RELOCATION ASSISTANCE: Relocation assistance may be available CLEARANCE TYPE: Top Secret TRAVEL: Yes, 10% of the Time Description At Northrop Grumman, our employees have incredible opportunities to work on revolutionary systems that impact people's lives around the world today, and for generations to come. Our pioneering and inventive spirit has enabled us to be at the forefront of many technological advancements in our nation's history - from the first flight across the Atlantic Ocean, to stealth bombers, to landing on the moon. We look for people who have bold new ideas, courage and a pioneering spirit to join forces to invent the future, and have fun along the way. Our culture thrives on intellectual curiosity, cognitive diversity and bringing your whole self to work - and we have an insatiable drive to do what others think is impossible. Our employees are not only part of history, they're making history. Northrop Grumman Mission Systems is a trusted provider of mission-enabling solutions for global security. Our Engineering and Sciences (E&S) organization pushes the boundaries of innovation, redefines engineering capabilities, and drives advances in various sciences. Our team is chartered with providing the skills, innovative technologies to develop, design, produce and sustain optimized product lines across the sector while providing a decisive advantage to the warfighter. Come be a part of our mission! We are looking for you to join our team as a Principal / Sr. Principal Software Engineer based out of Woodland Hills, CA. As a Principal / Sr. Principal Software Engineer at Northrop Grumman, you will have a challenging and rewarding opportunity to be a part of our Enterprise-wide digital transformation. Through the use of Model-based Engineering, DevSecOps and Agile practices we continue to evolve how we deliver critical national defense products and capabilities for the warfighter. Our success is grounded in our ability to embrace change, move quickly and continuously drive innovation. The successful candidate will be collaborative, open, transparent, and team-oriented with a focus on team empowerment & shared responsibility, flexibility, continuous learning, and a culture of innovation. For this role, responsibilities include but are not limited to: Provide technical leadership for junior software engineers Develop software utilizing C/C++ to modernize and productionize a research codebase with modern C++ features Develop software infrastructure to support CI/CD, software metrics collection, and MLOps Implement software-systems, applications, and architectures that leverage techniques to support achieving increased modularity, scalability, and reliability, while also maintaining precision, accuracy, and speed to meet performance requirements Ensure industry software engineering best practices and standards are applied and maintained Work closely with Software Leads and Architects to understand program intent, system capabilities, and output requirements This requisition may be filled at a higher grade based on qualifications listed below This requisition may be filled at either a Principal Level or a Sr. Principal Level. Basic Qualifications for a Principal Software Engineer (T03) Bachelor's degree in a STEM discipline with 5+ years of relative experience; Master's degree in a STEM discipline with 3+ years of relative experience; PhD + 1 year of relative experience Active Top Secret security clearance Ability to meet customer-specific security screening requirements within a timeframe set forth by management Willingness and ability to work onsite full-time Experience working in C/C++ Familiarity with modern C++ standards and features (e.g., C++ 17 onwards) Demonstrated ability to analyze system requirements to derive software design and performance requirements Proven ability to design and code new software, as well as modify existing software to add new features Ability to debug existing software and correct defects Experience with open software/system architecture solutions Effective communication and interpersonal skills, with the ability to collaborate effectively with diverse stakeholders Experience with developing and maintaining CI/CD pipelines Experience with Git-based or other software configuration management tools Basic Qualifications for a Sr. Principal Software Engineer (T04) Bachelor's degree in a STEM discipline with 8+ years of relative experience; Master's degree in a STEM discipline with 6+ years of relative experience; PhD + 4 years of relative experience Active Top Secret security clearance Ability to meet customer-specific security screening requirements within a timeframe set forth by management Willingness and ability to work onsite full-time Experience working in C/C++ Familiarity with modern C++ standards and features (e.g., C++ 17 onwards) Demonstrated ability to analyze system requirements to derive software design and performance requirements Proven ability to design and code new software or modify existing software to add new features Ability to debug existing software and correct defects Experience with open software/system architecture solutions Effective communication and interpersonal skills, with the ability to collaborate effectively with diverse stakeholders Experience with developing and maintaining CI/CD pipelines Experience with Git-based or other software configuration management tools Preferred Qualifications Experience leading the performance of tasks on schedule, at cost and achieving specified requirements Experience with modern C++ standards and features (e.g., C++ 20 onwards) Experience with containers (Docker, Kubernetes) Experience with Linux operating systems Experience with CUDA and GPUs Experience with high performance numerical/scientific computing, parallel computing Experience with developing for SWaP-constrained environments Experience with developing and maintaining CI/CD pipelines Familiarity with signal-processing algorithms Familiarity with Agile lifecycle process including Scrum and DevSecOps Primary Level Salary Range: $114,000.00 - $171,000.00 Secondary Level Salary Range: $142,200.00 - $213,400.00 The above salary range represents a general guideline; however, Northrop Grumman considers a number of factors when determining base salary offers such as the scope and responsibilities of the position and the candidate's experience, education, skills and current market conditions. Depending on the position, employees may be eligible for overtime, shift differential, and a discretionary bonus in addition to base pay. Annual bonuses are designed to reward individual contributions as well as allow employees to share in company results. Employees in Vice President or Director positions may be eligible for Long Term Incentives. In addition, Northrop Grumman provides a variety of benefits including health insurance coverage, life and disability insurance, savings plan, Company paid holidays and paid time off (PTO) for vacation and/or personal business. The application period for the job is estimated to be 20 days from the job posting date. However, this timeline may be shortened or extended depending on business needs and the availability of qualified candidates. Northrop Grumman is an Equal Opportunity Employer, making decisions without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability, or any other protected class. For our complete EEO and pay transparency statement, please visit U.S. Citizenship is required for all positions with a government clearance and certain other restricted positions.
