MSAT Drug Product Lead
About The Position
You will manage the Manufacturing Science and Technology (MSAT) Drug Product technical delivery for drug product manufacturing of a defined product or product family with a primary focus on New Product Introduction (NPI) and successful product launches, including delivering successful right-first-time product qualifications. You will work with cross-functional teams across functions to ensure robust product control strategies are implemented at manufacturing sites. 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 a relevant scientific, engineering or technical discipline.
- Minimum 8 years’ experience in pharmaceutical development, manufacturing or MSAT roles.
- Demonstrated experience in technology transfer, process validation and product lifecycle technical leadership.
- Practical knowledge of Good Manufacturing Practice (GMP) and regulatory expectations for drug product manufacture.
- Experience applying risk assessment approaches, process control strategies and quality tools to maintain product performance.
- Familiarity with regulatory dossiers and supporting health authority questions.
- Strong written and verbal communication skills and experience working with multi-disciplinary teams.
- Hands-on experience with oral solid dose drug product manufacturing.
Nice To Haves
- Advanced degree (MSc, PhD) in a relevant scientific or engineering discipline.
- Experience with Quality by Design, continued process verification and statistical process control.
- Track record of leading complex technical investigations and delivering sustainable corrective actions.
- Experience supporting regulatory filings, inspections and readiness activities.
- Ability to lead improvement projects that demonstrate measurable technical or operational value.
Responsibilities
- Act as the single technical point of contact for the drug product portfolio, owning technical risk, decision-making and product knowledge.
- Lead and deliver technology transfers to internal sites and external manufacturers, including transfer packages, training and readiness reviews.
- Manage continued process verification, process performance qualification and change management to maintain product robustness and compliance.
- Drive right-first-time execution of product qualification activities (e.g., PPQ/qualification readiness), managing appropriate governance through the relevant stage-gate forums as the program approaches PPQ, ensuring robust data, clear acceptance criteria and effective issue resolution.
- Define and maintain product control strategy and technical risk assessments.
- Translate that knowledge into clear documentation for operations.
- Support regulatory submissions and post approval inspections by providing technical input, comparability strategies and supporting documentation.
- Manage cross-functional investigations, root cause analysis and corrective actions for complex deviations and quality events.
Benefits
- health care and other insurance benefits (for employee and family)
- retirement benefits
- paid holidays
- vacation
- paid caregiver/parental and medical leave
- annual bonus
- eligibility to participate in our share based long term incentive program
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What This Job Offers
Job Type
Full-time
Career Level
Senior
