Senior Manager of Supply and Manufacturing

 

Key Job Responsibilities:Management of the supply chain to ensure timely delivery of product to multiple destinations. Balancing the interface between supply and demand, through a sales and operational planning process, while minimizing stock and working capital.  Design, implementation, validation and operation of the supply chain, including the cold chain storage and distribution of drug substance and drug product to multiple domestic and international subcontractors. Selection and management of supply chain subcontractors for distribution and storage, to ensure we have a compliant and efficient supply chain. Oversee the clinical supplies group, responsible for managing drug product supply to clinical sites in accordance with standard procedures and agreements with subcontractors, for reconciling all materials in the supply chain and clinic, and for movement and storage of clinical blood samples.  Selection and management of external fill finish CMO’s including technology transfer of processes between the CMO’s. Management of the interfacing schedules between the CMO activities and subcontractors. Progress monitoring of CMO activities, and the provision of updates for communication to the NIH, including monthly reports, weekly progress reports and master Gantt and risk register updates. Coordination of all communication with the external CMO’s, including conference call facilitation, action item follow up and issue resolution.



Job Knowledge Required:Position requires a BS degree Position requires 3 to 5 years production or supply chain experience preferably in cGMP Pharmaceutical industry Position requires experience in project management of large complex projects and in manufacturing management Position requires experience with the management of a clinical supply chain for at least 2 other products Position requires experience in understanding the needs of the clinic and of the developmental activities

Equal Opportunity Employer.

Avecia is the world leader in the development and manufacture of cGMP oligonucleotides for therapeutic applications. As one of the first companies established to serve this market, Avecia has over 10 years' experience in DNA, RNA, siRNA, Chimeras and Molecular Decoys. Our FDA-registered DNA Medicines facility, located in

Milford, Massachusetts, manufactures Active Pharmaceutical Ingredients (API) at a range of scales. Our quality systems assure that all materials used meet agency (FDA) regulations and patient safety requirements.