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.
This individual will lead a multi- project lifecycle development of a late-stage CAR T cell therapy. Accountable for developing process 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. Will be a multi-functional team strategic and scientific coordinator and a mentor to less experienced engineers. Foster 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
B.S. with 10 - 12 years, M.S. with 8-10 years, or Ph.D. with 1-4 years relevant experience in Biochemical, Chemical, or Biomedical Engineering or Biology related discipline
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
Experience leading both direct reports and cross-functional teams
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
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.