12/10/2025
Full time
RELOCATION ASSISTANCE: Relocation assistance may be available CLEARANCE TYPE: Top Secret TRAVEL: Yes, 10% of the Time Description At Northrop Grumman, our employees have incredible opportunities to work on revolutionary systems that impact people's lives around the world today, and for generations to come. Our pioneering and inventive spirit has enabled us to be at the forefront of many technological advancements in our nation's history - from the first flight across the Atlantic Ocean, to stealth bombers, to landing on the moon. We look for people who have bold new ideas, courage and a pioneering spirit to join forces to invent the future, and have fun along the way. Our culture thrives on intellectual curiosity, cognitive diversity and bringing your whole self to work - and we have an insatiable drive to do what others think is impossible. Our employees are not only part of history, they're making history. Northrop Grumman Mission Systems is a trusted provider of mission-enabling solutions for global security. Our Engineering and Sciences (E&S) organization pushes the boundaries of innovation, redefines engineering capabilities, and drives advances in various sciences. Our team is chartered with providing the skills, innovative technologies to develop, design, produce and sustain optimized product lines across the sector while providing a decisive advantage to the warfighter. Come be a part of our mission! We are looking for you to join our team as a Principal / Sr. Principal Software Engineer based out of Woodland Hills, CA. As a Principal / Sr. Principal Software Engineer at Northrop Grumman, you will have a challenging and rewarding opportunity to be a part of our Enterprise-wide digital transformation. Through the use of Model-based Engineering, DevSecOps and Agile practices we continue to evolve how we deliver critical national defense products and capabilities for the warfighter. Our success is grounded in our ability to embrace change, move quickly and continuously drive innovation. The successful candidate will be collaborative, open, transparent, and team-oriented with a focus on team empowerment & shared responsibility, flexibility, continuous learning, and a culture of innovation. For this role, responsibilities include but are not limited to: Provide technical leadership for junior software engineers Develop software utilizing C/C++ to modernize and productionize a research codebase with modern C++ features Develop software infrastructure to support CI/CD, software metrics collection, and MLOps Implement software-systems, applications, and architectures that leverage techniques to support achieving increased modularity, scalability, and reliability, while also maintaining precision, accuracy, and speed to meet performance requirements Ensure industry software engineering best practices and standards are applied and maintained Work closely with Software Leads and Architects to understand program intent, system capabilities, and output requirements This requisition may be filled at a higher grade based on qualifications listed below This requisition may be filled at either a Principal Level or a Sr. Principal Level. Basic Qualifications for a Principal Software Engineer (T03) Bachelor's degree in a STEM discipline with 5+ years of relative experience; Master's degree in a STEM discipline with 3+ years of relative experience; PhD + 1 year of relative experience Active Top Secret security clearance Ability to meet customer-specific security screening requirements within a timeframe set forth by management Willingness and ability to work onsite full-time Experience working in C/C++ Familiarity with modern C++ standards and features (e.g., C++ 17 onwards) Demonstrated ability to analyze system requirements to derive software design and performance requirements Proven ability to design and code new software, as well as modify existing software to add new features Ability to debug existing software and correct defects Experience with open software/system architecture solutions Effective communication and interpersonal skills, with the ability to collaborate effectively with diverse stakeholders Experience with developing and maintaining CI/CD pipelines Experience with Git-based or other software configuration management tools Basic Qualifications for a Sr. Principal Software Engineer (T04) Bachelor's degree in a STEM discipline with 8+ years of relative experience; Master's degree in a STEM discipline with 6+ years of relative experience; PhD + 4 years of relative experience Active Top Secret security clearance Ability to meet customer-specific security screening requirements within a timeframe set forth by management Willingness and ability to work onsite full-time Experience working in C/C++ Familiarity with modern C++ standards and features (e.g., C++ 17 onwards) Demonstrated ability to analyze system requirements to derive software design and performance requirements Proven ability to design and code new software or modify existing software to add new features Ability to debug existing software and correct defects Experience with open software/system architecture solutions Effective communication and interpersonal skills, with the ability to collaborate effectively with diverse stakeholders Experience with developing and maintaining CI/CD pipelines Experience with Git-based or other software configuration management tools Preferred Qualifications Experience leading the performance of tasks on schedule, at cost and achieving specified requirements Experience with modern C++ standards and features (e.g., C++ 20 onwards) Experience with containers (Docker, Kubernetes) Experience with Linux operating systems Experience with CUDA and GPUs Experience with high performance numerical/scientific computing, parallel computing Experience with developing for SWaP-constrained environments Experience with developing and maintaining CI/CD pipelines Familiarity with signal-processing algorithms Familiarity with Agile lifecycle process including Scrum and DevSecOps Primary Level Salary Range: $114,000.00 - $171,000.00 Secondary Level Salary Range: $142,200.00 - $213,400.00 The above salary range represents a general guideline; however, Northrop Grumman considers a number of factors when determining base salary offers such as the scope and responsibilities of the position and the candidate's experience, education, skills and current market conditions. Depending on the position, employees may be eligible for overtime, shift differential, and a discretionary bonus in addition to base pay. Annual bonuses are designed to reward individual contributions as well as allow employees to share in company results. Employees in Vice President or Director positions may be eligible for Long Term Incentives. In addition, Northrop Grumman provides a variety of benefits including health insurance coverage, life and disability insurance, savings plan, Company paid holidays and paid time off (PTO) for vacation and/or personal business. The application period for the job is estimated to be 20 days from the job posting date. However, this timeline may be shortened or extended depending on business needs and the availability of qualified candidates. Northrop Grumman is an Equal Opportunity Employer, making decisions without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability, or any other protected class. For our complete EEO and pay transparency statement, please visit U.S. Citizenship is required for all positions with a government clearance and certain other restricted positions.
