Associate Director, MS&T Upstream
Company: Bristol-Myers Squibb
Location: Syracuse, New York
Posted: August 13, 2017
Reference ID: 1703205
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.
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.
Our Syracuse site supports the production of biologics products across the extensive Bristol-Myers Squibb manufacturing network, including molecules from clinical trials through commercial launch at sites around the globe.
Syracuse MS&T is seeking a permanent Associate Director, Upstream (AD USP) for our Syracuse, NY site. The successful candidate will direct the design, execution, and interpretation of cell bank, inoculum, and cell culture experiments to support large-scale biopharmaceutical cGMP commercial manufacturing and next generation processes within the Syracuse Biologics Drug Substance MS&T department. The successful candidate will lead a dynamic and highly technical team of engineers and scientists by setting appropriate objectives and priorities, overcoming obstacles, and timely delivering results. DS MS&T participates in cross-functional teams and works independently to meet highly visible, critical business objectives.
Major Duties and Responsibilities:
·Accountable to optimize resources for the design, execution, and analysis of cell bank, inovulum, and cell culture experiments, to complete the execution of the experiments and the interpretation of the studies.
· Sets high standards to assure compliance with BMS Directives including safety, staff training, cGMPs, and quality systems documentation.
· Represents the Syracuse site and MS&T during regulatory agency inspections in Syracuse and across the manufacturing network. Routinely liaises with MS&T Process Champions, Biologics External Manufacturing, Syracuse Manufacturing, and Syracuse Manufacturing Technology regarding strategies for technical and operational improvements, investigation resolution, process validation, and laboratory troubleshooting.
· Invests in the growth of the group, including current and future leadership, through assignment of development opportunities, coaching, mentoring, and administration of rewards and recognition.
· Establishes business objectives for the group that are consistent with BMS’ biologics strategy. Establishes high performance standards, defines clear accountability, and leads by developing, adopting, and supporting continuous improvement.
· Actively communicates group’s activities and progress through varied technical and non-technical forums.
Knowledge and Skills
• Ph. D. or equivalent experience with over 10 years directly related industry experience, documented by a solid history of technical accomplishments in fermentation or cell culture process development, technical transfer, and manufacturing technical support.
• Experience in the design, modification, and optimization of fermentation and cell cultures, with a strong practical knowledge of the related technologies and clear awareness of current industry trends.
• Experienced in development and technology transfer of processes for late-stage and commercial biologic manufacturing.
• Excellent verbal and written communications skills.
• In-depth knowledge of regulatory requirements for filing Biologics in the US and Europe including past interactions with US and European regulatory agencies for the development and manufacture of biologics.
• Direct involvement in a BLA, sBLA, or MAA regulatory filing and the subsequent PAI.
• The Associate Director reports to the Director of MS&T and is in direct contact with other senior leaders, including members of Process Development, Analytical, Quality, EH&S, and Manufacturing.
• A frequent interaction with stakeholders on other BMS sites and external industry and regulatory representatives is expected.
• Assignment is in Syracuse, NY.
• The Associate Director is expected to have a strong presence in the lab and balance time between the lab and office, based on business priorities.
• Occasional business related travel is required, not generally exceeding 5 nights per quarter.
• The successful candidate will be a decision-maker.
• Works on complex problems in which analysis of situations or data requires an in-depth evaluation of multiple factors.
• Typical activities include problem solving of process-related investigations, the preparation of study protocols and reports, the evaluation of new process technologies through the use of scale-down models, in-depth understanding of data from manufacturing, development of resourcing models.
• Ensures budgets, schedules, and performance requirements are met.
• Works with minimal supervision on the accomplishment of goals and objectives.
• Establishes objectives and assignments and delegates appropriately.
• Supervision will include 3-5 direct employees, 9-12 total permanent employees and contractors.