Associate Bioengineer II

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Summary:

The Associate Bioengineer II works within a larger Cell Therapy development team to support the process development and life cycle management of a commercialized cell therapy. Collaborate within a cross-functional team to analyze manufacturing data and trends, troubleshoot manufacturing issues and provide expertise for investigations. Design, perform, and interpret experiments for the ongoing improvements to the manufacturing process which include: closure of open systems and evaluation of secondary vendors for raw materials and the clinical administration process. Be accountable to stakeholders and peers for smooth day-to-day operation of the cell culture laboratory and communicate with collaborators.

Responsibilities will include, but are not limited to, the following:

• Assist with troubleshooting activities
• Review batch documentation, extract relevant data, and communicate findings
• Assist in the development, updating, and review of procedures and executed records
• Provide Subject Matter Expert (SME) support in training of manufacturing and QA personnel as well as tech transfers
• Interact with other CMC teams including Manufacturing Operations, QA, Development, and Regulatory
• With minimal supervision, design and execute/implement cellular process development, characterization, and optimization studies on one or more of the following areas: cell culture, cell harvesting, immuno-selection, tissue processing, cryo-preservation, phenotyping, transduction, cell delivery, infusion, etc.
• Design well-controlled experiments, perform data analysis, and summarize empirical results, with moderate technical/scientific supervision and feedback
• Manage inputs in real-time into databases
• Applying knowledge of statistics and mathematical modeling of process development and clinical manufacturing data
• Support process changes and implementation by routing change requests and rewriting procedures and executed records
• Ensure proper operation and perform routine maintenance of all laboratory equipment
• Assist other staff to complete all laboratory tasks as necessary
• Maintain a safe work environment in accordance with policies/procedures/regulations
• Position based in Warren, NJ with frequent site visits to Summit NJ Manufacturing and potentially to Seattle/Bothell WA (infrequently) for Tech Transfer work

Skills/Knowledge Required:

• B.S. in Biochemical, Chemical, or Biomedical Engineering or Cell Biology/Immunology related discipline with 3-6 years of relevant process development experience or M.S. with 1-3 years of relevant experience
• Must be competent and confident in mammalian cell culture and aseptic technique
• Must have excellent organization skills and ability to handle multiple tasks
• Highly motivated, willingness to acquire new skills and ability to work with minimal operational supervision
• Must have engineering or scientific knowledge appropriate for cellular process development
• Experience working in or supporting a regulated environment would be advantageous
• Excellent verbal and written communication skills
• Must be proficient in statistical data processing software such as JMP, Minitab, or Excel
• Ability to review, interpret, and disseminate relevant

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.