Why USAA? At USAA, our mission is to empower our members to achieve financial security through highly competitive products, exceptional service and trusted advice. We seek to be the choice for the military community and their families. Embrace a fulfilling career at USAA, where our core values - honesty, integrity, loyalty and service - define how we treat each other and our members. Be part of what truly makes us special and impactful. The Opportunity We are seeking a dedicated Development Product Owner Senior to support our Auto Modernization Development area. This role serves as a direct representative of the business on an agile team. Attains, understands, and communicates business vision and needs in order to write and refine user stories, prioritize work, and provide guidance to technical teams. Uses critical thinking, problem solving, and Agile principles to partner with business owners, subject matter experts, and the development team to build effective solutions. Possesses an advanced knowledge and understanding of and ability to work within multiple delivery methodologies, including Agile and other approaches, to deliver business value. We offer a flexible work environment that requires an individual to be in the office 4 days per week. This position can be based in one of the following locations: San Antonio, TX or Plano, TX. Relocation assistance is not available for this position. What you'll do: Works with business and Subject Matter Experts to understand business strategy and vision and then writes, refines, accepts and prioritizes stories and/or features to support effective and compliant solutions while balancing investment and business value. Owns and maintains a prioritized work backlog for one or more Agile teams. Product backlog includes complete user stories with acceptance criteria so that they are consumable and testable by the Agile team or program. Reviews and accepts output of I/T and/or business development to ensure specified acceptance criteria have been completed. Serves as direct representative of the business with one or more delivery teams, representing the customers' perspective throughout the product delivery cycle. Participates in a cross-functional team of user experience partners, designers, business analysts, developers, testers and others to develop, implement and release in alignment with program and/or product road maps. Partners with sponsors, stakeholders, and IT to facilitate, define and document relevant business processes, gaining an advanced understanding of the needs, measures, and risks & controls for the improvement area. Prepares the business for the change and provides tactics and metrics for benefits, adoption, and risk. Leverages existing change management routines, as needed. Works with different technologies, internal and external to have oversight of development, testing and controls. Applies advanced knowledge in the business development/execution area, regularly seeking out opportunities to enhance, improve and advance the function. Coaches and mentors other Product Owners. Demonstrates advanced knowledge in multiple business or system domains and capable of leading development across multiple teams at the project or program level. Ensures risks associated with business activities are effectively identified, measured, monitored, and controlled in accordance with risk and compliance policies and procedures. What you have: Bachelor's degree; OR 4 years of related experience (in addition to the minimum years of experience required) may be substituted in lieu of degree. 6 years of experience in process improvement, project delivery, business/requirements analysis or directly related to supported business operations/product line. Advanced knowledge of Microsoft Office products, applicable databases and product management tools. Advanced knowledge of multiple technical software delivery methodologies (i.e., Agile, Waterfall, SAFe). Advanced experience analyzing business requirements, process flows and use cases to find opportunities to streamline business processes in accordance with risk management framework and regulatory requirements. Advanced knowledge and demonstrated use of Process Engineering methodologies. Advanced ability to independently work to gather business requirements, process flows and use cases to develop and deliver on business capabilities within the approved methodology, writing user stories, and following the development process through user story acceptance. Experience in analyzing business requirements and ability to find opportunities to drive decisions and streamline business processes in accordance with risk management framework and regulatory requirements. What sets you apart: 8+ years P&C Personal Lines experience (ideally Auto) 6+ years of experience specializing in Personal Lines modernization using Guidewire Policy Center and/or Duckcreek. 6+ years of experience leading agile product development, transforming legacy systems, and enhancing customer experiences. Extensive experience with Guidewire or Duckcreek Out of the Box (OOTB) Insurance Product, including Quote, Policy Processing, Rating, and Underwriting. 6+ years business analyst/development product owner experience refining and prioritizing product backlog for teams. Experience directly leading modernization efforts for a large Tier 1 insurance carrier. Guidewire Associate/Analyst Certification US military experience through military service or a military spouse/domestic partner Compensation range: The salary range for this position is: $103,450 - $197,730. Compensation: USAA has an effective process for assessing market data and establishing ranges to ensure we remain competitive. You are paid within the salary range based on your experience and market data of the position. The actual salary for this role may vary by location. Employees may be eligible for pay incentives based on overall corporate and individual performance and at the discretion of the USAA Board of Directors. The above description reflects the details considered necessary to describe the principal functions of the job and should not be construed as a detailed description of all the work requirements that may be performed in the job. Benefits: At USAA our employees enjoy best-in-class benefits to support their physical, financial, and emotional wellness. These benefits include comprehensive medical, dental and vision plans, 401(k), pension, life insurance, parental benefits, adoption assistance, paid time off program with paid holidays plus 16 paid volunteer hours, and various wellness programs. Additionally, our career path planning and continuing education assists employees with their professional goals. For more details on our outstanding benefits, visit our benefits page on Applications for this position are accepted on an ongoing basis, this posting will remain open until the position is filled. Thus, interested candidates are encouraged to apply the same day they view this posting. USAA is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
