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Senior Process Engineer CAR T at (BMS) Bristol-Myers Squibb in Summit, New Jersey

Posted in Manufacturing 30+ days ago.

This job brought to you by eQuest

Type: Full-Time





Job Description:

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.

Job Purpose / Position Summary

Bristol-Myers Squibb is developing novel cellular immunotherapies based on two distinct and complementary platforms – Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies. Our goal is to revolutionize medicine by re-engaging the body’s immune system to treat cancer.

We are looking for a Senior Bioengineer to join the Comparability Team within the Cell Therapy GMSAT (Global Manufacturing Science and Technology) department.  The successful candidate will collaborate with the GMSAT teams in Seattle and New Jersey locations in the US and support efforts related to tech transfer and lifecycle management. The Senior Bioengineer will be responsible for leading cross-departmental teams, and planning/executing risk assessments and strategy development for analytical comparability exercises to enable change implementation.  This role is responsible in developing study design and statistically derived criteria to evaluate pre-change and post-change results and summarize the strategy in technical protocols and results in technical reports.  This person will collaborate across all CMC functional areas to insure project advancement, rapid and best in class execution, and communication of challenges/opportunities.  The Senior Bioengineer will play a key role in product lifecycle management, including development, characterization, commercialization, and evolution of cell therapy products. 

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


  • Collaborate with process engineers and analytical scientists and  guide comparability design by applying in-depth CAR-T and viral vector manufacturing process knowledge

  • Perform statistical analysis of product attribute data as well as statistical tests and evaluation to assist the design and execution of comparability exercises for cell therapy and vector products

  • Lead execution of process risk assessments, development of criteria justifications, and development of comparability protocols

  • Author regulatory filings summarizing the strategy and results from comparability exercises

  • Develop, understand, and manage tools and templates that can be used to quantify potential impact of changes on process performance and product quality

  • Lead efforts focusing on alignment and harmonization of comparability strategies across multiple sites

  • Leverage and maintain strong relationships across multiple sites

  • Coach/support junior staff on the team on complex technical issues

  • Up to 50% travel my be required (primarily domestic travel)

Skills/Knowledge Required:


  • B.S. or M.S. in Chemical Engineering, Biochemical Engineering or equivalent with 2-5 years relevant experience in biologic process/analytical development or commercial biologic or vaccine manufacturing process technical support

  • Demonstrated ability to effectively work in cross functional teams, meet deadlines, and prioritize multiple projects working in a self-driven, performance/results oriented, fast paced matrix environment

  • Demonstrated ability to perform/document complex manufacturing processes and provide technical support in a clinical/commercial GMP environment

  • Experience in development and/or characterization of biologics and/or cell therapy manufacturing processes

  • 2+ years of experience working in a GMP environment, ICH guidelines, control strategy development, and working within a Quality organization

  • Excellent problem solving skills

  • Proficiency utilizing MS Office products and statistical software (R, JMP, Minitab)

  • Able to creatively manage time and elevate relevant issues to project lead and line management

  • Strong scientific and technical writing

  • Detail oriented with excellent verbal and written communication skills

Additional Skills:


  • Preference given to candidates with experience writing regulatory submissions

  • Knowledge of cellular immunology a plus

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.