Clinical Supply Manager
Alkahest is seeking a Manager, Clinical Supply with experience in the pharmaceutical or biotech industry. You will manage clinical supply chain oversight and logistics for biologics and new chemical entity programs. The ideal candidate will have a background specific to pharmaceutical or biotechnology products, and the unique supply chain challenges present in a GMP environment.
- Support clinical study teams with study drug supply; demand, forecasting, and logistical planning for all clinical trials
- Lead and direct partnership with drug suppliers - manage relationships as well as forecasting and demand planning
- Support project total drug supply forecasting activities, including lot allocation activities
- Creatively seek out ways to improve the supply chain process
- Ensure that supply chain operates within the context of our contractual obligations
- Work closely with CMC and Quality group for production input into the supply chain, as well as to ensure release of product domestically and internationally
- Provide expertise with packaging technologies
- Review and resolve all shipment issues (damage, temperature excursions, non-compliance). Analyze root cause and design solutions to resolve recurring problems, including deviation and CAPA ownership.
- Manage relationships with vendors as needed, including managing quotes, purchase orders and invoicing
- Assist Finance with inventory reconciliation, forecasting and financial close
KNOWLEDGE AND EXPERIENCE
- A Bachelor’s degree in business or biological sciences required, Supply Chain Management or related discipline preferred
- Minimum of 5 years of planning experience in a combination of clinical supply chains in biotech/pharmaceutical industry
- Working knowledge of cGMPs and pharma industry procedures and regulations
- Theoretical and practical knowledge of clinical supply forecasting, demand planning and manufacturing capacity management
- Knowledge/proficiency as Master Production Scheduler/Planner
- Ability to anticipate/define problems, collect and analyze data, draw valid conclusions and execute corrective actions and preventative measures
- Global release and distribution logistics and cold chain experience is required
- Must possess import/export expertise including customs, transportation, and regulatory guidelines.
- Strong interpersonal skills and the ability to work independently, as well as a member of a team
- Must have exceptional verbal, written, presentation, communication and negotiation skills
- Proficiency with: Microsoft Word/Excel/PowerPoint/Project software