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 best aseptic process practices.
- ✓Generate protocols, reports, technical documents, EM Trends/start-ups, technical presentations, AP trainings,and Risk Assessments.
Qualifications & Experience
Education & Experience
- ✓Associate’s Degree in a technical, scientific discipline with ≥18 years of experience; OR
- ✓Bachelor’s Degree in a non-technical discipline with ≥11 years of experience; OR
- ✓Bachelor’s Degree in a Scientific or relevant Technical area with ≥7 years of experience; OR
- ✓Master’s Degree in a Scientific or relevant Technical area with ≥5 years of relevant experience; OR
- ✓PhD in a Scientific or relevant Technical area with ≥3 years of relevant experience.
- ✓An equivalent combination of education and experience, preferably in a regulated environment, will be considered.
#BMSBL
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.
Compensation Overview
Manati - PR - US: $76,650 - $92,885