Principal Bioengineer, Cell Therapy Development (R1556515-en-us)
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.Position
Principal Bioengineer Cell Therapy DevelopmentDepartment
Drug Product Process DevelopmentPrerequisites
B.S., M.S., or Ph.D. in Biochemical, Chemical, or Biomedical Engineering or related scientific/engineering discipline with relevant experience
This individual will be a high level lead of technical and strategic aspects of cell therapy process development specializing in improving product/process characteristics, process characterization, and manufacturing support/troubleshooting activities. He/she will be a cross-functional strategic and scientific lead, a multi-functional team coordinator, and a mentor to experienced engineers. Strong application of previous experience and engineering fundamentals to equipment and process design is a must. He/she will be responsible for achieving a commercially viable, scalable, GMP-compatible process, while maintaining product quality.
Responsibilities will include, but are not limited to, the following:
- With collaborating global functions, lead the definition and updates of processes via detailed engineering analyses, pragmatic approaches, and experimentation using relevant models and analytics
- Demonstrate, refine, and adapt process to GMP needs at clinical scale
- Demonstrate feasibility of commercial-scale production
- Lead the generation of technical reports and presentations to communicate key project progress
- 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 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
- Lead the transfer of new products along with the clinical startup
- Supervise, develop, mentor, and delegate activities to staff including collaborators
- Develop a team-oriented environment to achieve common project goals
- Interact extensively with Research, Process Development, Quality, Manufacturing, Regulatory, Pre-Clinical, 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 9 - 12 years, M.S. with 6-9 years, or Ph.D. with 4-6 years relevant experience in Biochemical, Chemical, or Biomedical Engineering or related engineering 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 engineers
- Excellent communication, writing, organizational, and presentation skills
- Experience working in a regulated environment and preparing 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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
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