Bristol-Myers Squibb - Bothell, WA

posted 24 days ago

Full-time - Mid Level
Hybrid - Bothell, WA
Chemical Manufacturing

About the position

The Engineer/Senior Engineer position within the Product Management Team at Bristol Myers Squibb focuses on product lifecycle strategy and execution in the Cell Therapy Product Team. The role involves identifying lifecycle initiatives to enhance process robustness, reduce out-of-specification (OOS) investigations, and implement lifecycle management changes across the CTDO network. This position is integral in interfacing with various teams to translate product strategies into effective manufacturing processes, ensuring alignment with regulatory and technical requirements.

Responsibilities

  • Develop deep thorough knowledge of the cell therapy process
  • Evaluate and identify initiatives that support process improvements, robustness, COGM and automation
  • Support tech transfer and OOS investigations
  • Oversee implementation of process initiatives and transfers between sites
  • Partner with product technical stewards and Regulatory teams to align on LCM strategy and manage implementation
  • Ensure technical and manufacturing requirements are addressed throughout lifecycle of new solutions
  • Review technical reports and source documentation to support product lifecycle and regulatory submissions
  • Partner with system integration teams, business process owners and other global teams to align process data handling initiatives within the Process initiatives

Requirements

  • Degree in Biochemical or Chemical Engineering or Sciences: Minimum of a Bachelor's degree with 6-8+ years of experience, Master's degree with 5+ years or Ph.D. degree with 1-2 years of experience
  • Ability to effectively work in cross functional teams, meet deadlines as an individual contributor, and prioritize responsibilities
  • Experience working in a self-driven, performance/results oriented, fast paced matrix environment
  • Experience assimilating large data sets in support of batch history sections for regulatory submissions
  • 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

Nice-to-haves

  • Experience in the biopharmaceutical industry
  • Familiarity with regulatory submissions and compliance
  • Knowledge of cell therapy processes and technologies

Benefits

  • Medical, pharmacy, dental and vision care
  • Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP)
  • Financial well-being resources and a 401(K)
  • Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support
  • Work-life programs including paid national holidays and optional holidays, Global Shutdown days, up to 120 hours of paid vacation, up to two paid days to volunteer, sick time off, and summer hours flexibility
  • Parental, caregiver, bereavement, and military leave
  • Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources
  • Tuition reimbursement and a recognition program
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