Sr. Specialist, Aseptic Observation Program

Bristol Myers Squibb

Bothell, WA

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JOB DETAILS

SALARY

$96,832–$117,338 Per Year

SKILLS

Asepsis, Best Practices, Biochemistry, Biology, Biotech and Pharmaceutical, Cell Biology, Change Management, Cleanroom, Clinical Trial, Coaching, Code of Federal Regulations, Collective Bargaining, Communication Skills, Consulting, Continuous Improvement, Corrective Action, Cross-Functional, Current Good Manufacturing Practice (cGMP), Disability Accommodations, Documentation, Ergonomics, External Audit, Field Sales, GMP (Good Manufacturing Practices), GxP, ISO (International Organization for Standardization), Internal Audit, Leadership, Maintain Compliance, Manufacturing, Manufacturing Operations, Microbiology, Operational Improvement, Operational Support, Process Improvement, Quality Assurance, Quality Management, Record Keeping, Regulations, Regulatory Compliance, Regulatory Requirements, Root Cause Analysis, Sales Operations, Standard Operating Procedures (SOP), Team Player, Training Program, Willing to Travel

LOCATION

Bothell, WA

POSTED

7 days ago

**Working with Us** Challenging. Meaningful. Life-changing. Those aren't 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. You'll 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. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Aseptic Observation Program (AOP) Sr. Specialist is responsible for training, observing, and evaluating aseptic practices within the manufacturing environment to ensure compliance with regulatory requirements and internal procedures. This role supports the maintenance of a contamination-free environment by observing, documenting, and providing feedback on aseptic techniques, behaviors, and processes. The specialist serves as the manufacturing subject matter expert in aseptic behaviors and practices, collaborating with cross-functional teams for investigations, drive continuous improvement in aseptic operations, and supporting training initiatives. **Duties/Responsibilities** · Observe aseptic operations (e.g., filling, media preparation, gowning) to ensure adherence to Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), and regulatory requirements. · Document observations in real-time and areas for improvement. · Provide immediate feedback and coaching to operators and managers regarding aseptic technique, gowning, and compliance. · Perform staff Aseptic Processing and Gowning Qualifications. · Participate in root cause analysis and investigations related to aseptic process deviations or contamination events. · Performs document revisions as needed to improve instructions and training. · Support the development and delivery of aseptic technique training programs. · Collaborate with Quality Assurance, Manufacturing, and MSAT teams to implement corrective and preventive actions. · Maintain detailed records and reports of observations, findings, and recommendations. · Stay current with industry best practices, regulatory updates, and training related to aseptic processing. · Assist in internal and external audits as a subject matter expert for aseptic operations. · May support APS, CRC, and EMPQ activities through aseptic observations. **Reporting Relationship** Manager/Sr. Manager **Qualifications** **Education/Experience:** Bachelor's Degree in cell biology, biotechnology, biochemistry, microbiology, life sciences, or equivalent with a minimum of 4 years of relevant experience in biologic or cell therapy. Knowledge of regulatory requirements, including current Good Manufacturing Practices (cGMP), Good Practices (GxP), 21 CFR Part 11, Good Documentation Practices (GDP), and Annex 1. · Excellent observational, documentation, and communication skills. · Ability to work independently and collaboratively in a fast-paced environment. · Experience with training or coaching operators is a plus. Experience with ergonomics relating to aseptic techniques and aseptic behaviors. Experience with electronic quality management systems. Experience with cleaning and sanitization practices. **Skills & Abilities:** · Certification in aseptic processing or quality assurance. · Experience with sterile injectable products. · Experience with electronic quality systems. · Knowledge of cGMPs. Cell therapy and aseptic processing experience is required. · Ability to collaborate and influence cross-functional teams. · Experience with leading change management is preferred. **WORKING CONDITIONS (US Only):** · Must be able to work in a cleanroom environment that requires gowning within ISO 5/7 (Grade A/B). · Must be able to stand for extended periods of time. · Work in areas that may have strong magnets. · Work in areas where handling human blood products (Biosafety Level 2) may be required. · May work in areas with exposure to vapor phase liquid nitrogen. · Must be able to gown in and be present in the Grade A/B environment for extended periods of time. **Shifts:** Sun - Wed: 7am - 5:30pm Sun - Wed: Noon - 10:30pm Wed - Sat: 7am - 5:30pm Wed - Sat: Noon - 10:30pm If you come across a role that intrigues you but doesn't 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. **Compensation Overview:** Bothell - WA - US: $96,832 - $117,338 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 employee's 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 https://careers.bms.com/life-at-bms/. Benefit 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:** T he 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. **Uniquely Interesting Work, Life-changing Careers** 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** BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: 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. **Supporting People with Disabilities** 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 adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement. **Candidate Rights** BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ **Data Protection** We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection . Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com . Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley. R1602143 : Sr. Specialist, Aseptic Observation Program **Company:** Bristol-Myers Squibb **Req Number:** R1602143 **Updated:** 2026-05-14 02:30:10.747 UTC **Location:** Bothell-WA Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

About the Company

Bristol Myers Squibb

INDUSTRY

Other/Not Classified

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