Director Manufacturing job in San Francisco, USA

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Job type: Permanent

Discipline: Manufacturing

Location: United States

This vacancy has now expired. Please see similar roles below...

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.