Sr Director - Molecule Steward Lead
The Sr Director - Molecule Steward Lead will lead a group (5-15) of Molecule Stewards who have end to end technical accountability for a portfolio of innovative programs, including Drug Substance, Drug Product, inspection, assembly, packing and related support activities. The role provides strategic technical leadership to ensure successful new product introduction, launch, and continuous improvement across the lifecycle.
Position Summary
The Senior Director will drive program alignment across a portfolio of assets from Commit to Commercial Design through product sunset. Responsibilities include representing MSAT at key product lifecycle milestones such as Product Control Strategy development, Technology Transfer, PPQ, and ongoing maintenance of the Control Strategy to meet quality and business objectives. The Sr Director is the recognized expert in long acting injectable products and will deliver the technical elements of the GSC strategy for these products.
Key Responsibilities
* Manage a group of Molecule Stewards (5 10) accountable for end to end technical leadership of pipeline and in line programs, recruiting and developing a world class team.
* Serve on the Molecule Steward leadership team to drive portfolio excellence.
* Define and own the technical strategy through the product lifecycle, including technology transfers, process qualification, and risk management.
* Develop and deliver the Technical Lifecycle Plan (TLCP), supporting geographical expansion and new technologies.
* Maintain product history and knowledge alignment with global standards, serving as key input for process history files.
* Provide technical leadership on multi site investigations, deviations, troubleshooting, and major change programmes.
* Stay current on scientific developments, regulatory policies, and industry best practices.
* Coordinate technical review of regulatory submissions and responses across MSAT and other stakeholders.
* Act as MSAT single point accountable decision maker for GSC strategic and CMC teams, ensuring robust product control strategy.
* Collaborate with technical staff across supply chain sites, MSAT, and R&D, mentoring and developing technical talent.
* Manage stakeholders effectively and apply risk based approaches.
Basic Qualifications
* Bachelor's degree in life sciences, pharmaceutical sciences, biochemical engineering, or a related field.
* Experience in biopharmaceutical development or a related scientific area.
* Experience supporting molecule program management across preclinical and/or clinical stages.
* Experience working within cross functional, matrixed development teams.
* Experience working within external regulatory frameworks (e.g., FDA, EMA, MHRA, PMDA).
* Experience supporting technology transfer activities within a product development environment.
Preferred Qualifications
* PhD or Master's degree.
* Strong communication skills in English and experience presenting technical information to diverse audiences.
* Experience using risk based approaches and project management tools.
* Knowledge of global regulatory pathways for clinical development.
* Comfort working in matrixed and cross cultural teams.
GSK is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex or any other protected characteristic.