Manufacturing Associate II

Bristol Myers SquibbBothell, WA
Onsite

About The Position

Our Associates perform a crucial role in driving our novel cell therapy programs by supporting routine manufacturing operations. We are searching for innovative, intellectually curious individuals with a general understanding of Good Manufacturing Practices (GMPs) to support routine manufacturing operations for Cell Therapy. Successful candidates must be goal-oriented and flexible, with the ability to work effectively and efficiently on a team while demonstrating safety, quality, and GMP compliance at all times.

Requirements

  • 1+ years of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience and education
  • Proven experience working on teams where combined contribution, collaboration, and results were expected
  • Proficiency in common computer tools such as word processing, spreadsheet and web-based applications
  • Meticulous attention to detail and personal accountability are critical to success
  • Demonstrated good interpersonal skills, is attentive and approachable
  • Maintain a professional and productive relationship with area management and co-workers
  • Basic understanding of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is Preferred

Nice To Haves

  • Experience in cell therapy manufacturing, including Cell washing, Cell Expansion processes and automated equipment.
  • Cell separation techniques and automated equipment.
  • Cryopreservation processes and equipment.

Responsibilities

  • Learn and execute Cell Therapy Manufacturing operations compliantly
  • Execute operations as outlined in Source Governing Documents (including but not limited to: Standard Operating Procedures, Work Instructions, Batch Records, Forms)
  • Demonstrate strong practical and theoretical knowledge
  • Executes transactions and process in all electronic systems and adheres to business continuity processes
  • Prioritizes safety of self and others
  • Reports safety events within 24 hours
  • Immediately escalates any/all issues that may impact compliance or safety of self and/or others.
  • Complete documentation required by Source Governing Documents contemporaneously
  • Perform all tasks in a manner consistent with the safety policies, SOPs, quality systems, and GMP requirements including ALCOA+
  • Complete training assignments prior to assigned due date to ensure the necessary technical skills and knowledge
  • Trains for proficiency in process systems and some supporting business systems, and maintains trainer qualifications
  • Collaborate with support groups on recommendations and solving technical and operational problems
  • Train others on Source Governing Documents to successfully complete manufacturing operations
  • Execute daily unit operations schedule, that includes people, product, and material flow across multiple shifts
  • Work within a controlled cleanroom environment and execute aseptic processing procedures (as assigned).
  • Maintain manufacturing environmental conditions (Non-Viable Particulate(s) and Viable microbial levels per controlled area classification specifications) by performing area disinfection regiment as required to meet global Health Authority requirements
  • Continues to refine and improve manufacturing process technique to improve individual operational times.
  • Verifies training completion prior to performing any GxP tasks

Benefits

  • Health Coverage: Medical, pharmacy, dental, and vision care.
  • Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
  • Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
  • Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
  • Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
  • Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
  • All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
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