization. The incumbent will work cross functionally to support the successful development and manufacture of Precision BioSciences Cell and Gene Therapy Products. This is a highly visible role within Precision BioSciences as well as with external partners and will be influential in the strategic and tactical leadership of the Technical Operations organization. The Director, Head of AS&T will be responsible for leading the AS&T function in the development and execution of analytical testing strategies to support the manufacture of allogeneic CAR T and AAV gene therapy products. Responsibilities include oversight of analytical testing at external contract laboratories and contract manufacturers, development and implementation of stability strategies for the allogeneic CAR-T, AAV, and mRNA platforms, management of the critical reagent program, and implementation of data analytics approaches for tracking and trending product quality and method performance. The successful candidate will also provide leadership in defining the analytical strategy and development of plans to support late-stage and commercial readiness. The Head of AS&T will work cross-functionally with Quality Control, Quality Assurance, Regulatory Affairs, and Analytical Development functions to establish state of the art and robust analytical approaches that comply with regulatory expectations and relevant quality guidelines. This role will also work closely with the Head of MS&T and the Head of Manufacturing to support implementation of appropriate analytical control strategies for new programs and optimized manufacturing processes. The Head of AS&T will also lead/support establishment of specifications, product comparability studies, and technical investigations. Additionally, the success candidate will provide technical and strategic input and support for the preparation of regulatory submissions and health authority interactions. Essential Duties and Responsibilities Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document. Provide oversight of external testing laboratory activities including management of analytical testing, data review, troubleshooting, method improvement, generation of reports, and technical support; support external technology transfers as needed Develop and implement a GMP-compliant Stability Program for Precision BioSciences Cell and Gene Therapy products, and all associated key process intermediates (cell banks, plasmids, mRNA, AAV) Support or lead the development of analytical control strategies for CAR T and AAV products, and key process intermediates Implement and manage an analytical data tracking and trending program to monitor product quality, stability, and method performance Develop and maintain an effective program to manage Critical Reagents and Reference Standards to ensure compliant and consistent product quality testing Work cross-functionally to define a stage-appropriate control strategy for Infectious Disease Testing (IDT) for allogeneic CAR T products Support development of phase-appropriate method validation approaches for release and characterization testing Support or lead the Specification Team to establish, review, update and maintain product specifications for CAR T and AAV products as well as for key process intermediates Author/Review study protocols, reports, SOPs, investigations, change controls, and method development/qualification reports Author/Review regulatory submissions (IND, briefing packages, responses to questions) and provide strategic and technical support for interactions with health authorities Develop short- and long-term strategic plans for the AS&T function that are aligned with Precisions plans to support development and commercialization of its products Set strategic objectives, provide clear direction, and manage execution for the AS&T function Responsible for organizational design and staffing decisions for the AS&T function. Recruit, retain, train and develop team members Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve Interface with external partners and internal QA and QC groups to support review of data, lab investigations, change controls, etc. Remain current with regulatory and industry requirements relevant to analytical testing, specifications, and stability programs for cell and gene therapy products to support clinical development and commercial registration Qualifications The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully. Required: PhD in Biochemistry, Biology, or related field and 10+ years of experience in the biotechnology/pharmaceutical industry with increasing responsibility in analytical development or quality management, or equivalent combination of education and experience 7+ years of analytical management experience to support development of biological products Deep expertise in assay development, method qualification/validation, quality requirements, and regulatory expectations for testing of biological and cell & gene therapy products Experience in authoring regulatory submissions (INDs, briefing packages, BLAs) and face-to-face interactions with regulatory agencies (FDA) Expertise in leading activities to support technical investigations, deviations and change controls Demonstrated experience managing analytical testing at external contract organizations Preferred: Experience in Quality Control, Analytical Sciences and Technology, or Analytical Development in a biopharmaceutical or cell and gene therapy company Experience with gene/cell therapy products; experience with late-stage and commercialization programs