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

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Challenging. Meaningful. Life-changing. Those arent 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. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside high-achieving teams. Take your career farther than you thought possible.

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• 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.

Responsibilities include but are not limited to the following:

• 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.

Qualifications

• Bachelors 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.

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If you come across a role that intrigues you but doesnt perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job such as required skills where the job is performed the employees work schedule job-related knowledge and experience. Final individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits please visit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• 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.

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With a single vision as inspiring as Transforming patients lives through science every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture promoting global participation in clinical trials while our shared values of passion innovation urgency accountability inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

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Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles onsite presence is considered an essential job function and is critical to collaboration innovation productivity and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application or in any part of the recruitment process direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.

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BMS will consider for employment qualified applicants with arrest and conviction records pursuant to applicable laws in your area.

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