Product platform ASTL Lead
GSK
6 months ago
Remote friendly (Collegeville, PA)
United States
IT
Position Summary
Responsible for delivery of business-critical projects supporting late phase/lifecycle (PPQ/Commercial) analytical activities for key products. Defines strategy and leads implementation of E2E analytical control strategies, technology transfers, and technical/analytical support across the product lifecycle.
Responsibilities
- Lead/develop/coach a team of Analytical Science & Technology leaders for analytical life-cycle management.
- Own E2E life-cycle analytical control strategy; assess critical quality attributes, specifications, and comparability criteria.
- Lead cross-functional, cross-site teams; apply product-specific analytical and stability expertise to technical teams and governance bodies.
- Coordinate analytical investigations; implement appropriate CAPAs.
- Review existing process/analytical/development/production data; support DOE; recommend control strategy improvements.
- Provide scientific support/mentorship for method development, scale-up, optimization, and operation (production/purification/testing) for new technologies/products.
- Own analytical contributions to regulatory submissions and RTQ process.
- Author/review/approve protocols and reports for comparability studies; support sites during regulatory inspections.
Required Qualifications/Skills
- BSc (Biochemistry/Biology/Chemistry/Pharmacy or related)
- PhD 10+ years (or MS 12+, BS 15+) in (Bio)Pharma
- Experience in analytical technologies; analytical method development/qualification/validation
- New product introduction and manufacturing operations experience
- Regulatory agency experience (IND/BLA for (Bio)Therapeutics/vaccines) to GMP standards
- Matrix leadership and project management
Preferred Qualifications/Skills
- Knowledge of MHRA/FDA and quality/safety requirements
- Technology transfer experience
- Regulatory strategy/QbD and ICH Q7/Q8/Q9/Q10 + Product Lifecycle Management knowledge
- Root-cause analysis leadership; troubleshooting; people management
- Strong communication across sites, supply chain, R&D and CMO/CRO
Application Instructions
- For application accommodations: usrecruitment.adjustments@gsk.com
Responsible for delivery of business-critical projects supporting late phase/lifecycle (PPQ/Commercial) analytical activities for key products. Defines strategy and leads implementation of E2E analytical control strategies, technology transfers, and technical/analytical support across the product lifecycle.
Responsibilities
- Lead/develop/coach a team of Analytical Science & Technology leaders for analytical life-cycle management.
- Own E2E life-cycle analytical control strategy; assess critical quality attributes, specifications, and comparability criteria.
- Lead cross-functional, cross-site teams; apply product-specific analytical and stability expertise to technical teams and governance bodies.
- Coordinate analytical investigations; implement appropriate CAPAs.
- Review existing process/analytical/development/production data; support DOE; recommend control strategy improvements.
- Provide scientific support/mentorship for method development, scale-up, optimization, and operation (production/purification/testing) for new technologies/products.
- Own analytical contributions to regulatory submissions and RTQ process.
- Author/review/approve protocols and reports for comparability studies; support sites during regulatory inspections.
Required Qualifications/Skills
- BSc (Biochemistry/Biology/Chemistry/Pharmacy or related)
- PhD 10+ years (or MS 12+, BS 15+) in (Bio)Pharma
- Experience in analytical technologies; analytical method development/qualification/validation
- New product introduction and manufacturing operations experience
- Regulatory agency experience (IND/BLA for (Bio)Therapeutics/vaccines) to GMP standards
- Matrix leadership and project management
Preferred Qualifications/Skills
- Knowledge of MHRA/FDA and quality/safety requirements
- Technology transfer experience
- Regulatory strategy/QbD and ICH Q7/Q8/Q9/Q10 + Product Lifecycle Management knowledge
- Root-cause analysis leadership; troubleshooting; people management
- Strong communication across sites, supply chain, R&D and CMO/CRO
Application Instructions
- For application accommodations: usrecruitment.adjustments@gsk.com