DIRECTOR, BIOLOGICS MANUFACTURING(Job Number: 1203344)
The Syracuse Biologics Manufacturing operation produces clinical, commercial and launch biologics drug substance at its 5000L scale manufacturing facility (mammalian cell process) in Syracuse, NY. The Director, Biologics Manufacturing is responsible for all components of the manufacturing operations organization, which include: Cell Culture and Purification. Drives resources to address priorities, meet production schedules, maximize productivity, reduce costs, and increase efficiencies through continuous improvement strategies. Develops and leads a high performance management team responsible for commercial manufacturing, directs the recruitment and development of manufacturing staff. Invests in the development of current and future leadership through assignment of development opportunities, coaching, mentoring, and effective administration of rewards and recognition. Establishes and communicates business objectives for manufacturing, consistent with company biologics strategy. Establishes and communicates high performance standards, defines clear accountability, and leads by adopting continuous improvement strategies to reduce operational variances and reduce cycle time. Sets high standards for compliance to meet and exceed regulatory agency requirements related to biologics manufacture and assure compliance with BMS Directives including safety, training, cGMP, quality systems documentation, change control, operational variance, and failure investigation. Develops annual operating budget/staffing levels and manages operation to achieve the financial objectives. Participates actively on the site Senior Leadership Team to establish site mission, annual goals and desired culture while undertaking supportive actions which build commitment to these values, objectives and sustained site-wide teamwork.
A Ph.D. or M.S. in the field of biochemical engineering, chemical engineering, biochemistry, or appropriate technical discipline. A minimum of 10-15 years of successful managerial experience in cGMP biologics manufacturing with a documented history of technical accomplishments. An in depth knowledge of regulatory requirements for filing biologics in the US and Europe. Knowledge related to mammalian cell bank, cell culture and purification manufacturing as well as in depth knowledge of validation for a biologic manufacturing facility. Demonstrated success as a strong team leader who uses past management and supervisory experience to develop departmental staff through effective feedback and coaching. Proficiency in developing and managing departmental budgets. Excellent organizational skills and the ability to successfully manage multiple technical projects and priorities, excellent analytical and strategic thinking skills and experiences with Lean Six Sigma tools. Direct experience with supporting 24/7 manufacturing operations is preferred.
Job Function: Manufacturing Operations
Primary Location: NA-US-NY-Syracuse
: Tech Op - Other
- 3 years ago - save job