Process Engineer II 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.

Job Purpose / Position Summary

We are looking for a Process Engineer to join the drug product team within the Cell Therapy GMSAT (Global Manufacturing Science and Technology) department. Global Manufacturing Sciences and Technology is responsible for tech transfer, support and harmonization of Cell Therapy Manufacturing Processes across the manufacturing network throughout the product life-cycle from pre-clinical through commercial manufacturing. The Process Engineer II will be responsible for the implementation of cell therapy manufacturing technologies, including cross-departmental collaboration to enable facility fit, development of process documentation (Batch Records, Forms, etc), e-systems deployment, inspection readiness, and training. The Process Engineer II will support product lifecycle management, including commercialization and evolution of cell therapy products as well as day to day operations to ensure reliable quality supply. The role collaborates across all CMC functional areas to ensure project advancement, rapid and best in class execution, and communication of challenges/opportunities.

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


Support process and technology transfers, change management, and technical process support for cell therapy products.

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

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

Perform monitoring of manufacturing processes to understand process capability.

Provide necessary technical analysis to support impact assessments and investigations.

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

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


Basic Qualifications:


MSc or BSc in Chemical Engineering, Biochemical Engineering or equivalent with minimum of 3 years of relevant experience. Familiarity with cell therapy processes and cGMPs is preferred.

Ability to effectively work in cross functional teams, meet deadlines, and prioritize responsibilities.

Experience working in a self-driven, performance/results oriented, fast paced matrix environment.

Excellent problem-solving skills, including issue resolution, root cause investigations and CAPAs.

Ability to assess risk and develop contingency plans for process risks

Able to manage time and elevate relevant issues to project lead and line management.

Detail oriented with excellent verbal and written communication skills.

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


Preferred Qualifications:


Experience with cell therapy process development and / or manufacturing

Experience with technology transfer in a manufacturing environment

Proficiency utilizing MS Office products and working knowledge of statistical software (R, JMP, Minitab)

2-3 years of experience in cell therapy process development and/or manufacturing.

Experience with commercial product support, i.e. post-marketing commitments, on-going validation and comparability


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

Sign Up Now - MiamiCrossing.com