strongly preferred Excellent planning, organization, prioritization, and management skills to direct the work of others on assigned projects, including internal teams and external collaborators Demonstrated ability to create and foster effective teamwork, build relationships, motivate others, work in a matrix organization, and collaborate at all organizational levels Results oriented, with a sense of urgency; strong initiative, accountability, and willingness to take ownership and drive projects to completion Comfortable with rolling up the sleeves and executing the work needed to support the success of projects in a small company environment Strong critical thinking and problem-solving skills Excellent written and verbal communication skills Experience in good documentation practices, data archiving, and statistical approaches to support data trending and stability analyses Travel Requirements This position requires some travel (10%) Location This is a primarily office-based position associated with the main headquarters in downtown Durham, NC. For the time being, this role will be able to function remotely in accordance with company safety guidelines throughout the duration of the pandemic but is subject to change as needed. Precision BioSciences, Inc. (Nasdaq: DTIL), is a clinical stage biotechnology company dedicated to improving life (DTIL) with its novel and proprietary ARCUS genome editing platform. This isnt just a statement supporting the products that were developing its a statement that speaks to our collective desire to do our part in improving the lives of those around us. ARCUS is a highly specific and versatile genome editing platform designed with therapeutic safety, delivery, and control in mind. Using ARCUS, Precision is developing allogeneic CAR T and in vivo gene correction therapies for cancer and genetic diseases. Our team includes pioneers in genome editing, leaders in business, and a full staff of talented and committed people who are excited to be a part of medical and scientific breakthroughs. For additional information, please visit www. precisionbiosciences.com Precision BioSciences actively fosters an inclusive environment to ensure we attract and retain the best talent; we value diversity of life experiences and perspectives; and we encourage innovation in pursuit of our mission. We provide equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Precision BioSciences complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Graphite Bio is a clinical-stage biotechnology company focused on harnessing the power of targeted DNA integration. Integral Medicines uses next-generation CRISPR based technology platforms for developing curative gene correction-based stem cell therapies for serious and life-threatening genetic diseases with inadequate existing treatment options Summary: In this role you will set the strategies for developing state of-the-art analytical technologies and control systems to deliver Graphite's Gene Therapy products. What You Will Do: Recruit and develop an expert team of analytical scientists to characterize quality gene therapy processes and products. Perform analytical method development and qualification, mechanism of action characterization and determination of critical quality attributes. Provide analytical support to research and process development in support of process characterization and validation Identify and understand the impact of product quality differences as the result of process changes to assure product comparability. Biological assay development (cell-based and non-cell based) in support of potency testing and product characterization, CQA assessment, process development support, comparability assessments, and potency method validation and product control system specifications. Validation and Testing: Perform clinical product QC release, stability testing, method qualification and execution of cGMP lab operations. Perform commercial method validation studies and assay transfers to QC partners internally and externally. Direct IND and BLA/MAA authoring and ensure the quality of development studies, reports and regulatory documents. Play a key role in regulatory negotiations.Develop , refine, and implement strategies, including Quality by Design concepts where appropriate, for product characterization, method development and validation, and specifications. Adhere to internal and external (ICH, GMP) requirements for analytical functions, including training, investigations, validation, and QC testing What You Will Bring: Ph.D. degree (preferably in Life Science) or equivalent work experience, and a minimum 15 years of relevant experience in the pharmaceutical or biopharmaceutical industries, including 10 years of leadership experience, and demonstrated knowledge of relevant cGMP regulations. Experience with analytical development and QC of Cell and/or Gene Therapy products strongly preferred. Demonstrated leadership with strong communication skills and an ability to deliver the results through teamwork. High learning agility with demonstrated critical thinking and problem solving skills, ability to adapt under challenging situations. Fit with Graphite Bio's culture: Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with Graphite Bios' Core Values Excitement about the vision and mission of Graphite Bio Flexibility Integrity Compensation/ Benefits: Competitive salary with equity Free on-site gym access Free on-site meals and coffee bar Health benefits Graphite Bio is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.

