External Manufacturing Manager
Apex Life Sciences has a permanent opening for External Manufacturing Manager for Our Client, a groundbreaking pharmaceutical company, located in Oregon. The successful candidate will be responsible for the day-to-day management of an expanding Contract Manufacturing Organization (CMO) supply chain and therefore must have experience with external vendor management.
Description of Duties:
- Provides technical expertise in management of a pharmaceutical manufacturing supply chain from drug substance to drug product to packaging and delivery to customer.
- Identifies project risks and gaps and works to mitigate those risks.
- Communicates effectively and transparently with functional heads within Pharmaceutical Development, Quality, Regulatory, Project Management and Operations.
- Communicates effectively and productively with responsible team members from manufacturing partners (CMOs).
- Provides on-site support during active manufacturing at vendor locations
- Addresses problems and deviations as they arise at the manufacturing sites and assists in implementing corrective and preventative actions.
- Prepares and presents documentation for BARDA communications and internal management reviews.
- Works closely with Our Client’s Project Management Team in the reporting of supply chain status.
- Evaluates CMO performance, reviews batch manufacturing records, deviations and investigations.
- Maintains understanding of current trends in drug product manufacturing and engineering research.
- Maintains understanding of current FDA guidance related to CMC activities.
- Attends regularly scheduled meetings with Our Client’s Customer(s), upper management and internal project teams.
- A minimum of five years of pharmaceutical supply chain experience including commercial production
- Advanced Degree in pharmaceutics, chemical engineering, chemistry or a relevant field.
- Broad knowledge and experience with regulatory requirements including ICH, FDA and compendia USP, JP, EP.
- Experience in preparing data for presentations and publications.
- Management experience in a pharmaceutical / biotech industry setting.
- The ability to function in a fast-paced, high-growth, entrepreneurial environment.
- Strong regulatory knowledge of drug development, CMC, preclinical and clinical requirements.
- Experience with antiviral or anti-infectious drugs a plus.
- Travel domestically and internationally will likely be required.