Scientist/Engineer I/II

Manufacturing/Ops

icon-location-marker Devens - MA - US
Posted 45 days ago Full_time R1520391

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.

Scientist/Engineer I/II Bioprocess Technology MS&T

Serves as a process technical lead and subject matter expert to small/large scale cell culture and harvest unit operations for the commercial manufacture of biopharmaceuticals at Devens manufacturing.

The successful candidate will be key contributor to a dynamic and highly technical team of engineers and scientists by setting appropriate objectives and priorities, overcoming obstacles; and delivering results within project timelines and will build and maintain effective collaborations with Manufacturing, Manufacturing Support, Process Development, Quality Assurance, Analytical and Global Regulatory Sciences groups. Strong communication and technical writing skills are required. The incumbent will lead the design and execution of experiments for design & control of large scale inocula, seed train, bioreactor, filtration and centrifugation unit operations. Appropriate GLP/GMP procedures must be followed. This position also involves troubleshooting and problem solving of process related problems observed at manufacturing scale and the evaluation of new process technologies through the effective design of scale-down studies and the evaluation of data from manufacturing lots. 

  • Demonstrates breadth of knowledge in cell culture development and operations with the ability to apply this knowledge to the design, implementation and interpretation of experiments.
  • Provides technical expertise for investigation and resolution of upstream process deviations, root cause investigation, CAPAs, process improvements, scale-down model development, new technology evaluation and preparation of regulatory filings
  • Demonstrates a strong knowledge of cGMP compliance, BMS corporate, site and regulatory agency requirements and procedures
  • Supports process technology transfer, process validation and the preparation of CMC documentation for regulatory filings for BMS Devens Cell Culture facilities
  • Authors technical documents, including protocols, reports and SOPs supporting the validation of the manufacturing upstream process
  • Participates in the preparation of regulatory filing documents and inspection readiness
  • Provides process subject matter expertise for regulatory inspections and other interactions with regulatory agencies, representing the Devens site

Qualifications:

  • B.S., in the biological sciences or chemical/biochemical engineering, a related discipline, or its equivalent. Graduate education through M.S. or PhD highly desired
  • Minimum BS or equivalent with a minimum 6-8 years relevant experience, MS or equivalent with minimum of 4-6 years relevant experience, PhD with 0-2 years relevant experience in upstream manufacturing, technical support or upstream process development in the biopharmaceutical industry
  • Experience in contributing to the design, modification and optimization of cell culture or fermentation unit operations
  • Proactively identifies problems and troubleshoots solutions
  • Organizes and presents data for internal/external scientific meetings
  • Works independently, in teams and collaborates with other groups in a matrix environment
  • Leverages emerging trends in biotechnology to solve complex problems
  • Capable and willing to train others on procedures, operations, new technology, methods or processes

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.