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
We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.
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 athttps://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
