Bristol Myers Squibb Company

Process Engineer

Location
Celgene, NJ, United States
Posted
Sep 15, 2020
Ref
R1522205
Required Education
Bachelors Degree
Position Type
Full time
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.

At Bristol-Myers Squibb, we are committed to changing the course of human health through bold pursuits in science, life-enhancing therapies and a promise to always put patients first. Our Manufacturing Science and Support team, part of our Cell Therapy Development and Operations organization, is a highly collaborative, skilled group of individuals who deliver value daily to the production of Bristol-Myers Squibb's products.

To continue to do this important work, we are hiring a Bioengineer/Scientist in the Manufacturing Science and Support Group. Please join us!

Description

This is an engineer/scientist position within the CAR T Manufacturing Science and Support group. The position will be responsible for the process transfer of the new pipeline products from Research/Development to Clinical Manufacturing within Bristol-Myers Squibb's Cell Therapy Development Organization. This role is also responsible for manufacturing support, personnel training, writing procedures/protocols/reports, designing & executing experiments, trending manufacturing data and leading manufacturing troubleshooting. Activities will be performed in accordance with cGLP/cGMP regulations, established business processes and protocols, and applicable standard operating procedures. The qualified candidate should have work experience in process development for cell therapies/biologics, strong knowledge in cGMP of cellular products/biologics and a solid understanding of the fundamentals of tech transfer, process development & characterization, and manufacturing science.

Responsibilities will include, but are not limited to:
  • Perform early stage process transfer from Research/Development to Clinical Manufacturing.
  • Write & review procedures, protocols, and reports.
  • Work as a process SME to support clinical manufacturing, troubleshooting, training, deviation investigations and identify appropriate CAPAs.
  • Perform manufacturing data trending to contribute to the lifecycle management of a process.
  • Contribute to IND documents and provide necessary technical input to support regulatory discussions.
  • Design and execute laboratory experiments.
  • Perform process risk assessment.
  • Support process changes during the lifecycle.
  • Train end-users and entry-level personnel on the manufacturing process.
  • Maintain knowledge of scientific literature & regulatory guidelines and apply key concepts to project activities/plans.


Minimum requirements/Qualification
  • B.S. in Biochemical Engineering or related discipline with 7+ years, or MS with 4+ yrs of process development experience for cell therapies or biologics.
  • Strong grasp and application of engineering fundamentals pertaining to immunotherapy process development.
  • Experience working in a GMP regulated environment. Knowledge of cGMP and an understanding of the concepts of GLP, good clinical practices and FDA guidelines related to cell therapies/biologics.
  • Understanding of cell culture techniques and sterile practice.
  • Ability to work with minimal technical supervision and perform operational tasks independently.
  • Strong verbal and written communication skills and interpersonal skills.
  • Highly motivated and driven to acquire new skills.


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.