Scientist – Quality Control Laboratory

Bristol Myers Squibb • Manatí, PR

15h • $76,650 - $92,885 • Onsite

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.

Requirements

• 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.

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.
• 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.

Benefits

• wellbeing support
• retirement and financial protection benefits
• insurance offerings (medical, dental, vision, life and disability)
• Flexible Time Off (FTO)
• 11 paid company holidays
• 160 hours of paid vacation annually for new hires
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior