Senior Specialist, MSAT Cell Therapy Engineering Services, Aseptic Processing & Environmental Controls

Bristol Myers Squibb • Bothell, WA

10d • Hybrid

About The Position

Senior Specialist, MSAT Cell Therapy Engineering Services, Aseptic Processing & Environmental Controls is responsible for supporting the production of personalized cell therapy products for clinical and commercial supply at the BMS Manufacturing Plant (Jump), in Bothell, WA. This role provides support to ensure the compliance of aseptic processes and environmental control systems. This role supports airflow visualization study (AVS), aseptic process simulation (APS), cleanroom reclassification (CRC), environmental monitoring performance qualification (EMPQ), and non-routine simulation (NRS) programs as a member of the Bothell Manufacturing Sciences and Technology (MSAT) department.

Requirements

• Bachelor's Degree in life sciences/engineering/STEM or equivalent
• 3+ years relevant experience in biologics or cell therapy manufacturing or development with BS, or 2+ years relevant experience with MS
• Knowledge of cGMP, GDP, GXP, including 21CFR part 11, EU GMP Annex and multi-national regulations, related to aseptic processes and environmental control systems preferred
• Knowledge of microbiology, aseptic processing, and facility qualification preferred
• Excellent project and program management, communication skills, and technical writing skills are required.

Responsibilities

• Support the AEC team in planning, development, execution, and authoring of reports on APS, AVS, CRC, EMPQ, and NRS aseptic and environmental control activities
• Assist in coordinating with cross-functional teams comprised of Materials Management, Manufacturing, Patient Services, Scheduling, Quality Assurance, Quality Control, and Validation
• Investigate and resolve deviations and non-conformances with oversight from Validation and Quality Assurance leadership
• Support developing the requalification schedule for routine APS and CRC
• Develop and manage electronic validation documentation such as risk assessments, protocols, studies, and reports using the ValGenesis validation lifecycle information management system and Infinity
• Serve as a subject matter expert (SME) for aseptic and environmental control programs with strong technical knowledge of cellular therapy systems, materials, equipment, and aseptic processing techniques
• Support quality record processing by owning impact assessments, quality actions, and supporting production related investigations to maintain the validated state of the aseptic process
• Ensures compliance with all regulatory requirements and industry standards related to aseptic and environmental control
• Assists on one or more projects within the AEC area.

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.
• Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level