Associate Director (Team Lead), Analytical Development, SED-4

The Associate Director of Analytical Development will lead a team of analytical scientists responsible for development, manufacturing, release and stability testing, and characterization of drug substances/API and drug products of Small Molecule and Oligonucleotide therapeutic modalities within the Strategic External Development (SED) organization.

The Associate Director will be responsible for people and project management, who would also function as an analytical project lead and technical lead in a broad analytical development role that spans from managing collaboration with appointed CDMOs to overseeing, developing, and executing aligned GSK and CDMO goals for development of small molecules and oligonucleotides.  It will further extend to investigation, preparation and reviewing of CMC content for regulatory submissions, as well as response to regulatory agencies.

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

• Provide leadership, guidance, and strategic direction to a group of analytical scientists and ensure staff are developed to their fullest potentials by providing coaching, mentoring, and appropriate learning opportunities.
• Provide leadership to the team in development of scientific capability and analytical strategies, with accountability for oversight of analytical activities performed at external partners.
• Provide clear communication to team and partners as well as functional line and matrix management regarding progress against technical / project as well as organizational objectives/milestones.
• Build and maintain strong relationships with internal and external partners to ensure successful analytical strategies are positioned and implemented for the pipelines within the organization.
• Develop and execute strategies and process characterization with a focus on product quality assessment, specification, release, stability and comparability studies.
• Collaborate with process, formulation 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 examples could be IND, IMPD, NDA, or MAA.
• Lead and track analytical development commitments of project and team’s deliveries to support all CMC filing activities such as pre-INDs, INDs, IMPDs, CTAs or NDAs, and review of regulatory filings, and address RTQs.

• Assure all documentations and other 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.
• Partner with Quality Assurance and Regulatory Affairs-CMC to ensure completion of appropriate documentation and maintenance of high-quality standards.

Why you?

Basic Qualifications:

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

For the Small Molecule and Oligonucleotide modality roles:

• M.S. or Ph.D. degree in analytical chemistry, chemistry, or chemical engineering with pharmaceutical industry experience
• 10 or more years analytical development experience
• 3 or more years of experience in late-stage product and process development and market application of small molecule or oligonucleotide therapeutics.
• 3 or more years of people management and analytical project leadership experience.
• 5 or years of experience in analytical assay development, qualification and validation.
• 2 or more years of experience in methods tech transfer of 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 with mRNA, peptides and conjugated biologic therapeutics modalities.
• 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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