12/06/2025
Full time
Why USAA? At USAA, our mission is to empower our members to achieve financial security through highly competitive products, exceptional service and trusted advice. We seek to be the choice for the military community and their families. Embrace a fulfilling career at USAA, where our core values - honesty, integrity, loyalty and service - define how we treat each other and our members. Be part of what truly makes us special and impactful. The Opportunity We are seeking a dedicated Development Product Owner Senior to support our Auto Modernization Development area. This role serves as a direct representative of the business on an agile team. Attains, understands, and communicates business vision and needs in order to write and refine user stories, prioritize work, and provide guidance to technical teams. Uses critical thinking, problem solving, and Agile principles to partner with business owners, subject matter experts, and the development team to build effective solutions. Possesses an advanced knowledge and understanding of and ability to work within multiple delivery methodologies, including Agile and other approaches, to deliver business value. We offer a flexible work environment that requires an individual to be in the office 4 days per week. This position can be based in one of the following locations: San Antonio, TX or Plano, TX. Relocation assistance is not available for this position. What you'll do: Works with business and Subject Matter Experts to understand business strategy and vision and then writes, refines, accepts and prioritizes stories and/or features to support effective and compliant solutions while balancing investment and business value. Owns and maintains a prioritized work backlog for one or more Agile teams. Product backlog includes complete user stories with acceptance criteria so that they are consumable and testable by the Agile team or program. Reviews and accepts output of I/T and/or business development to ensure specified acceptance criteria have been completed. Serves as direct representative of the business with one or more delivery teams, representing the customers' perspective throughout the product delivery cycle. Participates in a cross-functional team of user experience partners, designers, business analysts, developers, testers and others to develop, implement and release in alignment with program and/or product road maps. Partners with sponsors, stakeholders, and IT to facilitate, define and document relevant business processes, gaining an advanced understanding of the needs, measures, and risks & controls for the improvement area. Prepares the business for the change and provides tactics and metrics for benefits, adoption, and risk. Leverages existing change management routines, as needed. Works with different technologies, internal and external to have oversight of development, testing and controls. Applies advanced knowledge in the business development/execution area, regularly seeking out opportunities to enhance, improve and advance the function. Coaches and mentors other Product Owners. Demonstrates advanced knowledge in multiple business or system domains and capable of leading development across multiple teams at the project or program level. Ensures risks associated with business activities are effectively identified, measured, monitored, and controlled in accordance with risk and compliance policies and procedures. What you have: Bachelor's degree; OR 4 years of related experience (in addition to the minimum years of experience required) may be substituted in lieu of degree. 6 years of experience in process improvement, project delivery, business/requirements analysis or directly related to supported business operations/product line. Advanced knowledge of Microsoft Office products, applicable databases and product management tools. Advanced knowledge of multiple technical software delivery methodologies (i.e., Agile, Waterfall, SAFe). Advanced experience analyzing business requirements, process flows and use cases to find opportunities to streamline business processes in accordance with risk management framework and regulatory requirements. Advanced knowledge and demonstrated use of Process Engineering methodologies. Advanced ability to independently work to gather business requirements, process flows and use cases to develop and deliver on business capabilities within the approved methodology, writing user stories, and following the development process through user story acceptance. Experience in analyzing business requirements and ability to find opportunities to drive decisions and streamline business processes in accordance with risk management framework and regulatory requirements. What sets you apart: 8+ years P&C Personal Lines experience (ideally Auto) 6+ years of experience specializing in Personal Lines modernization using Guidewire Policy Center and/or Duckcreek. 6+ years of experience leading agile product development, transforming legacy systems, and enhancing customer experiences. Extensive experience with Guidewire or Duckcreek Out of the Box (OOTB) Insurance Product, including Quote, Policy Processing, Rating, and Underwriting. 6+ years business analyst/development product owner experience refining and prioritizing product backlog for teams. Experience directly leading modernization efforts for a large Tier 1 insurance carrier. Guidewire Associate/Analyst Certification US military experience through military service or a military spouse/domestic partner Compensation range: The salary range for this position is: $103,450 - $197,730. Compensation: USAA has an effective process for assessing market data and establishing ranges to ensure we remain competitive. You are paid within the salary range based on your experience and market data of the position. The actual salary for this role may vary by location. Employees may be eligible for pay incentives based on overall corporate and individual performance and at the discretion of the USAA Board of Directors. The above description reflects the details considered necessary to describe the principal functions of the job and should not be construed as a detailed description of all the work requirements that may be performed in the job. Benefits: At USAA our employees enjoy best-in-class benefits to support their physical, financial, and emotional wellness. These benefits include comprehensive