About CSL With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! Job Description CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients' needs by using the latest technologies, we develop and deliver innovative therapies that are used to treat people with life-threatening medical conditions and to help them live full lives. The parent company, CSL Limited, is headquartered in Melbourne, Australia. In May 2014, CSL selected Lengnau in the Canton of Bern in Switzerland as the location of a new manufacturing facility to support the commercial production of our promising novel therapies. In May 2020, CSL announced the strategic partnership with Thermo Fisher Scientific, the world leader in serving science. Thermo Fisher will lease and operate the Lengnau state-of-the-art biotech manufacturing facility once construction is completed in 2021. It is anticipated that employees at the site who are engaged for the operation of the site and the commercial production of our therapies in Lengnau will automatically transfer to Thermo Fisher Scientific once construction is complete. Today, more than 200 employees work in Lengnau. You can find more information on the strategic partnership with Thermo Fisher here and some more information about the prospects of a future career with Thermo Fisher here . We are looking for talented and dedicated personalities that share our passion to develop and deliver innovative therapies. With your commitment, reliability and high-quality standards you help us to improve the quality of life for those in need. We are currently recruiting for a Manager Engineering Services Quality Management (ESQM) Position Purpose Supporting the Lengnau (LGN) Facility Project Team ambitions of delivering a 'Right First Time' project to manufacturing operations, the main responsibilities of this position are: Providing leadership in Engineering Quality Assurance matters Managing the Lengnau Facility Project Engineering Quality Management system to ensure Quality is proactively engineered into, and assured on the project by design engineers, vendors, contractors and constructors. Developing Project Quality Management plans, Audit processes and schedules and document review processes to assure the use of Good Engineering Practices and Good Documentation Practices and trains the project community in the same. Leads the Eng. QA team Strengthens collaboration with all project team functions and members Proactively identifies resource requirements and builds teams using both CSL and external resources. Member of the Facility Project Leadership team Reporting Relationships: The role reports to/dotted line reporting to Head of Facility Project Key Interfaces Functional Heads of LGN Facility Project Team (CVQ, Quality and project managers other buildings) Construction Manager LGN PMO function Main Responsibilities and Accountabilities Technical Responsibilities Responsible for developing, receiving, approval for and maintaining the Project Quality Management System procedure, and Project Training Plan. Regular reporting of current performance of the PQMS to the Project Director Developing and maintaining the Audit Program and undertaking Quality and GDP audits as scheduled, conducting Internal CSL Quality Audits and External partner Quality Audits on Exyte, DPS, Construction Management, ANS, Vendors and subcontractors. Responsible for the leadership, performance and development of the Engineering Services Quality Management teams, incl. recruitment, supervision, engagement, coaching, development, evaluation... Responsible for establishing and facilitating a culture where Eng. QA practices are seen as key enablers for a successful project Ensure project documentation procedures and document deliverables are of an acceptable quality to support compliance to applicable standards. Approve relevant project procedures and documentation. Review and comment on general Project procedures to ensure control systems are in place with respect to activities affecting quality and documentation Ensure VTOPs are reviewed and turned over on time Engage with and support the various teams on the project (design, CM, CVQ, Safety etc.) for cross functional best practice sharing and issue resolution in regard to Compliance, Document Management and CVQ strategies and expertise. Developing Training Plans for Facility Project Team members in project procedures, Good Documentation Practice, Good Engineering Practices etc. Preparing training materials, providing and documenting training. Ensuring regular reporting of training status to Project Leadership Leadership Maintains an external and strategic focus ensuring that his/her deliverables evolve to meet customers' and stakeholders' challenges and trends and that best practices from the outside environment and industry are incorporated and deployed Acts and promotes collaboration in the work environment and operates in full alignment with the company's core values Creates and promotes an accountable working environment by providing clear guidance and expectations to stakeholders and counterparts Ensures clarity and full understanding of the site/company's department strategy by promoting an effective and timely communication in the project team and towards all involved parties Promotes and executes a KPI drive management approach Qualifications: Degree in Engineering or Science preferable Strong operational experience gained in construction, commissioning and qualification environment preferably in Life Science/Pharma/Biotech/Fill Finish facility Proven experience and knowledge in process, automation and engineering relating to pharmaceutical of Biotech facilities Proven experience in GxP (GMP, GEP, GDP), qualification and validation Organizational skills with the ability to handle multiple assignments Strong communications skills We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and copies of relevant transcripts and/or diplomas in the original language. Please include all these in one document together with the CV. CSL Behring is committed to provide equal employment opportunity for all.

