Our client is a mid-sized public company with approved products already on market. Located in the suburbs of Boston & Cambridge, they are growing their in-house Supply Chain team to support the development of solid, liquid oral dosage forms for use in clinical studies and potential commercialization of pipeline products.
The main function of this role is to manage all aspects of the clinical drug supply chain, including creation, execution and maintenance (by forecasting) of the clinical drug supply strategy and associated budget management. This position will also serve as a liaison between the CMC and clinical teams and and work cross-functionally with the clinical/CMC team members and CMO/CRO/partners.
Responsibilities include but are not limited to;
• Identify, evaluate, request proposals and select appropriate CMOs for packaging, labeling, and distribution to build a robust supply chain and ensure uninterrupted drug supply for global clinical trials.
• Manage storage and distribution (Cold chain and controlled room temp) of clinical trial materials via primary and secondary depots.
• Work with cross-functional teams and CMOs to develop and approve compliant country label text.
• Forecast the amount of drug needed for ongoing clinical trials and manage inventory of labeled supplies based on drug product expiry.
• Serve as SME to provide drug product related information to set up systems for new protocols and maintenance of existing protocols, management of threshold levels, generation of manual shipments and disposition of quarantined materials, as needed.
Formal descriptions can be supplied for interested candidates.
Qualified candidates will have a BS degree or higher and 3-5+ years of experience in managing Phase 1 through Phase 3 global clinical supply chain in Life Sciences. Additional Project Management Training (PMP) would be beneficial and experience with combination drug products in various global markets would be a plus. Must have experience managing vendors with strong understanding of regulatory requirements and guidelines governing labeling, packaging and distribution of clinical trial materials US/EU/ROW and Global country requirements (FDA/EMA/ICH) and knowledge of proper GMP/GXP trial documentation. Understanding of the complete Drug Supply Chain: Drug Substance/Drug Product/Regulatory Submissions and steps required for compliant Drug Release approvals and Global Importation logistics process is a plus.
Must be authorized to work in the US to be considered and must be commutable to the Cambridge/Watertown area or able to relocate with limited assistance.
All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.