Product platform ASTL Lead

Responsibilities:
- Lead, develop, and coach a team of Analytical Science & technology leaders for analytical life cycle management.
- Own the E2E life-cycle analytical control strategy (quality attributes, specifications, comparability criteria).
- Lead cross-functional, cross-site teams covering analytical aspects for key GSK products/projects; provide analytical and stability expertise to technical teams and governance bodies.
- Coordinate complex analytical investigations; implement corrective and preventative actions.
- Review analytical/development/production data; support design of experiments; recommend improvements to control strategy.
- Mentor and provide scientific support for method development, scale-up, optimization, and operation for new process formulas/technologies/products.
- Own analytical aspects of regulatory submissions and RTQ process.
- Author/review/approve experimental protocols/reports for comparability studies.
- Support sites on analytical control strategy during regulatory inspections.

Required Qualifications / Skills:
- BSc in Biochemistry, Biology, Chemistry, Pharmacy, or related field.
- PhD (10+ years), MS (12+ years), or BS (15+ years) in (Bio)Pharma.
- Experience in analytical technologies; development/qualification/validation of analytical methods.
- Experience with New Product Introduction and manufacturing operations.
- Experience with IND/BLA work (biotherapeutics or vaccines) to GMP standards.
- Matrix leadership and project management.

Preferred Qualifications / Skills:
- Knowledge of MHRA/FDA and quality/safety requirements.
- Experience in technology transfer; Quality by Design, risk management; ICH Q7/Q8/Q9/Q10; GMP for 21st century.
- Root cause analysis leadership; people management; strong technical communication and stakeholder collaboration.