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Sr. Principal/Associate Director – Process Engineer
| Company | Bristol Myers Squibb |
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| Location | Summit, NJ, USA |
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| Salary | $156000 – $195000 |
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| Type | Full-Time |
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| Degrees | Bachelor’s, Master’s |
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| Experience Level | Senior, Expert or higher |
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Requirements
- MSc, or BSc in Chemical Engineering, Biochemical Engineering or equivalent with minimum of 12+ years of relevant experience.
- Ability to effectively lead cross functional teams, meet deadlines, and prioritize responsibilities.
- Advanced data management and statistical analysis skillset
- 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.
Responsibilities
- Lead process and technology transfers, change management, and technical process support for commercial cell therapy products.
- Owner of process control strategies including process risk assessments and continued process verification.
- Comprehensive data analyses using historical process experience and characterization studies to identify trends in process performance and drive changes in the process control strategy and risk assessments.
- Lead production related investigations, ensuring compliance with internal standards and regulatory requirements.
- Own Stage III validation (CPV) reports including process monitoring of manufacturing processes to understand process capability and performance drift over time.
- 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.
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, Spotfire, Minitab)
- 10-12 years of experience in cell therapy process development, MS&T, and/or manufacturing
- Experience with commercial product support, i.e. post-marketing commitments, on-going validation and comparability
