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Bristol Myers Squibb: Scientist, Cell Therapy Process Development

Bristol Myers Squibb

This is a Full-time position in Seattle, WA posted December 27, 2020.

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science.

In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change.

We bring a human touch to every treatment we pioneer.

Join us and make a difference.

PURPOSE AND SCOPE OF POSITION: Key contributor to all aspects of a commercial platform cell therapy process, including process development, redefining processes to achieve improved characteristics, process characterization, data analysis, life cycle and stake holder management, report writing, and regulatory filing activities.

Make contributions related to various aspects of cell therapy process development including cell collection/isolation, cell expansion, medium design, harvest, formulation, and cryopreservation, as well as coordinate, supervise, influence, and advocate for scientific and technical staff.

Contribute to the success of a complex and evolving cross-functional lifecycle plan in the commercial space along with commercial support.

DUTIES AND RESPONSIBILITIES: Primary role is a process development scientist supporting activities that support rapid commercialization of transformational cell therapies.

Develop and execute plans ranging from feasibility to implementation for redefined manufacturing processes in the clinical and commercial space with dramatically improved: Cost of goods Process and product quality Manufacturing success rate and robustness Scalability and labor efficiency Cycle time Function as key scientific/engineering SME with a team of experienced process engineers.

Interface with MSAT, product sciences, analytical development and validation teams to generate and analyze process development data and collaborate with process characterization to assess impact to control strategies.

Understand multinational regulatory and GMP requirements, interpret these to direct process development, and prepare materials for filings.

Maintain and spread knowledge of current scientific literature and apply key concepts to project activities and plans.

Provide process-related input to clinical or commercial manufacturing facility design, transfer, and startup.

Interact extensively with Research, Quality, Manufacturing, Regulatory, Pre-Clinical, Clinical, and Commercial Teams and other personnel to support cross-functional project strategy.

Mentor staff to achieve their potential.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities: Education & Experience: BS with 10 years, MS with 8 years or PhD with 1 years of experience in process development for cell therapies, biologics, or related products Proven track record in late stage process development or a related development function in industry or other GMP manufacturing associated environments Ability to lead across sites via electronic media and 20% travel Strong technical qualifications including knowledge and application of engineering fundamentals Knowledge of regulatory standards applicable to cellular and biological products, the developing cellular immunotherapy field, and GMPs Extensive cell culture expertise as well as familiarity with underlying cell therapy immunobiology, metabolism, and common analytical methods Excellent leadership, communication, advocacy, writing, and presentation skills Around the world, we are passionate about making an impact on the lives of patients with serious diseases.

Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.