Bristol Myers Squibb Associate Director/Gp Leader Upstream Process Development in Hopewell, New Jersey
Associate Director/Group Leader Upstream Development
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.
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.
Bristol-Myers Squibb has consolidated process development organization comprising Molecular biology, Cell Line Development, Upstream and Downstream development, and Process Analytics collocated with a large Analytical Development organization in Hopewell, New Jersey. BMS’ Hopewell site is part of New Jersey's “Biopharmaceutical Life Sciences Cluster,” a concentrated area of biotechnology, medical device, and pharmaceutical companies.
This position will lead and advance upstream cell culture development sciences and is one of the key leadership roles in the Biologics Process Development in New Jersey. The role will report to the Site Director of Biologics Process Development and will be based in Hopewell location near Princeton, NJ. Specifically, the role will lead the Upstream Development group responsible for process development of multiple therapeutic antibody and recombinant proteins, and establishment of a next generation platform for upstream development enabling cutting edge immune-oncology and other biologics programs.
The candidate will lead internal and partnered projects and will be part of a team driving high performance across upstream development in the network. The candidate will actively partner with the Cell Line Development and Downstream team, Drug Product Science & Technology, Late Stage Process Development, Manufacturing, Analytics, Project Management, and Research & Development groups in a matrix, team organization to achieve a seamless and platform upstream process approach. The position needs a proven leader to drive the science to realize significant opportunities in upstream process especially as those relating to incorporating omics technologies. This is a large impact position and the candidate will be a member of the leadership team of the Biologics Process Development organization in NJ and works with a group of peers in the larger network constituting a benchmark biologics development organization.
• Provide all aspects of upstream process development support (see below) to ensure success of matrixed project teams.
• Partner with matrix Development and Clinical Manufacturing organizations to ensure seamless transition and transfer of processes. Coordinate experiments with matrix teams to ensure rapid achievement of objectives and overall process transfer goals.
• Implementation of novel upstream including continuous manufacturing approaches to enhance BMS’ competitive advantage.
• Drive continuous process improvements for the group and matrix organizations.
• Manage capital and budget requests and equipment acquisition.
• Provide performance feedback, coaching, career development and mentoring to each team member to ensure their success and fulfilment.
Responsibilities of Upstream Group:
• Design and set the agenda for a high performing upstream development team.
• Develop and guide the technical agenda for multiple protein therapeutics platform upstream processes and expand as needed in new modalities including gene and cell therapies.
• Implement upstream process development, optimization, scale-up of biologic manufacturing processes and support as needed process characterization and PPQ activities.
• Coordinate with Process Development Analytics team for rapid analysis support.
• Drive new technology initiatives via intra and inter-departmental and external collaborations, and guide the necessary experiments for evaluation and implementation.
• Lead project and matrix team meetings and coordinate activities for the project team with other process development focus groups.
• Write technical project reports and lead program reviews on a regular basis in matrix organization.
• Perform and communicate research within BMS and in collaboration with technical institutions to achieve the desired next generation process development goals.
• Write and review technical manuscripts for publication and intellectual property documents.
The successful candidate will have:
• PhD in Chemical/Biochemical Engineering, Biotechnology, Microbiology or Biochemistry or related fields.
• Minimum of 10 years of experience in Process Development/Upstream Process Development.
• Track record of successful implementations of a robust upstream process from development to a commercial setting.
• Track record of demonstrable management skills of multiple projects and technical teams.
• Experience with all aspects upstream process development including Fed-batch and perfusion processes.
• Knowledge of design of experiments and use of statistics for data analysis.
• Demonstrated experience in technical transfer of processes.
• Experience with scale up and scale down.
• Experience with manufacturing organizations and commercial manufacturing organizations.
• Understanding of established and current trends of ICH and regulatory agencies.
• Effective oral and written communications
• Critical thinking skills and problem solving ability
• Skilled at working with teams and delegating tasks
Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.