Director of Manufacturing - Permanent - San Francisco Bay Area, CA
Proclinical are partnered with a leading pharmaceutical company who are seeking a Director of Manufacturing.
Primary Responsibilities:
This role involves managing Contract Manufacturing Organizations (CMOs) to produce solid oral dosage forms for late-phase clinical programs and commercial supply.
Skills & Requirements:
- Significant experience in manufacturing and development of small molecule solid oral dosage forms, including both internal manufacturing and managing CMOs.
- Knowledge of Quality Risk Assessment and regulatory requirements for cGMP in the US and EU.
- Proven track record in managing CMOs for late-stage development.
- Strong project management and analytical skills.
Education & Experience:
- Bachelor's, Master's, or PhD in a relevant scientific discipline.
- 10+ years in pharmaceutical development and outsourced manufacturing, particularly with solid oral dosage forms.
The Director of Manufacturing's responsibilities will be:
- Oversee manufacturing activities at CMOs, serving as the main point of contact and providing on-site support.
- Lead process development, validation, and technology transfer, resolving manufacturing issues as products progress through clinical phases.
- Design and analyze protocols for process optimization and develop metrics for continuous improvement.
- Collaborate with Supply Chain, Analytical, and Quality teams to ensure compliance and align manufacturing schedules.
- Review and approve essential documentation related to product development and manufacturing.
Compensation:
- $210,000 to $270,000 per annum
If you are having difficulty in applying or if you have any questions, please contact Annabelle Clarkat a.clark@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.