Manager, Analytical Development (Biologics)

As a Manager of Analytical Development, you will be joining a team of scientists responsible for managing analytical activities at CDMOs/CROs to ensure generation of high-quality and on-time data for development and registration of pre-clinical and clinical development-stage biologics within the Strategic External Development (SED) organization. The scope of the role spans release and stability indicating method development, qualification and validation, characterization, method trouble shooting, and method transfer. Under guidance, the incumbent will be responsible for executing aligned GSK and CDMO goals for analytical development of biologic therapeutic modalities, including antibodies, antibody-drug conjugates (ADCs), and bi- and multi-specifics. The role could further extend to investigations and preparation of CMC content for regulatory submissions.

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

• Execute analytical deliverables of product and process development of DS & DP, with a focus on product quality assessment, specification, release, stability and comparability studies.
• Manage analytical development activities performed at CDMOs/CROs associated with in-process (IPC, IPT, PAT) and in-use stability testing; release & stability method development, qualification/validation, trouble shooting and transfer; characterization of drug substance, drug product, and critical reagents.
• Collaborate with DS & DP 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, MAA, etc.).

• Assure all documentations and other regulatory compliance systems are maintained according to GSK corporate standards.
• 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/stakeholders 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:

• B.S., M.S. or Ph.D. in analytical chemistry, biochemistry, or related sciencee/enginerfield with biopharmaceutical industry experience.
• 5+ years of analytical development experience in (bio)pharmaceutical environment with biologics, with exposure to all stages of drug development.
• Experience with analytical method development, qualification, and validation.
• Experience with release and stability testing analytical strategies and methods, with a focus in purity analytical assays.
• Experience with biophysical-analytical characterization methods of DS and DP.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Understanding of a therapeutic modality’s structure-function relationship and how this impacts critical quality attributes and specifications.
• Hands-on experience with analytical methods for release, stability and characterization used for ADC and oligonucleotide therapeutic modalities.
• Hands-on experience in tech transfer and lifecycle management of methods.
• Proven ability to 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 drive for results and be innovative.

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

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more s