medical, dental and vision plans, 401(k), pension, life insurance, parental benefits, adoption assistance, paid time off program with paid holidays plus 16 paid volunteer hours, and various wellness programs. Additionally, our career path planning and continuing education assists employees with their professional goals. For more details on our outstanding benefits, visit our benefits page on Applications for this position are accepted on an ongoing basis, this posting will remain open until the position is filled. Thus, interested candidates are encouraged to apply the same day they view this posting. USAA is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Description: About Us: Larimar Therapeutics Inc. is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp (CTI-1601), is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN), an essential protein to the mitochondria of patients with Friedreich's ataxia. Friedreich's ataxia is a rare, progressive, and fatal disease in which patients are unable to produce sufficient FXN due to a genetic abnormality. We have assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience. Our management team, employees, and consultants have significant expertise in discovery, non-clinical and clinical development, regulatory affairs, manufacturing and CMC. Our company's strategy is to become a leader in the treatment of rare diseases by leveraging our cell-penetrating technology platform and applying our team's know-how to the development of Nomlabofusp and our pipeline projects. We are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success. If you are searching for a company where urgency, agility, and commitment to science win the day - we welcome you! Position Summary: Larimar is seeking a CMC Regulatory Affairs Director to provide professional experience and leadership supporting the global CMC regulatory strategy and regulatory activities to bring products in development through global marketing authorization approval and launch. The Regulatory Affairs Director will be a key member of project teams and the role reports to the Regulatory Affairs Senior Director. Job Duties/Responsibilities: Larimar Team Membership The Director of CMC Regulatory Affairs will be a key member of the regulatory, clinical project, and technical operations (cross-functional) teams who will manage CMC regulatory aspects of projects related to global clinical trials, global health authority interactions and global marketing submissions and approvals. This person will work independently, and as a member of a team. Liaise internally with other members of the Regulatory Affairs department to coordinate the timely submission of CMC amendments, discuss suitable CMC strategies, evaluate global guidances, all to support the development programs of Larimar. Works closely with RA Sr. Director and serve as backup to other global regulatory activities Strategy, Guidance Responsible for defining, developing and executing global CMC regulatory strategies based on knowledge of guidelines with practical experience (previous IND, CTA, NDA, BLA filings) to successfully achieve objectives for complex Larimar projects Provides detailed and forward-looking tactical advice to technical teams and stakeholders to achieve timely and efficient program submissions and approval, while ensuring compliance with applicable global regulatory requirements Evaluates proposed manufacturing and quality changes for impact to current Health Authority Applications (INDs, CTAs) and provides strategic regulatory guidance for optimal implementation of changes. CMC Documentation, Submissions and HA interactions Develops and manages the content plans for global M3 CMC submissions or responses; coordinates document authoring (new or update), document review, and finalization of high-quality, style-guide compliant CMC documents that align with Larimar's regulatory submission timing and strategy With Larimar organization, manages the CMC portion of Larimar cross-functions team activity in preparation of meetings with global health authorities to define meeting objectives, development of meeting questions, execute the completion of the meeting package content and ultimate receipt of clear, specific and actional HA feedback based on the objectives of each meeting. Requirements: Key Experience, Skills and Knowledge: Minimum of 4-year undergraduate degree 10+ years' experience in a Regulatory Affairs role in the pharmaceutical industry, experience with Health Canada, EMA, MHRA and other local European agencies preferred Understanding of GxP systems and Quality principles Ability to research global regulatory guidance (nonclinical, clinical and CMC) and precedence to assist in the development and execution of global regulatory strategies. Knowledge of eCTD structure, components and basic regulatory operations which support in-house regulatory submissions Experience with preparation (authoring and review) of high-quality regulatory documents for global Health Authority submissions including but not limited to IND amendments, CTA submissions, Global Health Authority Meeting packages and Global marketing authorization applications. Excellent communication, time management and project management skills Continuous quality improvement mindset and attention to details Ability and willingness to work onsite, while maintaining strong collaboration in a hybrid work model. Can do attitude, flexibility, and mental agility Benefits: Larimar Therapeutics offers all employees a competitive salary with frequent market benchmarking, incentive stock options, a comprehensive benefits plan including 401K, and a flexible PTO policy. We are committed to equal-employment principles, and we recognize the value of committed employees who feel they are being treated in an equitable and professional manner. We strive to find ways to attract, develop and retain the talent needed to meet business objectives, and to recruit and employ highly qualified individuals representing the diverse communities in which we live. Employment policies and decisions on employment and promotion are based on merit, qualifications, performance, and business needs. The decisions and criteria governing the relationship with all candidates and employees are made in a non-discriminatory manner-without regard to age, race, color, national origin, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity or expression, religion, physical or mental disability, medical condition, legally protected genetic information, marital status, veteran status, military status, sexual orientation, or any other factor determined to be an unlawful basis for such decisions by federal, state, or local statutes. PIde713f1d658c-7779
12/05/2025
