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 6518 years of experience; OR
• Bachelor's Degree in a non-technical discipline with 6511 years of experience; OR
• Bachelor's Degree in a Scientific or relevant Technical area with 6517 years of experience; OR
• Master's Degree in a Scientific or relevant Technical area with 6515 years of relevant experience; OR
• PhD in a Scientific or relevant Technical area with 6513 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

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully - carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits:

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans - including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.

Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.

Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.

U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

How We Work

Where you work matters - because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.