Scientist – Quality Control Laboratory

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. Key responsibilities • Designated Subject Matter Expert of test methods/processes. • Supports or leads method transfer and validation of in-process, final product, and stability methods. • Perform review of testing data (e.g., data packets, final lot file, COA review). • Anticipate and perform complex troubleshooting and problem solving independently. • Perform release/stability testing for complex and non-complex methods on intermediate or finished product as required. • Perform data verification, data review and review of GMP documentation for multiple methods (general and complex) and/or products. • Analyzes performance metrics and trending data. • Own project, CAPA and deviation/investigation related tasks and/or continuous improvement efforts. • May represent the department in regulatory inspections (internal and external audits). • Train and mentor others on multiple QC test methods, processes and procedures. • Cross trained on multiple complex analytical methods and/or multiple products. • Author and review/revise technical documents such as test methods, SOPs, specifications, trend reports and/or sample plans as appropriate. • Contributes to and may lead complex projects inside and outside of team. • Owns and/or contributes to change controls. • Identifies and escalates challenges and barriers to execution, suggests solutions, and leads remediation. • Positive, supportive, and actively collaborates both within and outside the team. • Actively and positively participates or leads in Operational Excellence (OpEx) and Continuous Improvement (CI) initiatives in the team. • Complete all required tasks compliantly and safely while consistently and intentionally modeling BMS values (Integrity, Accountability, Passion, Urgency, Innovation, and Inclusion). • Local management may assign additional activities as part of the job duties. • Support analytical/microbiological method validations, equipment qualifications, and Aseptic Process programs. • Perform other tasks as assigned. Role-Specific Assignments – Aseptic Process & Environmental Monitoring Oversee and support all elements related to Aseptic Process (AP), the site Media Fill (MF) Program and the annual MF requalification's. • Oversee and support all elements related to the site Air Visualization Studies (Smoke Studies). • Develop Environmental Monitoring (EM) qualifications, EM requalification's, and EM Trend Reports. • Oversee and support the site Environmental Review Committee. • Develop/assess that the site aseptic techniques practices, cleaning and sanitization practices, and the validation of clean rooms/isolators, are adequate and in alignment with regulatory expectations/standards. • Participates in the critical review of all documents associated with the manufacturing aseptic processing. • Support APQR elements from an Aseptic Process perspective. • Provides formal presentations to upper management on environmental monitoring trends and aseptic processing status and opportunities, as applicable. • Supports complex Microbiology laboratory investigations, ensuring identification of the root cause and the corrective and preventive action to prevent re-occurrence. • Support Regulatory Filings related to Aseptic Process (Media Fill/AVS/EM). • Supports internal inspections/GEMBA walks to ensure manufacturing/supporting areas are complying and vigilant of