Process Engineer

Profile

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.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com