Senior SME - Drug Product (Small Molecule)

Position Summary

You will be the senior subject matter expert for drug product small molecule supply with external manufacturing partners.

You will lead technical transfers, ensure product and process robustness, and support regulatory readiness across the product lifecycle.

You will work closely with cross-functional teams including MSAT, Quality, R&D, Procurement and external CMOs.

We value clear problem solving, practical scientific judgement, and collaborative leadership.

This role offers growth, meaningful impact and the chance to help GSK unite science, technology and talent to get ahead of disease together.

Key Responsibilities

• Act as the single technical point of contact for small molecule drug product activities with external manufacturers.
• Lead and deliver technology transfers to contract manufacturing organizations, including transfer packages, training and readiness reviews.
• Define and maintain product control strategies, technical risk assessments, and acceptance criteria to support right-first-time product qualifications.
• Manage process validation, continued process verification and change management to maintain product robustness and compliance.
• Lead cross-functional investigations, root cause analysis, and corrective actions for complex deviations and quality events.
• Provide technical input for regulatory filings, inspection readiness, and post-approval activities as required.
• Basic Qualifications
• Bachelor's degree in Chemistry, Chemical Engineering, Pharmacy, Pharmaceutical Science, or related technical field.
• Minimum 8 years' experience in pharmaceutical drug product development, manufacturing, MSAT, or technical support roles.
• Demonstrated experience with technology transfer to external CMOs and supplier management.
• Practical knowledge of Good Manufacturing Practice (GMP) and regulatory expectations for drug product manufacture.
• Experience in process validation, continued process verification, and application of risk assessment tools.
• Preferred Qualifications
• Strong written and verbal communication skills and proven ability to work effectively with multi-disciplinary teams.
• Flexibility to support and collaborate with international teams across varying time zones.
• Advanced degree (MSc, Ph D) in a relevant scientific or engineering discipline.
• Hands‑on experience with oral solid dose drug product manufacturing, scale‑up, or qualification activities.
• Experience with Quality by Design, statistical process control, and lifecycle management tools.
• Track record of leading complex technical investigations and implementing sustainable corrective actions.
• Experience supporting regulatory filings and inspections with external manufacturing partners.
• Proven ability to lead improvement projects that deliver measurable technical or operational value.
• Work Arrangement
• This role is hybrid. You will be expected to visit external manufacturing sites and internal manufacturing sites as required.
• Fully remote or permanent home‑working arrangements are not available.
• Success Criteria
• Smooth, timely technology transfers to external partners with clear acceptance criteria met.
• Robust product control strategies that maintain product quality through scale‑up and commercial supply.
• Timely resolution of technical issues with clear root cause analysis and sustainable preventive actions.
• Strong collaborative relationships with internal teams and external manufacturers built on trust and clarity.

Skills

• CMC Strategy
• Data‑Driven Decision Making
• Data Integrity
• Debate Moderation
• Digital Fluency
• Gx P Regulations
• Lean Management
• Problem Solving
• Process Optimization
• Project Leadership
• Risk Awareness
• Scientific Writing
• Technology Transfer

Benefits

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

Equal Opportunity Statement

GSK is an Equal Opportunity Employer.

This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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