Sr. Specialist, Aseptic Observation Program
About The Position
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.
Requirements
- 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.
- Cell therapy and aseptic processing experience is required.
- Ability to collaborate and influence cross-functional teams.
Nice To Haves
- 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.
- Certification in aseptic processing or quality assurance.
- Experience with sterile injectable products.
- Experience with electronic quality systems.
- Knowledge of cGMPs.
- Experience with leading change management is preferred.
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.
Benefits
- wellbeing support
- retirement and financial protection benefits
- insurance offerings (medical, dental, vision, life and disability)
- Flexible Time Off (FTO)
- 11 paid company holidays each year
- 160 hours of paid vacation annually
- 3 optional holidays
- paid sick leave
- up to two paid volunteer days per year
- summer hours flexibility
- leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
- annual Global Shutdown between Christmas Day and New Year's Day
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What This Job Offers
Job Type
Full-time
Career Level
Senior
