Scientific Leader
GSK
4 hours ago
On-site
Collegeville, PA
Clinical Research and Development
Position Summary
As a Scientific Leader in the Analytical Projects-US department (Analytical Development), you will lead the development, validation, and implementation of analytical methods and state-of-the-art analytical technologies. You will support small molecule, mAb and/or Antibody Drug Conjugate (ADC) process development and manufacturing and engage with CMC project teams and other stakeholders across pharmaceutical development.
Key Responsibilities
- Key member/leader of matrix analytical teams in early or late small molecule, mAb and/or ADC development; advance analytical methods, control strategies, and GMP release and stability deliverables to support pipeline progression.
- Departmental expert in key analytical techniques; lead troubleshooting, enable innovation, and integrate new technologies.
- Support GMP compliance activities (instrument qualification, deviation management, change control).
- Drive standardization and best practices across analytical platforms to improve harmonization, efficiency, and quality.
- Act as subject matter expert during regulatory inspections, GMP audits, and agency interactions.
- Author and review high-quality documentation (scientific papers, patents, regulatory submissions, CQAs, specifications).
- Author regulatory submissions (IND/IMPD through NDA/MAA).
- Perform complex data analysis and interpretation for drug substance and drug product development decisions.
- Collaborate cross-functionally with R&D, Global Supply Chain (GSC), and external partners to resolve analytical challenges.
- Mentor less experienced staff.
- Oversee method/process development including qualification, validation, technical transfer, and continuous improvement with strong documentation and knowledge sharing.
Basic Qualifications
- Bachelor’s degree in a scientific/technical field (e.g., biology, chemistry, biochemistry, engineering).
- 10+ years of experience (or 7+ years with a PhD) in biopharmaceutical/biotechnology development or manufacturing.
- Experience working with cross-functional global/geographically diverse teams; matrix and project management experience.
- Experience with analytical separations methods (HPLC, uHPLC, GC) and detection modes (UV, FLD, CAD, MS, ELSD).
- Experience developing and validating analytical methods per pharmacopeial requirements and lifecycle management standards.
- Experience in analytical or process method development and validation.
- Experience applying GMP and relevant regulatory standards for pharmaceutical product development (including scale up and technology transfer).
- Experience creating/delivering written and verbal technical documentation; strong communication; document experimental plans and results.
Preferred Qualifications
- MS or PhD in a relevant scientific discipline.
- Experience leading ADC analytical activities.
- Experience with external partners (CROs/CDMOs).
- Proven technology transfer experience (internal sites and/or external partners).
- Contributions to regulatory submissions; preparation of technical reports.
- Track record implementing process improvements or digital solutions improving quality/efficiency/operational performance.
Work Arrangements
- On-site role (3+ days/week); remote/fully home-working not available.
How to Apply
- Submit your resume and a short cover letter describing how your experience matches the basic qualifications and what excites you about the role.
As a Scientific Leader in the Analytical Projects-US department (Analytical Development), you will lead the development, validation, and implementation of analytical methods and state-of-the-art analytical technologies. You will support small molecule, mAb and/or Antibody Drug Conjugate (ADC) process development and manufacturing and engage with CMC project teams and other stakeholders across pharmaceutical development.
Key Responsibilities
- Key member/leader of matrix analytical teams in early or late small molecule, mAb and/or ADC development; advance analytical methods, control strategies, and GMP release and stability deliverables to support pipeline progression.
- Departmental expert in key analytical techniques; lead troubleshooting, enable innovation, and integrate new technologies.
- Support GMP compliance activities (instrument qualification, deviation management, change control).
- Drive standardization and best practices across analytical platforms to improve harmonization, efficiency, and quality.
- Act as subject matter expert during regulatory inspections, GMP audits, and agency interactions.
- Author and review high-quality documentation (scientific papers, patents, regulatory submissions, CQAs, specifications).
- Author regulatory submissions (IND/IMPD through NDA/MAA).
- Perform complex data analysis and interpretation for drug substance and drug product development decisions.
- Collaborate cross-functionally with R&D, Global Supply Chain (GSC), and external partners to resolve analytical challenges.
- Mentor less experienced staff.
- Oversee method/process development including qualification, validation, technical transfer, and continuous improvement with strong documentation and knowledge sharing.
Basic Qualifications
- Bachelor’s degree in a scientific/technical field (e.g., biology, chemistry, biochemistry, engineering).
- 10+ years of experience (or 7+ years with a PhD) in biopharmaceutical/biotechnology development or manufacturing.
- Experience working with cross-functional global/geographically diverse teams; matrix and project management experience.
- Experience with analytical separations methods (HPLC, uHPLC, GC) and detection modes (UV, FLD, CAD, MS, ELSD).
- Experience developing and validating analytical methods per pharmacopeial requirements and lifecycle management standards.
- Experience in analytical or process method development and validation.
- Experience applying GMP and relevant regulatory standards for pharmaceutical product development (including scale up and technology transfer).
- Experience creating/delivering written and verbal technical documentation; strong communication; document experimental plans and results.
Preferred Qualifications
- MS or PhD in a relevant scientific discipline.
- Experience leading ADC analytical activities.
- Experience with external partners (CROs/CDMOs).
- Proven technology transfer experience (internal sites and/or external partners).
- Contributions to regulatory submissions; preparation of technical reports.
- Track record implementing process improvements or digital solutions improving quality/efficiency/operational performance.
Work Arrangements
- On-site role (3+ days/week); remote/fully home-working not available.
How to Apply
- Submit your resume and a short cover letter describing how your experience matches the basic qualifications and what excites you about the role.