Senior Manager or Associate Director, Analytical Development

GSK • Upper Providence, PA

6d

About The Position

As a Senior Manager of Analytical Development, you will join a team of scientists responsible for managing analytical activities throughout development and registration of pre-clinical and development-stage biologic candidates within the DDS Analytical Projects organization. The successful candidate will serve as a project and/or technical lead in a broad analytical area and manage the collaboration with appointed CDMOs & CROs to support GSK’s biologics pipeline. The scope of the role spans from leading release- and stability-indicating method development and validation to characterization and comparability studies, as well as reference standard qualification. It will further extend to method transfer and troubleshooting, investigations and preparation of CMC content for regulatory submissions. Under minimal guidance, the successful candidate will be responsible for overseeing, developing, and executing aligned GSK goals for biologics analytical development with GSK internal labs and CDMO/CRO.

Requirements

• Ph.D., M.S. or B.S. in chemistry, biochemistry, cell biology, biochemical/bioprocess engineering, or related science/engineering field with extensive biopharmaceutical industry experience.
• 6+ years (for Ph.D.) or 8+ years (for M.S.) or 10+ years (for B.S.) of biopharmaceutical industry experience.
• 5+ years of hands-on experience with biochemical, biophysical and/or biological methods used for biopharmaceutical characterization.
• 3+ years of CMC analytical development experience, preferably with analytical project leadership experience of biologics.
• Experience in technical transfer of methods and life cycle management.

Nice To Haves

• Experience with a variety of biologic modalities (ADCs, monoclonal antibodies, bi- and multi-specifics, fusion proteins, co-formulated drug products, etc.), and exposure to all stages of biologics drug development.
• Hands-on experience in biochemical and/or biophysical assay development, qualification/validation.
• Thorough knowledge of structure-function relationship of therapeutic proteins.
• Proven ability to manage projects and work with cross-functional teams comprised of internal and/or external contacts.
• Ability to work in a fast-paced, multi-disciplinary and dynamic environment with potential for changing priorities, with flexibility to support multiple development programs simultaneously.
• Ability to lead innovation, change, and drive for results.

Responsibilities

• Lead and manage analytical development activities performed at GSK and CROs/CDMOs associated with method development, qualification/validation, transfer and characterization of drug substance, drug product, in-process testing and reference standards qualification.
• Develop and execute strategies for product and process characterization with a focus on CQA assessment, specification, release, stability, and comparability studies.
• Facilitate tech transfer of methods to GMP testing facility, commercial groups and to CMO's.
• Collaborate with process and quality functions to ensure strong cross functional collaborations and integrated process and product development and characterization.
• Author, review and/or approve key source documents for relevant sections of regulatory filings (IND, IMPD, BLA, etc.).
• Lead and track analytical development commitments to support all CMC filing activities for pre-INDs, INDs, IMPDs, CTAs and BLAs, draft and review of regulatory filings, and address RTQs.
• Assure all documentation and other regulatory compliance systems are maintained according to GSK corporate standards.
• Establish and implement processes, technical concepts, and methodologies to enable effective collaboration with CRO/CDMO business partners to ensure efficiency and high quality of results.
• Partner with Quality Assurance and Regulatory Affairs-CMC to ensure completion of appropriate documentation and maintenance of high-quality standards.
• Provide clear communication to partners and functional line management regarding progress against technical and project objectives/milestones.

Benefits

• GSK US Benefits Summary

What This Job Offers

• Job Type: Full-time
• Career Level: Senior