Associate Director of Manufacturing needed for a leading Pharmaceutical Firm
- Bay Area, CA
- Pharmaceutical manufacturing operations team
A leading Pharmaceutical Manufacturing firm committed to improving patient lives through the discovery and development of drugs is seeking an Associate Director of Manufacturing. They are looking for an individual with demonstrated experience with small-molecule APIs and drug substance manufacturing. This person will be responsible for managing a team, overseeing production activities including small molecule APIS, and providing technical support.
Ideal of Qualifications for the Associate Director of Manufacturing include:
- 5+ years' experience in a heavily regulated pharmaceutical, biotech or other cGMP regulated environment preferred
- Small molecule API experience required
- Outsource manufacturing experience a plus
- Customer relationship experience
- Extensive experience in commercial manufacturing and development of late phase small molecule Active Pharmaceutical Ingredients (APIs).
- Expertise in process development, process validation and commercial manufacturing of small molecule API. Familiar with Quality Risk Assessment, Design of Experiments, Proven Acceptable Range studies and application in late phase drug product development.
- In-depth knowledge of US and EU regulatory requirements for cGMP
- Bachelor's Degree required; Scientific, engineering, or other technical field of study strongly preferred
- LEAN and/or Six Sigma experience a plus
- Ability to travel 15-25% of the time
Responsibilities for Associate Director of Manufacturing include:
- Manage partnerships and relationships relevant to the CMO
- Oversee all activities within the small molecule API manufacturing environment
- Monitor production activities to ensure compliance with cGMP, FDA and other government and regulatory guidelines
- Provide technical support and conduct root cause analysis while troubleshooting potential issues
- Develop, implement, and uphold operational KPIs and SOPs to ensure maximum safety & quality standard on the plant floor
- Collaborate with R&D, Engineering, Quality, and other necessary parties
- Lead process development, manufacturing, change control, troubleshooting manufacturing issues, investigations, and resolution of deviations as small molecule API products transition from Phase 2 to Phase 3 and validation at CMOs.
- Collaborate with cross-functional CMC team in Supply Chain, Quality, Regulatory, Legal & Finance