Full time
Description: About Us: Larimar Therapeutics Inc. is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp (CTI-1601), is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN), an essential protein to the mitochondria of patients with Friedreich's ataxia. Friedreich's ataxia is a rare, progressive, and fatal disease in which patients are unable to produce sufficient FXN due to a genetic abnormality. We have assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience. Our management team, employees, and consultants have significant expertise in discovery, non-clinical and clinical development, regulatory affairs, manufacturing and CMC. Our company's strategy is to become a leader in the treatment of rare diseases by leveraging our cell-penetrating technology platform and applying our team's know-how to the development of Nomlabofusp and our pipeline projects. We are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success. If you are searching for a company where urgency, agility, and commitment to science win the day - we welcome you! Position Summary: Larimar is seeking a CMC Regulatory Affairs Director to provide professional experience and leadership supporting the global CMC regulatory strategy and regulatory activities to bring products in development through global marketing authorization approval and launch. The Regulatory Affairs Director will be a key member of project teams and the role reports to the Regulatory Affairs Senior Director. Job Duties/Responsibilities: Larimar Team Membership The Director of CMC Regulatory Affairs will be a key member of the regulatory, clinical project, and technical operations (cross-functional) teams who will manage CMC regulatory aspects of projects related to global clinical trials, global health authority interactions and global marketing submissions and approvals. This person will work independently, and as a member of a team. Liaise internally with other members of the Regulatory Affairs department to coordinate the timely submission of CMC amendments, discuss suitable CMC strategies, evaluate global guidances, all to support the development programs of Larimar. Works closely with RA Sr. Director and serve as backup to other global regulatory activities Strategy, Guidance Responsible for defining, developing and executing global CMC regulatory strategies based on knowledge of guidelines with practical experience (previous IND, CTA, NDA, BLA filings) to successfully achieve objectives for complex Larimar projects Provides detailed and forward-looking tactical advice to technical teams and stakeholders to achieve timely and efficient program submissions and approval, while ensuring compliance with applicable global regulatory requirements Evaluates proposed manufacturing and quality changes for impact to current Health Authority Applications (INDs, CTAs) and provides strategic regulatory guidance for optimal implementation of changes. CMC Documentation, Submissions and HA interactions Develops and manages the content plans for global M3 CMC submissions or responses; coordinates document authoring (new or update), document review, and finalization of high-quality, style-guide compliant CMC documents that align with Larimar's regulatory submission timing and strategy With Larimar organization, manages the CMC portion of Larimar cross-functions team activity in preparation of meetings with global health authorities to define meeting objectives, development of meeting questions, execute the completion of the meeting package content and ultimate receipt of clear, specific and actional HA feedback based on the objectives of each meeting. Requirements: Key Experience, Skills and Knowledge: Minimum of 4-year undergraduate degree 10+ years' experience in a Regulatory Affairs role in the pharmaceutical industry, experience with Health Canada, EMA, MHRA and other local European agencies preferred Understanding of GxP systems and Quality principles Ability to research global regulatory guidance (nonclinical, clinical and CMC) and precedence to assist in the development and execution of global regulatory strategies. Knowledge of eCTD structure, components and basic regulatory operations which support in-house regulatory submissions Experience with preparation (authoring and review) of high-quality regulatory documents for global Health Authority submissions including but not limited to IND amendments, CTA submissions, Global Health Authority Meeting packages and Global marketing authorization applications. Excellent communication, time management and project management skills Continuous quality improvement mindset and attention to details Ability and willingness to work onsite, while maintaining strong collaboration in a hybrid work model. Can do attitude, flexibility, and mental agility Benefits: Larimar Therapeutics offers all employees a competitive salary with frequent market benchmarking, incentive stock options, a comprehensive benefits plan including 401K, and a flexible PTO policy. We are committed to equal-employment principles, and we recognize the value of committed employees who feel they are being treated in an equitable and professional manner. We strive to find ways to attract, develop and retain the talent needed to meet business objectives, and to recruit and employ highly qualified individuals representing the diverse communities in which we live. Employment policies and decisions on employment and promotion are based on merit, qualifications, performance, and business needs. The decisions and criteria governing the relationship with all candidates and employees are made in a non-discriminatory manner-without regard to age, race, color, national origin, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity or expression, religion, physical or mental disability, medical condition, legally protected genetic information, marital status, veteran status, military status, sexual orientation, or any other factor determined to be an unlawful basis for such decisions by federal, state, or local statutes. PIde713f1d658c-7779
