Process Engineer III

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.

Bristol Myers Squibb is developing novel cellular immunotherapies based on two distinct and complementary platforms – Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies. Our goal is to revolutionize medicine by re-engaging the body’s immune system to treat cancer.

We are looking for a Process Engineer to join the External team within the Cell Therapy GMSAT (Global Manufacturing Science and Technology) department. The successful candidate will collaborate with the GMSAT teams in Seattle and New Jersey locations in the US and support efforts related to the tech transfer of cell therapy manufacturing technologies to external Contract Manufacturing Organizations (CMOs). The Process Engineer will be responsible for the implementation of technologies, including cross-departmental collaboration to enable facility fit, development of process documentation (Batch Records, Forms, etc), e-systems deployment, inspection readiness, and training. This engineer will have responsibilities like an internal MSAT organization for Celgene’s cell therapy drug product manufacturing site with the focus on supplementing the technical capabilities of the CMO. This person may be responsible for and support processes from early clinical phase through PPQ and commercial manufacturing support. The Process Engineer will support product life-cycle management, including commercialization and evolution of cell therapy products as well as day to day operations technical support at CMOs to ensure reliable quality supply. The role will be highly cross-functional and will interact with other CTDO/GPDO groups and in-country affiliates in establishing manufacturing and technology capability, CMO selection, facility fit and design, equipment selection, and facility start up work force training.

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


Drive process and technology transfers, lead project teams, change management, and provide technical process support for routine clinical and/or commercial cell therapy manufacturing at the CMO.

Implement and support the execution of process control strategies including execution of process risk assessments, and continued process verification.

Lead production related investigations, ensuring compliance with internal standards and regulatory requirements

Perform monitoring of manufacturing processes to understand process capability.

Develop, understand, and manage tools and templates that can be used to quantify impact and criticality for parameters and attributes within Celgene and/or CMO unit operations

Lead design activities for clinical and/or commercial facilities

Leverage and maintain strong relationships with external partners

Support product implementations in coordination with Development, Manufacturing, and Quality groups, including visits to contract manufacturing sites

Maintain permanent inspection readiness and actively support regulatory inspections

Ensure manufacturing processes are in a state of control, harmonized across the cell therapy manufacturing network

Develop, execute manufacturing process improvement activities in accordance with the overall life cycle plan for the product

Share operational and process leaning with the rest of the manufacturing network

Provide necessary technical analysis to enable decisions related to new raw materials or selection of CMOs

Ensure technical input is provided in developing the supply and quality agreements


Skills/Knowledge Required:


B.S. with 6 years of relevant experience in Biochemical, Chemical, or Biomedical Engineering or Cell Biology/Immunology discipline

Three years of extensive experience in a regulated GMP manufacturing environment (clinical and/or commercial)

Experience with cellular therapies is strongly preferred

Experience with technology transfer is strongly preferred

Experience with process validation is strongly preferred

Flexibility to travel internationally and work within manufacturing schedules

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

Familiarity with literature on process development and cell therapy

Ability to assess risk and develop contingency plans for process risks

Excellent communication, writing, organizational, teamwork, and presentation skills

Strong interpersonal and leadership skills to work with teams in different functions and organizations


Additional Skills:


Create an environment of teamwork, open communication, and sense of urgency

Drive strong collaboration within the group and across functions

Build trust and effective relationships with peers and stakeholders

Foster a culture focused on science and compliance and strong environmental, health, and safety performance

Have a mindset of continuous improvement, problem solving, and prevention


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.

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