Director Manufacturing

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 Clark at 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.