Why USAA? At USAA, our mission is to empower our members to achieve financial security through highly competitive products, exceptional service and trusted advice. We seek to be the choice for the military community and their families. Embrace a fulfilling career at USAA, where our core values - honesty, integrity, loyalty and service - define how we treat each other and our members. Be part of what truly makes us special and impactful. The Opportunity We are seeking a dedicated Development Product Owner Senior to support our Auto Modernization Development area. This role serves as a direct representative of the business on an agile team. Attains, understands, and communicates business vision and needs in order to write and refine user stories, prioritize work, and provide guidance to technical teams. Uses critical thinking, problem solving, and Agile principles to partner with business owners, subject matter experts, and the development team to build effective solutions. Possesses an advanced knowledge and understanding of and ability to work within multiple delivery methodologies, including Agile and other approaches, to deliver business value. We offer a flexible work environment that requires an individual to be in the office 4 days per week. This position can be based in one of the following locations: San Antonio, TX or Plano, TX. Relocation assistance is not available for this position. What you'll do: Works with business and Subject Matter Experts to understand business strategy and vision and then writes, refines, accepts and prioritizes stories and/or features to support effective and compliant solutions while balancing investment and business value. Owns and maintains a prioritized work backlog for one or more Agile teams. Product backlog includes complete user stories with acceptance criteria so that they are consumable and testable by the Agile team or program. Reviews and accepts output of I/T and/or business development to ensure specified acceptance criteria have been completed. Serves as direct representative of the business with one or more delivery teams, representing the customers' perspective throughout the product delivery cycle. Participates in a cross-functional team of user experience partners, designers, business analysts, developers, testers and others to develop, implement and release in alignment with program and/or product road maps. Partners with sponsors, stakeholders, and IT to facilitate, define and document relevant business processes, gaining an advanced understanding of the needs, measures, and risks & controls for the improvement area. Prepares the business for the change and provides tactics and metrics for benefits, adoption, and risk. Leverages existing change management routines, as needed. Works with different technologies, internal and external to have oversight of development, testing and controls. Applies advanced knowledge in the business development/execution area, regularly seeking out opportunities to enhance, improve and advance the function. Coaches and mentors other Product Owners. Demonstrates advanced knowledge in multiple business or system domains and capable of leading development across multiple teams at the project or program level. Ensures risks associated with business activities are effectively identified, measured, monitored, and controlled in accordance with risk and compliance policies and procedures. What you have: Bachelor's degree; OR 4 years of related experience (in addition to the minimum years of experience required) may be substituted in lieu of degree. 6 years of experience in process improvement, project delivery, business/requirements analysis or directly related to supported business operations/product line. Advanced knowledge of Microsoft Office products, applicable databases and product management tools. Advanced knowledge of multiple technical software delivery methodologies (i.e., Agile, Waterfall, SAFe). Advanced experience analyzing business requirements, process flows and use cases to find opportunities to streamline business processes in accordance with risk management framework and regulatory requirements. Advanced knowledge and demonstrated use of Process Engineering methodologies. Advanced ability to independently work to gather business requirements, process flows and use cases to develop and deliver on business capabilities within the approved methodology, writing user stories, and following the development process through user story acceptance. Experience in analyzing business requirements and ability to find opportunities to drive decisions and streamline business processes in accordance with risk management framework and regulatory requirements. What sets you apart: 8+ years P&C Personal Lines experience (ideally Auto) 6+ years of experience specializing in Personal Lines modernization using Guidewire Policy Center and/or Duckcreek. 6+ years of experience leading agile product development, transforming legacy systems, and enhancing customer experiences. Extensive experience with Guidewire or Duckcreek Out of the Box (OOTB) Insurance Product, including Quote, Policy Processing, Rating, and Underwriting. 6+ years business analyst/development product owner experience refining and prioritizing product backlog for teams. Experience directly leading modernization efforts for a large Tier 1 insurance carrier. Guidewire Associate/Analyst Certification US military experience through military service or a military spouse/domestic partner Compensation range: The salary range for this position is: $103,450 - $197,730. Compensation: USAA has an effective process for assessing market data and establishing ranges to ensure we remain competitive. You are paid within the salary range based on your experience and market data of the position. The actual salary for this role may vary by location. Employees may be eligible for pay incentives based on overall corporate and individual performance and at the discretion of the USAA Board of Directors. The above description reflects the details considered necessary to describe the principal functions of the job and should not be construed as a detailed description of all the work requirements that may be performed in the job. Benefits: At USAA our employees enjoy best-in-class benefits to support their physical, financial, and emotional wellness. These benefits include comprehensive medical, dental and vision plans, 401(k), pension, life insurance, parental benefits, adoption assistance, paid time off program with paid holidays plus 16 paid volunteer hours, and various wellness programs. Additionally, our career path planning and continuing education assists employees with their professional goals. For more details on our outstanding benefits, visit our benefits page on Applications for this position are accepted on an ongoing basis, this posting will remain open until the position is filled. Thus, interested candidates are encouraged to apply the same day they view this posting. USAA is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
12/05/2025
Full time
