Senior SME - Drug Product (Small Molecule)

GSK•Durham, NC

7d•Hybrid

About The Position

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. This role will provide YOU the opportunity to lead key activities to progress YOUR career.

Requirements

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.

Nice To Haves

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, PhD) 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.

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.