Senior/Principal Engineer, CTTO Vector MS&T

7 days ago

Summit, New Jersey, United States Bristol-Myers Squibb Full time
About the Role

Bristol-Myers Squibb is seeking a highly skilled Senior/Principal Engineer to join our Cell Therapy Technical Operations (CTTO) division. As a key member of our Viral Vector Commercial Network Manufacturing Science and Technology (MS&T) group, you will play a critical role in providing commercial manufacturing support for our CMO GMP manufacturing facilities.

Key Responsibilities
  • Commercial Manufacturing Support: Provide technical process support for routine clinical/commercial batches and assist QA with on-time closure of all quality system records such as deviations, CAPAs, and change controls.
  • Process Development and Implementation: Develop and manage tools/templates to monitor vector manufacturing process performance and enable understanding of process capability. Implement and support the execution of process control strategies, including execution of process risk assessments and CPV.
  • Regulatory Compliance: Ensure the manufacturing process is in a state of control through an understanding of CPV data. Support production-related investigations, determining the root cause and ensuring compliance with internal standards and regulatory requirements.
  • Technical Reporting and Documentation: Write technical reports in support of manufacturing process changes, deviation investigations, and regulatory filings.
  • Process Improvement and Knowledge Sharing: Develop and execute manufacturing process improvement activities in accordance with the overall life cycle plan for the product. Share operational best practices and process learning with the rest of the manufacturing network.
Requirements
  • Education and Experience: Bachelor's degree in Biochemical, Chemical, Biomedical Engineering, or Cell Biology/Immunology with a minimum of 6 years of relevant experience, or Master's degree with a minimum of 4 years of relevant experience, or Ph.D. with a minimum of 2 years of relevant experience.
  • Technical Expertise: Strong knowledge and engineering leadership for viral vector manufacturing and processing equipment, manufacturing support, and technology transfer. Experience with cellular therapies is preferred.
  • Communication and Collaboration: Demonstrated strong written and verbal communication, interpersonal skills, presentation skills, time management skills, sense of urgency, attention to detail, teamwork, and cross-functional collaboration.
  • Technical Skills: Proficiency utilizing MS Office products and working knowledge of statistical software (R, JMP, Minitab) strongly preferred.
About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company dedicated to transforming patients' lives through science. Our mission is to discover, develop, and deliver innovative medicines that help patients overcome life-threatening diseases. We are committed to creating a diverse and inclusive workplace where our employees can thrive and contribute to our mission.

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