Senior Specialist - MSAT Cell Therapy Engineering Support, Process Support

Bristol-Myers Squibb • Bothell, WA

3d

About The Position

The primary focus of the Senior Specialist - MSAT Cell Therapy Engineering Services, Process Support is to provide product and process support to Cell Therapy Manufacturing Operations at Bristol Myers Squibb's GMP facility in Bothell, WA. The Senior Specialist - MSAT Cell Therapy Engineering Services, Process Support: Is a process and product expert Authors product impact assessments to determine impact to product from deviating events Works with applicable SMEs to determine immediate corrections for manufacturing events Supports product impacting root cause investigations and identification of corrective actions Owns and drives GMP Quality System records to deliver MSAT initiatives Leads/supports process improvement and lean initiatives to support productivity gains Makes data driven decisions and recommendations Leads MSAT driven cross-functional and cross-site projects Routinely collaborates with global teams and other CTDO sites

Requirements

• Demonstrated problem-solving skills, including issue resolution, root cause investigations
• Demonstrated ability to effectively work in and lead cross functional teams, meet deadlines, and prioritize multiple projects
• Able to apply engineering principles and statistical analysis to resolve processing issues and evaluate process improvement opportunities
• Demonstrated scientific and technical acumen including technical writing skills
• BS and/or MS degree in Science or Chem/Bio Engineering
• 3+ years relevant experience in biologics or cell therapy manufacturing or development with BS, or 2+ years relevant experience with MS

Nice To Haves

• Immunology education preferred
• cGMP, Lean/six sigma

Responsibilities

• Functions as a technology, product, and process subject matter expert; may serve as system SME on one or more manufacturing unit operations or families of equipment
• Provides on-the-floor and on-site/remote troubleshooting and technical support (including on-call coverage outside of business hours)
• Facilitates deviation prevention and deviation closure through site quality systems
• Analyzes and summarizes manufacturing data to support impact assessments and investigations
• Supports site risk assessment program and owns MSAT related risk assessment documentation, as applicable
• Analyzes trends of clinical and commercial production data to drive actions for manufacturing process improvement
• Uses continuous improvement/lean tools to identify opportunities for process improvements and operational efficiencies, and drives cross-functional projects to implement
• Represents MSAT when interfacing with other local and global functional teams

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees