Senior Principal Engineer, MSAT in Summit, NJ

Company: Bristol-Myers Squibb
Location: Summit
Posted on: March 9, 2025

Job Description:

Senior Principal Engineer, MSAT in Summit, NJSenior Principal Engineer, MSAT in Summit, NJWorking with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.This Senior Principal Engineer, MSAT Process Engineering is responsible for supporting the production of personalized cell therapy products for both global clinical trials and commercial supply for multiple products.Areas of responsibility include (a) providing day-to-day manufacturing support, (b) leading manufacturing investigations pertaining to the process control strategy and associated elements, (c) managing multidisciplinary projects aimed at improving the process and/or drug product life cycle sustainability, (d) managing CPV and process monitoring program, and (e) support development and lifecycle management of MBR, MES, and/or eBR.These areas include creation/revision of documentation (i.e. SOP, change control, validation documentation, technical reports, etc.) and management of internal / external team of resources (e.g. engineers and/or scientists) required to support the production of personalized cell therapy products. Cross-functional collaboration with SMEs from the Development Group, Manufacturing Group, Supply Chain Group, and Quality Group is essential to ensuring technical support is delivered to a rapidly growing CAR-T manufacturing organization.Shifts Available:Monday - Friday, Standard Working Hours, OnsiteResponsibilities:

• Support all MS&T activities to ensure uninterrupted clinical/commercial supply.
• Knowledge of cGMPs and multi-national biopharmaceutical regulations. Cell therapy experience is a major plus.
• Ensure Safe and Compliant cGMP operations through 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.
• Knowledge of the relationship between manufacturing processes, ERP, and MES a major plus.
• Must have excellent organization skills and ability to handle multiple tasks.
• Hands-on experience with single-use technologies, closed systems, and cold chain/cryogenic technologies.
• Lead team of engineering and/or scientists for front-line support of the manufacturing process for cell therapies.
• Support product quality evaluations and investigations ensuring compliance with internal standards and regulatory requirements.
• Possess strong verbal/written communication skills.
• Ability to think strategically and to translate strategy into actions.
• Support Continued Process Validation (CPV) and lead team in support of Statistical Process Control monitoring program and Statistical Alert Event evaluations/investigations.
• Develop, understand, and manage tools/templates to monitor manufacturing process performance and enable understanding of process capability.
• Collaborate within the plant and across the Network.
• Promote mindset of continuous improvement, problem solving, and prevention.Knowledge and Skills:
  • Exhibit exceptional team leadership skills.
  • Demonstrated experience and implementation success with various Agile methodologies.
  • Excellent oral and written communication and presentation skills. Ability to influence at all levels.
  • Advanced critical reasoning and decision-making skills.
  • Ability to think strategically and translate strategy into actions.
  • Ability to work independently and in cross-functional teams.
  • Advanced technical document writing.
  • Advanced time management skills, including prioritizing and managing expectations in a fast-paced working environment.
  • Must have excellent organization skills and ability to manage multiple tasks.
  • Operate effectively and with moderate supervision within a team or independently, performing projects and related duties.
  • Intermediate knowledge of MS Office Applications.
  • Working knowledge of Electronic Batch Records (EBR), Review by Exception (RBE), and MES Recipe object lifecycle management preferred.
  • Experience with HP ALM, Electronic Document Management Systems, and Change Management Systems preferred.
  • Knowledge of cGMPs and multi-national biopharmaceutical regulations. Cell therapy experience is preferred.
  • Knowledge of the relationship between manufacturing processes, ERP, and MES preferred.
  • Experience with single-use technologies, closed systems, and cold chain/cryogenic technologies is preferred.
  • Proficiency utilizing MS Office products and working knowledge of statistical software (R, JMP, Minitab) required.
  • Possess strong verbal and written communication skills.
  • Ability to communicate honestly, transparently, and effectively with peers, department management, and cross-functionally.
  • Hands-on experience preferred with CAR T or biopharmaceutical manufacturing and Quality Control.
  • Proven delivery of complex investigation reports preferred.
  • Ability to coach, develop, delegate, and motivate others.Basic Requirements:
    • Biochemical, Chemical, Biomedical Engineering or Cell Biology/Immunology discipline with
      • B.S. with 8-10 years of relevant experience
      • M.S with 7-10 years of relevant experience
      • Ph.D. with 5-7 years of relevant experience
      • Experience level will determine position title and enterprise grade level.
      • Four 4+ years of leadership, technical transfer, strategy lead, and management experience.
      • Understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique, packaging, shop floor quality, batch review, or disposition preferred.
      • Experience with MES, ERP, LIMS, or other manufacturing boundary systems.
      • Flexibility to work within manufacturing schedules.
      • Ability to work in a self-driven, performance/results oriented, fast paced matrix environment Excellent communication, writing, sense of urgency, teamwork, and presentation skills.
      • Strong interpersonal skills required to work with teams in different functions and organizations.
      • Demonstrated ability to effectively work in cross functional teams, meet deadlines, and prioritize multiple projects.
      • Detail oriented with excellent verbal and written communication skills.Working Conditions:
        • This position requires up to 20% of travel (as required).
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Keywords: Bristol-Myers Squibb, New York , Senior Principal Engineer, MSAT in Summit, NJ, Engineering , Summit, New York