Sr. Specialist, Aseptic Observation Program

Bristol Myers Squibb EU Policy; Bothell (WA); On-site; USD 97,000 - 117,000; Full time

Benefits offered by this job

Flexible Time Off

11 paid company holidays

Global shutdown period

Job summary

Bristol Myers Squibb in Bothell, WA, seeks an Aseptic Observation Program Sr. Specialist to train, observe, and evaluate aseptic practices to ensure GMP compliance and a contamination-free environment.

You will document observations, provide feedback, perform gowning qualifications, support investigations, and collaborate with QA, Manufacturing, and MSAT to drive CAPAs. A Bachelor's in life sciences with 4+ years in biologics/cell therapy is required.

Qualifications

• Bachelor’s degree in cell biology, biotechnology, biochemistry, microbiology, life sciences, or equivalent.
• 4+ years of relevant biologics or cell therapy experience.
• Knowledge of cGMP, 21 CFR Part 11, GDP, and Annex 1.
• Excellent observational, documentation, and communication skills.
• Experience with training or coaching operators.
• Experience with electronic quality management systems.
• Experience with sterile injectable products.
• Ability to collaborate across QA, Manufacturing, and MSAT.

Responsibilities

• Observe aseptic operations to ensure GMP and SOP compliance.
• Document observations and identify areas for improvement.
• Provide immediate feedback and coaching on aseptic technique.
• Perform staff Aseptic Processing and Gowning Qualifications.
• Support investigations of aseptic deviations and CAPAs.
• Maintain detailed records and prepare reports.
• Stay current with industry best practices and regulatory updates.

Skills

Observational skills

Documentation

Communication

Training coaching

Gowning qualifications

Cross-functional collaboration

Change management

Ergonomics in aseptic techniques

Electronic quality systems

cGMP knowledge

Cell therapy knowledge

Education

Bachelor’s degree in life sciences

Job description

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

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

Compensation Overview

Bothell - WA - US: $96,832 - $117,338

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.

Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.

Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.

U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

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 [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

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

For roles based in Los Angeles County only: 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/

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