The Director, Biologics Third Party Manufacturing Project Management manages the interface between BMS and third party vendors that support the development and manufacture of BMS biologic portfolio. They are responsible for managing a wide range of technically diverse activities and projects that include technical transfer of early phase projects, process and methods development, process characterization studies, scale-up, validation, CMC inputs for regulatory filings, launches, and routine commercial manufacturing.
Responsibilities span the full spectrum of BMS development program stages. Work involves internal and external contacts. The Director organizes the program of work across the internal matrix which includes Process Sciences, Manufacturing Sciences & Technology, Analytical Development and Testing, QC, Third Party QA, QC, and Supply Chain & Operations Planning. They will set both strategic and project specific technical objectives across the matrix. In addition, they ensure that the vendor has adequately resourced projects and are maintaining commitments for milestones. Having the responsibility for performance outcomes at third party vendors, considerable judgment and initiative is required to manage the scope of work and to solve problems that arise as the consequence of project execution. The impact of their decisions has significant impact on both clinical and commercial supply chain, and as such, the business performance of the company.
The Director is the first line BMS ambassador with external vendors and is responsible for maintaining good business relations. The Director is also responsible for establishing and monitoring the budgets for each project managed at the third party. The Director works closely with both Global Procurement and SC&OP on business aspects which include negotiation, execution, and maintenance of business contracts. The Director typically manages several key biologic projects in late stage development or commercial phases.
Typically, the Director is responsible for 3 or more projects, although, the number can be less based on the complexity of the program of work. The third party vendors are a mix of both domestic and international companies. The Director is accountable for the outcomes of these programs.
· A Ph.D. in biological sciences, engineering, analytical chemistry or process sciences with 10 years of experience; or, a MS in biological sciences, engineering, analytical chemistry or process sciences with 15 years of experience is required.
· Industrial experience in drug development and manufacturing of biologics with a strong history of technical accomplishments which include leading technical teams in a highly matrixed environment is essential.
· Strong knowledge of regulatory requirements related to key markets is also required. The individual should have excellent communication skills with the ability to provide key messages at all levels within the internal and external organizations.
· Excellent interpersonal, collaborative, and team building skills.