Senior SME - Drug Product (Small Molecule)

About this role

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.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: • 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.

Why You?

Basic Qualification We are seeking professionals with the following required skills and qualifications to help us achieve our goals • 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 Qualification If you have the following characteristics, it would be a plus • 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.

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.

What success looks like • 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.

We welcome applications from people with a wide range of backgrounds and experiences. If this role aligns with your skills and career goals, please apply. Tell us how your experience would help the team and what you hope to achieve at GSK. We look forward to hearing from you.

#LI-GSK

Skills CMC Strategy, Data-Driven Decision Making, Data Integrity, Debate Moderation, Digital Fluency, GxP Regulations, Lean Management, Problem Solving, Process Optimization, Project Leadership, Risk Awareness, Scientific Writing, Technology Transfer    

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

Why GSK? Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at -  usrecruitment.adjustments@gsk.com

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 his

Similar jobs

• Senior Director, Small Molecule Drug Product Manufacturing — BeiGene · Remote
• Senior Quality Manager – Drug Products — Becton Dickinson · USA UT - Sandy
• Sr. Scientist, Drug Product, MST — BeiGene · Remote
• MS&T Senior Manager – Drug Product — Vertex · Boston, MA
• Senior Scientist, Drug Product Development — Alumis · South San Francisco
• Head of CMC Regulatory Affairs – Small Molecules — Gilead Sciences · Foster City, California, United States
• Director, Small Molecule, Manufacturing Sciences and Technology — BeiGene · Remote
• Sr. Director, Pharmaceutical Product Strategy — McKesson · Irving, TX, USA - 6555 North State Highway 161 (P001) | Columbus, OH, USA - 910 John Street (CMM Main Campus) (C317) | Remote, United States