Engineer / Scientist - MST Downstream

Manufacturing/Ops

icon-location-marker Devens - MA - US
Posted 67 days ago Full_time R1520998

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.

ENGINEER / SCIENTIST – MS&T DOWNSTREAM

The Engineer / Scientist Manufacturing Sciences & Technology Downstream serves as a technical lead and subject matter expert in the areas of purification and primary recovery, including mixing, chromatography, viral clearance, ultrafiltration/diafiltration, filtration, formulation, and primary recovery unit operations, to support late-stage and commercial manufacturing of biologics drug substance.

The successful candidate will be a key contributor to a highly technical, diverse, and collaborative team of scientists and engineers. MS&T scientists and engineers contribute to cross-functional teams to meet highly visible business objectives. Deliverables include manufacturing process support, characterization of next-generation processes, process technology transfer and validation, submission of regulatory filings, and technical leadership during interactions with health authorities.

This position offers the opportunity to interface with Manufacturing, Manufacturing Support, Process Development, Quality Assurance, Analytical, and Global Regulatory Sciences groups. 

Responsibilities:

  • Lead the design and execution of experiments in purification and primary recovery unit operations for the investigation and resolution of process deviations in the Large-Scale Cell Culture and Single-Use Facilities at the Devens, MA site through the effective design of bench and pilot scale-downs studies and the evaluation of data from manufacturing lots.
  • Technical support of drug substance handling and cryogenics operations at Devens may be required.
  • This position is based at the Devens site and may provide technical support to additional sites within the internal or external manufacturing network.
  • Provide technical expertise for root-cause analysis, corrective and preventative actions (CAPA), process improvements, and scale-down model development.
  • Author and review technical documentation, including validation protocols and reports and multilayered impact assessments.
  • Lead process characterization and initial scale-up for intensified processes and integrated analytical technologies in collaboration with Process Development, Analytical, and Operations groups.
  • Contribute to regulatory filings and inspection campaign readiness activities.
  • Provide process subject matter expertise, representing the Devens site, during inspections and other interactions with regulatory agencies.
  • Demonstrate a strong knowledge of cGMP compliance, BMS corporate, site, and regulatory agency requirements and procedures.

Qualifications:

  • PhD or MS in Chemical/Bio Engineering, Biochemistry or related field with 0–2 or 4–6 years, respectively, of relevant industrial and/or academic experience. 
  • Knowledge of protein purification, protein stability, and demonstrated experimental skills for laboratory work are required.
  • Experience with AKTA purification and ultrafiltration/diafiltration operations is helpful.
  • Critical qualities include a high degree of curiosity and initiative, good verbal and written communication skills, strong scientific skills and attention to detail, and the ability to work independently and in a team environment.
  • Interpersonal and facilitation skills are necessary to interface with and influence across levels of the organization.

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.