Small Molecule Drug Substance Lead
GSK
August 29, 2026
Remote friendly (Durham, NC)
United States
Clinical Research and Development
Responsibilities:
- Lead the drug substance workstream for small molecule programs, guiding process development, scale-up, and technology transfer.
- Build and maintain integrated development plans, milestones, and decision points aligned to program timelines and regulatory expectations.
- Design and execute experiments for process characterization, robustness studies, and scale-up risk mitigation.
- Coordinate cross-functional teams and external partners to resolve technical issues and secure clinical and commercial supply readiness.
- Prepare technical summaries, risk assessments, and recommendations for project leadership and governance.
- Mentor colleagues, share practical knowledge, and promote inclusive ways of working.
Key working relationships:
- Collaborate with CMC, analytical development, quality, regulatory affairs, clinical supply, manufacturing, and external contract organizations.
- Engage suppliers, contract manufacturers, and external labs to align technical approaches and timelines.
- Present program status, risks, and mitigation plans to project teams and decision forums.
Qualifications:
Required:
- Bachelor’s degree in chemistry, chemical engineering, pharmaceutical sciences, or related field.
- Minimum 10 years industry experience in small molecule drug substance process development, scale-up, or CMC roles.
- Practical experience in technology transfer to manufacturing sites or CMOs.
- Knowledge of process design, process characterization concepts, and control strategy development.
- Proven ability to lead cross-functional workstreams in a matrixed environment.
Preferred:
- Clear written and verbal communication skills for diverse technical and business audiences.
- MS or PhD in chemistry, chemical engineering, or pharmaceutical sciences.
- Experience in late-stage development, regulatory submissions, or supporting regulatory interactions.
- Experience with high-potency compounds/special handling or complex purification processes.
- Formal project management training or experience managing multi-site transfers.
- Track record of mentoring or leading small technical teams.
- Familiarity with quality systems, risk management, and data integrity principles.
Working model:
- Hybrid in the United States; regular on-site work for lab/manufacturing/key activities with focused remote time.
Application instructions:
- If this role matches your skills and career goals, apply.
- Lead the drug substance workstream for small molecule programs, guiding process development, scale-up, and technology transfer.
- Build and maintain integrated development plans, milestones, and decision points aligned to program timelines and regulatory expectations.
- Design and execute experiments for process characterization, robustness studies, and scale-up risk mitigation.
- Coordinate cross-functional teams and external partners to resolve technical issues and secure clinical and commercial supply readiness.
- Prepare technical summaries, risk assessments, and recommendations for project leadership and governance.
- Mentor colleagues, share practical knowledge, and promote inclusive ways of working.
Key working relationships:
- Collaborate with CMC, analytical development, quality, regulatory affairs, clinical supply, manufacturing, and external contract organizations.
- Engage suppliers, contract manufacturers, and external labs to align technical approaches and timelines.
- Present program status, risks, and mitigation plans to project teams and decision forums.
Qualifications:
Required:
- Bachelor’s degree in chemistry, chemical engineering, pharmaceutical sciences, or related field.
- Minimum 10 years industry experience in small molecule drug substance process development, scale-up, or CMC roles.
- Practical experience in technology transfer to manufacturing sites or CMOs.
- Knowledge of process design, process characterization concepts, and control strategy development.
- Proven ability to lead cross-functional workstreams in a matrixed environment.
Preferred:
- Clear written and verbal communication skills for diverse technical and business audiences.
- MS or PhD in chemistry, chemical engineering, or pharmaceutical sciences.
- Experience in late-stage development, regulatory submissions, or supporting regulatory interactions.
- Experience with high-potency compounds/special handling or complex purification processes.
- Formal project management training or experience managing multi-site transfers.
- Track record of mentoring or leading small technical teams.
- Familiarity with quality systems, risk management, and data integrity principles.
Working model:
- Hybrid in the United States; regular on-site work for lab/manufacturing/key activities with focused remote time.
Application instructions:
- If this role matches your skills and career goals, apply.