Senior Manager, Biologics Analytical Research and Development

About Us

About the Role

As the Senior Manager, Biologics Analytical Research & Development, you will work collaboratively with the CMC organization to define strategies to solve complex analytical problems at the interface of biology, chemistry, and lab informatics disciplines. You will also support activities related to clinical drug substance and drug product stability studies at various contract laboratories.

You will be reporting to the Senior Director of Analytical Development and providing technology development, strategic leadership, and technical expertise in protein biologics method development, optimization, and qualification/validation. You will work with and build strong collaborations with external contract manufacturing and testing organizations (CDMOs and CTLs), As a key member of the project team, you will collaborate cross-functionally to ensure the timely and successful development of pipeline drug candidates. Responsibilities include working with and building strong collaborations with external CDMOs and CTLs, as well as with internal stakeholders, assisting the supervisor in monitoring contract laboratory stability testing, documentation, timely data review, and maintaining an up-to-date stability database.

This is an exciting opportunity to join a small, clinical-stage biotech company in a highly visible and dynamic role that will support drug development from mid-stage through commercialization. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.

Key Responsibilities

• BS. in analytical chemistry/biochemistry or related field with 5+ years of relevant experience, advanced degree highly preferred.
• Demonstrated experience in analysis of biologics, including Size Exclusion Chromatography (SEC), Ion Exchange Chromatography (IEX), Capillary Electrophoresis (CE-SDS, CEIEF) techniques, PCR, and cell-based potency assays and ELISA based assays.
• Prior experience with analytical method development for fusion proteins/ bi-specific antibodies is a plus.
• Experience with method validation, method transfer, analytical control strategy development, and execution in a GMP environment in support of biologics drug development programs.
• Strong working knowledge of analytical methodologies, Critical Quality Attributes/QbD/DOE principles, and data analysis and statistics for setting specifications.
• Ability to design and direct the development/qualification of release, characterization, and stability assays to support clinical drug substance / drug product testing and product/process development.
• Working knowledge of LIMS, Veeva, SAS and/or JMP is a plus
• Working knowledge of quality systems, GMP, FDA, ICH, and EMEA guidelines for stability, especially in biologics.
• A strong team player with excellent oral and written communication skills; ability to work both independently for development of assays and cross-functionally for successful transfer of assays. Plan assay optimization and documentation to meet program deadlines.
• Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment.

Experience

• Leading and executing strategies to develop, optimize, and qualify/validate analytical assays to support the release and stability testing of antibody-based therapeutic candidates.
• Help conceive, implement, manage, and analyze a diverse range of analytical/bioanalytical and biological testing for novel, complex biotherapeutic drug candidates in support of nonclinical and clinical development.
• Collaboratively evaluate, select, and manage CDMO and Contract Laboratories evaluation, including vendor audits, personnel training, and troubleshooting/investigations as needed for the transfer of analytical methods.
• Actively participate in change management, external investigation, and identify appropriate CAPA and implementation plan at third-party organizations.
• Manage the stability program, maintain an up-to-date stability database, and monitor/trend stability data at contract laboratories for drug substances/products within regulatory compliance.
• Support the Senior Director with proper documentation control related to stability activities, including SOPs, contracts, protocols, reports, change controls, and implementing stability data management systems.
• Monitor key process indicators (KPIs) metrics for stability programs and third-party oversight.
• Support drafting of regulatory filings in collaboration with Program Leadership and Regulatory. Authoring and reviewing internal technical reports, sections of regulatory filings (e.g., IND, BLA).
• Collaborate with other functional areas to ensure the timely and successful development of drug candidates.
• Ensure compliance with all relevant regulations, guidelines, and standards for analytical assays.