- Work cross-functionally with Global CTMs and study teams to drive and maintain forecasting projections of Clinical Materials, Drug Product, and Drug substance in support of our global studies.
- Conduct planning and forecasting for clinical programs. Schedule and implement labeling, packaging, and Quality release operations with the CMO and cross-functional Mirum to ensure continuous clinical supply.
- Defines and develops appropriate packaging components and shipping configurations for products. Oversees and coordinates packaging and labeling activities.
- Develop and/or implement and/or oversee drug supply tracking systems.
- Tracks and manages inventory of GMP products including drug substance, drug product, product retains and ancillary supplies for Mirum’s clinical trial program in compliance with GMPs.
- Author & oversee reports, metrics and presentation to internal stakeholders on study team and management regarding clinical supply chain status.
- Coordinate shipments between distributors, to depots and sites. Provides follow-ups to shipments and help troubleshoot shipment problems.
- Identifies gaps and risks associated with packaging, labeling and distribution of the drug product. Partners with internal stakeholders to proactively manage risks.
- Develop processes and systems, draft corresponding SOPs.
- Receive excursion/deviation reports. Oversee investigations in collaboration with Quality, CMO and sites.
- B.A./B.S. preferred. 5+ years of experience in Pharmaceutical operations and supplier management functions.
- Must have previous experience with pharmaceutical, clinical supply operations.
- Drug Supply Management skills in multidisciplinary environment with complex strategies and geographical specific requirements and ability to adapt to changes
- Experience in a small company environment preferred.
Knowledge, Skills and Abilities:
- Proven ability to lead complex contractual negotiations with a deep understanding of financial considerations when it comes to procurement and supply chain.
- Understands and wants to work in a small company environment and is a “doer”.
- Proactive, shows good judgment, anticipates future consequences and can make decisions decisively in the face of ambiguity.
- Can apply knowledge to new situations.
- Creates a sense of partnership with vendors, but can be direct when needed.
- Thinks outside the box, and come up with creative solutions when faced with challenges.
To apply, please send your resume to firstname.lastname@example.org.