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

The Associate Director will be responsible for project and matrix team management, 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 GSK and CDMO goals for successful development and regulatory submissions of 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 leadership, guidance, and strategic direction and planning to analytical projects of oligonucleotides in different phases of CMC development.
• Provide scientific leadership to the Analytical Development group in development of scientific capability and analytical strategies, with accountability for oversight of analytical activities performed at external partners for oligonucleotide therapeutic modality.
• 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 for process characterization with a focus on regulatory starting materials (RSMs) and 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.
• Lead and track analytical development commitments of project and team deliveries to support all CMC filing activities such as pre-INDs, INDs, IMPDs, CTAs or NDAs, draft and review of regulatory filings, and address RTQs.
• Author, review and/or approve key source documents for relevant sections of regulatory filings, examples include IND, IMPD, NDA, or MAA.

• Assure all documentation 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.
• 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:

• Ph.D. in chemistry, biochemistry, chemical engineering, or related science/engineering with 8 + years’ experience
• Or M.S. in chemistry, biochemistry, chemical engineering, or related science/engineering with 10 + years’ experience
• 8+ years of CMC analytical development and/or chemical development experience for oligonucleotides and/or small molecules.
• 5+ of hands-on experience in analytical assay development, qualification and validation for release and stability of oligonucleotide and/or small molecule therapeutics.
• 5+ of hands-on experience in analytical characterization assay development of oligonucleotide and/or small molecule therapeutics for structure elucidation and impurity characterization.
• 3+ years of experience in late-stage product and process development and/or market application of oligonucleotide and/or small molecule therapeutics.
• 3+ years of analytical project leadership experience in late-stage development of oligonucleotide and/or small molecule therapeutics.
• 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 with matrix team management.
• 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.

#LI-GSK

#CMCDevelopmentGSK

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 sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

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