Why USAA? At USAA, our mission is to empower our members to achieve financial security through highly competitive products, exceptional service and trusted advice. We seek to be the choice for the military community and their families. Embrace a fulfilling career at USAA, where our core values - honesty, integrity, loyalty and service - define how we treat each other and our members. Be part of what truly makes us special and impactful. The Opportunity We are seeking a dedicated Development Product Owner Senior to support our Auto Modernization Development area. This role serves as a direct representative of the business on an agile team. Attains, understands, and communicates business vision and needs in order to write and refine user stories, prioritize work, and provide guidance to technical teams. Uses critical thinking, problem solving, and Agile principles to partner with business owners, subject matter experts, and the development team to build effective solutions. Possesses an advanced knowledge and understanding of and ability to work within multiple delivery methodologies, including Agile and other approaches, to deliver business value. We offer a flexible work environment that requires an individual to be in the office 4 days per week. This position can be based in one of the following locations: San Antonio, TX or Plano, TX. Relocation assistance is not available for this position. What you'll do: Works with business and Subject Matter Experts to understand business strategy and vision and then writes, refines, accepts and prioritizes stories and/or features to support effective and compliant solutions while balancing investment and business value. Owns and maintains a prioritized work backlog for one or more Agile teams. Product backlog includes complete user stories with acceptance criteria so that they are consumable and testable by the Agile team or program. Reviews and accepts output of I/T and/or business development to ensure specified acceptance criteria have been completed. Serves as direct representative of the business with one or more delivery teams, representing the customers' perspective throughout the product delivery cycle. Participates in a cross-functional team of user experience partners, designers, business analysts, developers, testers and others to develop, implement and release in alignment with program and/or product road maps. Partners with sponsors, stakeholders, and IT to facilitate, define and document relevant business processes, gaining an advanced understanding of the needs, measures, and risks & controls for the improvement area. Prepares the business for the change and provides tactics and metrics for benefits, adoption, and risk. Leverages existing change management routines, as needed. Works with different technologies, internal and external to have oversight of development, testing and controls. Applies advanced knowledge in the business development/execution area, regularly seeking out opportunities to enhance, improve and advance the function. Coaches and mentors other Product Owners. Demonstrates advanced knowledge in multiple business or system domains and capable of leading development across multiple teams at the project or program level. Ensures risks associated with business activities are effectively identified, measured, monitored, and controlled in accordance with risk and compliance policies and procedures. What you have: Bachelor's degree; OR 4 years of related experience (in addition to the minimum years of experience required) may be substituted in lieu of degree. 6 years of experience in process improvement, project delivery, business/requirements analysis or directly related to supported business operations/product line. Advanced knowledge of Microsoft Office products, applicable databases and product management tools. Advanced knowledge of multiple technical software delivery methodologies (i.e., Agile, Waterfall, SAFe). Advanced experience analyzing business requirements, process flows and use cases to find opportunities to streamline business processes in accordance with risk management framework and regulatory requirements. Advanced knowledge and demonstrated use of Process Engineering methodologies. Advanced ability to independently work to gather business requirements, process flows and use cases to develop and deliver on business capabilities within the approved methodology, writing user stories, and following the development process through user story acceptance. Experience in analyzing business requirements and ability to find opportunities to drive decisions and streamline business processes in accordance with risk management framework and regulatory requirements. What sets you apart: 8+ years P&C Personal Lines experience (ideally Auto) 6+ years of experience specializing in Personal Lines modernization using Guidewire Policy Center and/or Duckcreek. 6+ years of experience leading agile product development, transforming legacy systems, and enhancing customer experiences. Extensive experience with Guidewire or Duckcreek Out of the Box (OOTB) Insurance Product, including Quote, Policy Processing, Rating, and Underwriting. 6+ years business analyst/development product owner experience refining and prioritizing product backlog for teams. Experience directly leading modernization efforts for a large Tier 1 insurance carrier. Guidewire Associate/Analyst Certification US military experience through military service or a military spouse/domestic partner Compensation range: The salary range for this position is: $103,450 - $197,730. Compensation: USAA has an effective process for assessing market data and establishing ranges to ensure we remain competitive. You are paid within the salary range based on your experience and market data of the position. The actual salary for this role may vary by location. Employees may be eligible for pay incentives based on overall corporate and individual performance and at the discretion of the USAA Board of Directors. The above description reflects the details considered necessary to describe the principal functions of the job and should not be construed as a detailed description of all the work requirements that may be performed in the job. Benefits: At USAA our employees enjoy best-in-class benefits to support their physical, financial, and emotional wellness. These benefits include comprehensive medical, dental and vision plans, 401(k), pension, life insurance, parental benefits, adoption assistance, paid time off program with paid holidays plus 16 paid volunteer hours, and various wellness programs. Additionally, our career path planning and continuing education assists employees with their professional goals. For more details on our outstanding benefits, visit our benefits page on Applications for this position are accepted on an ongoing basis, this posting will remain open until the position is filled. Thus, interested candidates are encouraged to apply the same day they view this posting. USAA is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
