Product platform ASTL Lead

Responsibilities:
- Lead, develop, and coach a team of Analytical Science & technology leaders for analytical life cycle management.
- Own the E2E analytical control strategy: critical quality attribute assessment, specifications, and comparability criteria.
- Lead cross-functional, cross-site teams to cover analytical aspects and provide product-specific analytical/stability expertise to technical teams and governance bodies.
- Coordinate complex analytical investigations; implement corrective and preventive actions.
- Review process/analytical development/production data; support experimental design; recommend control strategy changes/improvements.
- Mentor/support development, scale-up, optimization, and operation of methods for production, purification, and testing of new process formulas/technologies/products.
- Own analytical input for regulatory submissions and RTQ; author/review/approve comparability study protocols/reports.
- Support sites during regulatory inspections on analytical control strategy matters.

Required Qualifications/Skills:
- BSc in Biochemistry, Biology, Chemistry, Pharmacy, or related field.
- PhD (10+ years) / MS (12+ years) / BS (15+ years) in (Bio)Pharma.
- Experience in analytical technologies; method development/qualification/validation.
- New product introduction and manufacturing operations experience.
- Regulatory agency experience (IND/BLA for (Bio)therapeutics or vaccines) and GMP standards.
- Matrix leadership and project management.

Preferred Qualifications/Skills:
- Knowledge of MHRA/FDA and quality/safety requirements.
- Technology transfer experience.
- Knowledge of Quality by Design, GMP/ICH (Q7–Q10), and product lifecycle management.
- Root-cause analysis leadership; troubleshooting and analytical methods validation track record.
- People management; strong technical communication and stakeholder/cross-functional collaboration skills.