Sr. Specialist, Aseptic Observation Program

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.

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