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. JOB SUMMARY The Manager Manufacturing position reports to the Sr. Manager of Manufacturing at Emergent Manufacturing Operations Baltimore (EMOB). The position is responsible for manufacturing operations. This includes management of manufacturing staff, manufacturing budgets, developing standard operating procedures and training, interacting with other departments and being on-call during critical process operations. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Provides hands-on supervision of manufacturing staff in the operation of pharmaceutical manufacturing equipment such as: incubators, wave reactors, single-use bioreactors, depth filtration skids, TFF skids, chromatography skids, single-use mixers and in process testing equipment Establishes performance standards and goals for Manufacturing Supervisors and Associates Demonstrates and enforces understanding and adherence to Emergent policies, GMP standards and safety procedures Hires, evaluates, trains, develops and terminates staff Oversee development and maintenance of management processes including, but not limited to: Employee job descriptions, Integrated Performance Management Process (IPMP) documentation, staffing models, resource allocation models. Effectively delegate decision making into the department. Empower direct reports to make level-appropriate decisions. Updates the Sr. Manager of Manufacturing on process status and achievement of objectives Resolves problems of manufacturing staff and manages manufacturing resources Develops and maintains manufacturing budgets Interacts with other site group leaders including Sr. Director and VP level staff Prepares and conducts technical presentations of manufacturing processes Performs annual performance appraisals of staff reporting to the position Generate Batch Records, SOPs and Protocols as required Reviews Batch Records, SOPs and Protocols as required Verifies manufacturing readiness including raw materials, staff training, suite cleaning and equipment operation Responds to or delegate duty as primary, manufacturing alarm response representative according to site alarm response policy Works with subject matter experts to trouble-shoot and/or optimize processes as required Supports the technical transfer of new products into the manufacturing area Supports Validation, Engineering and Facilities personnel in start-up, testing and operation of manufacturing process equipment Supports Emergent QA during audits and regulatory inspections Supports other manufacturing process teams and other EMOB groups as necessary to achieve Manufacturing team goals The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. MINIMUM EDUCATION, EXPERIENCE, SKILLS BS degree in biology, chemistry or related scientific or engineering field Minimum 6 years of GMP pharmaceutical experience; Minimum 4 years supervisory experience; Hands-on experience with the installation, operation, cleaning and maintenance of pharmaceutical GMP equipment Computer literate (Word, Excel and PowerPoint) There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency. .buttontextde38d a{ border: 1px solid transparent; } .buttontextde38d a:focus{ border: 1px dashed #c11d4b !important; outline: none !important; }

Hi, We have an exciting opportunity for the role of "Associate Director, Biostatistics" with our client. Please check the job description as below and let me know your interest. In case you are not looking for any change, I'd appreciate if you could refer any friends/ colleagues who might be interested in it. Direct Hire - Associate Director, Biostatistics - Neurology Jersey city, NJ This position supports the activities/projects in the Neurology Business Group including clinical study design and analysis, publications, as well as regulatory interactions. Essential Functions Reviews protocols and other study documents that are developed in collaborations of business alliances. Provides statistical supports for regulatory submissions in the collaborations. Independently reviews whole protocol and interfaces with clinicians and other functions to understand study requirements and study design elements including sample size calculations, analysis methods, study durations etc. for multiple studies. Develops and/or reviews statistical documents for multiple clinical trials, including SAPs, TLG shells and specifications of variable derivation. Support clinical trial related publications. Independently provides statistical and validation support for analysis datasets, statistical tables, figures and listings. Performs and validates statistical analysis. Independently reviews CSRs and performs data interpretation. Works with the internal/CRO statisticians and programmers to ensure the quality of CRO deliverables and on QA of data outputs. Functions as lead statistician in global registration trials and manages all related statistical activities. Leads preparation of inputs for regulatory documents and helps to prepare for meetings with health authorities. Leads preparation of responses to health authorities including identification and execution of new analysis required for responses. Manages contract statisticians in the group. Provides mentoring and oversees assigned work. Requirements PhD with 5+ years or MS with 10+ years of experience required in related discipline or in the pharmaceutical industry/CRO environment. Demonstrated excellence in statistical skills across multiple areas of pharmaceutical biostatistics, together with broad understanding and experience of the clinical development process. Experience with CRO oversight and FDA submission preferred. Excellent technical writing and verbal communication skills. Strong teamwork ability/commitment and individual initiative. Strong organizational skills with ability to effectively manage multiple studies. Excellent programming skills in SAS or R. - provided by Dice

