Associate Director/Senior Manager- Small Molecule / Oligonucleotide Modalities, Analytical Development SED

Location

Waltham, MA | United States

Job description

Site Name: USA - Massachusetts - Waltham, Stevenage, Upper Providence
Posted Date: Feb 20 2024

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.

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

Why Us?

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 organization 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.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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