The Associate Director/Senior Manager of Analytical Development will lead a matrix team of analytical scientists and be responsible for development, manufacturing, release and stability testing, and characterization of starting materials, API/drug substance and drug products of small molecule and/or oligonucleotide therapeutic modalities within the Strategic External Development (SED) organization.

As a matrix team leader, you will function as an analytical project lead and technical lead in a broad analytical development role that spans from management of collaborations with appointed CDMOs & CROs to overseeing the development, execution and strategic alignment of the goals of GSK and CDMO for successful development and regulatory submissions of small molecule and/or oligonucleotide therapeutics. 

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

• Provide analytical project leadership, guidance, and strategic direction and planning to small molecule and/or oligonucleotide projects in different phases of CMC development.
• Provide scientific leadership to the Analytical Development group in developing technical capability and analytical strategies, with an accountability for oversight of analytical activities performed at external partners.
• Build and maintain strong relationships with internal and external partners to ensure successful analytical strategies are positioned and implemented for the pipeline projects.
• Develop and execute strategies for process and product characterization with a focus on regulatory starting materials (RSMs), product quality and quality attribute assessments, specification, release, stability and comparability studies by strong cross-function collaborations with process development and quality.
• Author, review and/or approve key source documents for relevant sections of regulatory filings, including IND, IMPD, NDA, or MAA.
• Lead and track analytical delivery commitments of project and analytical team to support all CMC filing activities of pre-INDs, INDs, IMPDs, CTAs or NDAs, draft and review of regulatory filings and address RTQs.

• Partner with Quality Assurance and Regulatory Affairs-CMC to assure all documentation and regulatory compliance systems are maintained according to GSK corporate standards.
• Establish and implement processes, technical concept and methodologies to enable effective collaboration with CRO/CDMO business partners to ensure efficiency and high quality of results.
• Provide clear communication to project team and partners as well as functional line and matrix 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:​

• Senior Manager: PhD or M.S. in chemistry, biochemistry, chemical engineering, or related science/engineering with 8+ years of combined pharmaceutical industry and postgraduate experience.
• Associate Director: PhD or M.S. in analytical chemistry, chemistry, chemical engineering, or related science/engineering with 10+ years of combined pharmaceutical industry and postgraduate experience.
• 5+ years of CMC analytical development and/or chemical development experience for small molecules and/or oligonucleotides.
• 5+ years of hands-on experience in analytical method development, qualification and validation for release and stability of small molecule and/or oligonucleotide therapeutics.
• 3+ year of experience in CMC late-stage product and process development and/or market application of small molecule and/or oligonucleotide therapeutics.
• 3+ years of experience in CMC analytical project leadership experience in late-stage development.
• 2+ years of experience in tech transfer of methods and life cycle management.

Preferred Qualifications:

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

• Exposure to all stages of drug development.
• Proven ability to manage projects and work with cross-functional teams comprised of internal and/or external contacts.
• Experience in analytical characterization of small molecule and/or oligonucleotide therapeutics for structure elucidation and impurity characterization.
• Experience with mRNA, synthetic peptides and conjugated therapies.
• 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 and drive for results.

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