Direct hire, Permanent job E3389 Associate Director, Biostatistics - Neurology Salary Starting base salary range: $150,000 Bonus range: 16-20% Eisai Relocation is available for great candidates Location 100 Tice Blvd., Woodcliff Lake, NJ 07677 Highlights from Job Description and Additional Info.: • Eisai seeks pharma and biotech industry-experienced candidates. • This position will support an important lemborexant initiative for Eisai. • Preferred candidates will show a history of being promoted at their companies. • Seeking candidates with excellent interpersonal skills and who have been very well-regarded at their companies. • See the job description for additional details and requirements. Associate Director, Biostatistics - Neurology Job Summary This position supports the activities/projects in the Neurology Business Group including clinical study design and analysis, publications, as well as regulatory interactions. Essential Functions • Reviews protocols and other study documents that are developed in collaborations of business alliances. Provides statistical supports for regulatory submissions in the collaborations. • Independently reviews whole protocol and interfaces with clinicians and other functions to understand study requirements and study design elements including sample size calculations, analysis methods, study durations etc. for multiple studies. • Develops and/or reviews statistical documents for multiple clinical trials, including SAPs, TLG shells and specifications of variable derivation. Support clinical trial related publications. • Independently provides statistical and validation support for analysis datasets, statistical tables, figures and listings. Performs and validates statistical analysis. Independently reviews CSRs and performs data interpretation. • Works with the internal/CRO statisticians and programmers to ensure the quality of CRO deliverables and on QA of data outputs. • Functions as lead statistician in global registration trials and manages all related statistical activities. • Leads preparation of inputs for regulatory documents and helps to prepare for meetings with health authorities. Leads preparation of responses to health authorities including identification and execution of new analysis required for responses. • Manages contract statisticians in the group. Provides mentoring and oversees assigned work. Requirements • PhD with 5+ years or MS with 10+ years of experience required in related discipline or in the pharmaceutical industry/CRO environment. • Demonstrated excellence in statistical skills across multiple areas of pharmaceutical biostatistics, together with broad understanding and experience of the clinical development process. • Experience with CRO oversight and FDA submission preferred. • Excellent technical writing and verbal communication skills. • Strong teamwork ability/commitment and individual initiative. • Strong organizational skills with ability to effectively manage multiple studies. • Excellent programming skills in SAS or R. - provided by Dice

Overview The Sr. Manager / Associate Director of IT R&D Systems will be responsible to oversee and manage the portfolio of R&D and Manufacturing systems. She/He will work closely with IT colleagues, scientists, validation, QA, and vendors to ensure that lab systems and processes are operational and optimized to meet the needs of these groups, advise and recommend changes to systems, and ensure that changes to these systems follow company procedures, guidelines and regulations. Experience managing GMP or GLP lab systems, a solid understanding of GxP regulations, and excellent analytical, interpersonal and technical writing skills are required. This position will be based in Fall River, MA but may require occasional travel to other Celldex offices. Responsibilities Oversee and manage portfolio of R&D IT implementation/upgrade projects and the change control process in a manner that is compliant with regulatory requirements and company policies and procedures. Develop, review and update IT policies, procedures, and standards to assure regulatory compliance, data integrity, and operational efficiencies. Provide primary IT support for all lab equipment software and GxP-regulated systems (primarily GMP and GLP, but may include GPVP and ====P), e.g. system administration, troubleshooting issues, software patches. Act as liaison and collaborate with cross-functional team of internal stakeholders, IT consultants, and software vendors to make recommendations on new purchases, upgrades or updates to software or systems, and resolve system issues, while maintaining the validated state of computerized systems and data integrity. Qualifications Qualified candidate must: Have experience working in validated GMP environment Have strong understanding of GxP regulations (e.g., 21 CFR Part 11, Annex 11), computer system validation, and SDLC Possess excellent interpersonal skills, be diligent and self-motivated, with an eagerness to learn and excel in a high-paced environment Strong analytical skills with demonstrated ability to solve complex problems, resolve deviations, and make realistic recommendations and plans Strong technical writing skills and detail-oriented with the ability to thoroughly document processes, requirements, and write various technical and validation documents Knowledge of various R&D computerized systems and willingness to learn new systems Flexibility to adjust to changing priorities or timelines Be willing to travel occasionally to other office locations in MA, CT and NJ Education/Experience Experience administering or supporting software and data management of various lab systems such as HPLCs, Plate Readers, Bioreactors, ELNs 5+ years of experience working in validated environment leading computerized system validation projects in pharmaceutical or biotechnology industry Minimum of BA or BS in scientific field or Information Technology Understanding of scientific processes a plus Clean room experience a plus - provided by Dice