Director, Drug Product Development
Structure Therapeutics
15 days ago
Remote friendly (South San Francisco, CA)
United States
Operations
Position Summary
Reporting to the Head of Drug Product Technical Operations, lead late-stage small molecule drug product programs, including robust and scalable drug product formulations and manufacturing processes. Focus areas include Late Stage program, PPQ, commercialization readiness, and life-cycle management.
Job Responsibilities
- Lead late-stage drug product formulation and process development, including FMEA risk assessments, QbD, PPQ planning/execution, commercialization readiness, and life-cycle management.
- Partner with CROs and CDMOs to develop scalable, commercially viable processes; troubleshoot variability and optimize performance and yields.
- Transition early-stage assets into late-stage development and commercial manufacturing platforms using knowledge of oral drug delivery.
- Coordinate drug product deliverables with CROs/CDMOs, including pharmaceutical developability assessments and GMP manufacturing of clinical/commercial batches.
- Partner with Clinical and Supply Chain teams to forecast demand and ensure timely IMP supply.
- Oversee GMP manufacturing at CDMOs, including establishing/deploying continuous process verification (CPV).
- Support CMC regulatory submissions (e.g., INDs/NDAs) with submission-ready drug product sections and development documentation.
- Oversee CRO/CDMO activities for cGMP, FDA/ICH guideline, internal SOP, and global regulatory compliance.
- Build internal/external networks and deliver technical presentations at forums and conferences.
Qualifications
- Ph.D. or M.S. in Pharmaceutics/Pharmaceutical Sciences (or related).
- 12+ years drug product development experience in biotech/pharma with cGMP application.
- Extensive small-molecule drug product experience (formulation, process development, scale-up).
- PPQ planning/execution experience; authoring/reviewing NDA drug product sections.
- Expertise in formulation/process technologies, scale-up, and process analytical technologies.
- Experience with primary/secondary packaging technologies.
- Ability to evaluate analytical/development data and troubleshoot formulation/process/manufacturing.
- Experience managing CROs/CDMOs for GMP manufacturing.
- Experience delivering scientific posters/technical presentations.
Travel Required: Yes (Up to 30%).
Reporting to the Head of Drug Product Technical Operations, lead late-stage small molecule drug product programs, including robust and scalable drug product formulations and manufacturing processes. Focus areas include Late Stage program, PPQ, commercialization readiness, and life-cycle management.
Job Responsibilities
- Lead late-stage drug product formulation and process development, including FMEA risk assessments, QbD, PPQ planning/execution, commercialization readiness, and life-cycle management.
- Partner with CROs and CDMOs to develop scalable, commercially viable processes; troubleshoot variability and optimize performance and yields.
- Transition early-stage assets into late-stage development and commercial manufacturing platforms using knowledge of oral drug delivery.
- Coordinate drug product deliverables with CROs/CDMOs, including pharmaceutical developability assessments and GMP manufacturing of clinical/commercial batches.
- Partner with Clinical and Supply Chain teams to forecast demand and ensure timely IMP supply.
- Oversee GMP manufacturing at CDMOs, including establishing/deploying continuous process verification (CPV).
- Support CMC regulatory submissions (e.g., INDs/NDAs) with submission-ready drug product sections and development documentation.
- Oversee CRO/CDMO activities for cGMP, FDA/ICH guideline, internal SOP, and global regulatory compliance.
- Build internal/external networks and deliver technical presentations at forums and conferences.
Qualifications
- Ph.D. or M.S. in Pharmaceutics/Pharmaceutical Sciences (or related).
- 12+ years drug product development experience in biotech/pharma with cGMP application.
- Extensive small-molecule drug product experience (formulation, process development, scale-up).
- PPQ planning/execution experience; authoring/reviewing NDA drug product sections.
- Expertise in formulation/process technologies, scale-up, and process analytical technologies.
- Experience with primary/secondary packaging technologies.
- Ability to evaluate analytical/development data and troubleshoot formulation/process/manufacturing.
- Experience managing CROs/CDMOs for GMP manufacturing.
- Experience delivering scientific posters/technical presentations.
Travel Required: Yes (Up to 30%).