JD – Senior Manager, Analytical Development, SED

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 Strategic External Development (SED) 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 to directly support GSK’s biologics pipeline.

The scope of the role spans from overseeing release- and stability-indicating method development and validation to characterization and comparability studies, as well as reference standard qualification. Under minimal guidance, the successful candidate will be responsible for overseeing, developing, and executing aligned CDMO and GSK goals for large molecule analytical development. It will further extend to investigations and preparation of CMC content for regulatory submissions, method transfer and troubleshooting.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

• Lead and manage analytical development activities performed at 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.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Ph.D. or M.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.) of combined biopharmaceutical industry and postgraduate analytical 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 of therapeutic proteins/antibody-drug conjugates (ADCs), and preferably with analytical project leadership experience of biologics.
• 1+ years of experience in tech transfer of methods and life cycle management.

Preferred Qualifications:

• Experience with a variety of biologic modalities (ADCs, monoclonal antibodies, bi- and multi-specifics, co-formulated drug products, etc.), and exposure to all stages of biologics drug development.
• Hands-on experience in biochemical and/or biophysical assay development and 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.

Please visit  GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why Us?

GSK is a global biopharma c