Principal Engineer Cell Therapy

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.

Summary:

The Principal Engineer, Cell Therapy will lead a multi-project lifecycle development of a late-stage CAR T cell therapy product. He/She will be accountable for developing process development changes to improve manufacturing success rate, reducing costs of goods and services, qualify secondary vendors of raw materials, improve manufacturing turnaround time and support the regulatory filings.

This Principal Engineer will lead a multi-functional team of approximately 5 – 6 Engineers as a strategic and scientific supervisor and mentor. He/She will foster a collaborative work environment and guide team members to ensure sound technical decision making.

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

Advance commercial process changes aimed at improving manufacturing success rate, reducing costs, and improving manufacturing turnaround time

With collaborating global functions, lead the definition and updates of processes via detailed engineering analyses, pragmatic approaches, and experimentation using relevant models and analytics

Work closely with manufacturing technology development teams to develop target changes

Collaborate on comparability strategy for process changes in the late-stage clinical/commercial setting

Lead the generation of technical reports and presentations to communicate key project progress

Prepare regulatory submissions for changes

Collaborate with operational teams for seamless implementation of changes in the GMP setting

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

Provide process-related input to facilities designed for pivotal clinical or commercial supply

Serve as a subject matter expert in process development for autologous T cell therapies

Provide strategic direction to multi-functional teams

Supervise, develop, mentor, and delegate activities to staff including collaborators

Maintain a team-oriented environment to achieve common project goals

Interact extensively with Process Development, MS&T, Manufacturing, Quality, Regulatory and Clinical and other personnel as dictated by project need. Contribute in a team-oriented environment to achieve common project goals.

Leverage and maintain strong relationships with external partners

Skills/Knowledge Required:

B.S. with 10 - 12 years, M.S. with 8-10 years, or Ph.D. with 1-4 years relevant Process Development experience in Biochemical, Chemical, or Biomedical Engineering or Biology related discipline

Experience leading both direct reports and cross-functional teams

Cell Therapy or Biologics Experience is highly preferred.

Strong grasp and application of engineering fundamentals

Established track record of success with sound technical qualifications and knowledge in process development

Familiarity with literature on process development and cell therapy

Ability to assess risk and develop contingency plans for process risks

Excellent communication, writing, organizational, and presentation skills

Experience working in a regulated environment and preparing global regulatory documents

Interpersonal and leadership skills to work with teams in different functions and organizations

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