Sr. Specialist, Aseptic Observation Program
Bristol Myers Squibb
Remote
$107,085 Salary, Full-Time
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Job Description
- Working with Us
- Challenging.
Read more:
careers.bms.com/working-with-us .- Position Summary
- The Aseptic Observation Program (AOP) Sr.
- 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.
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.
Eligibility Disclosure:
- T he summer hours program is for United States (U.
- 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.
- On-site Protocol
- BMS has an occupancy structure that determines where an employee is required to conduct their work.
- 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.
- 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.
R1602143
: Sr. Specialist, Aseptic Observation ProgramCompany:
- Bristol-Myers Squibb
Req Number:
R1602143
Updated:
- 2026-05-14 02:30:10.747 UTC
Location:
- Bothell-WABristol Myers Squibb is an equal opportunity employer.
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