Position Summary

Subject matter expert supporting method transfer/validation and routine testing of in-process, final product, and stability samples. Perform data review/verification, complex troubleshooting, and method training. Own project, document revisions, deviations/investigations/CAPA, and continuous improvement efforts

Key Responsibilities
• Subject matter expert supporting method transfer/verification/ validation and routine testing of in-process, final product, and stability samples.
• Perform review of testing data (e.g., data packets, final lot file, COA review).
• Anticipate and perform complex troubleshooting and problem solving independently.
• Perform data verification, data review and review of GMP documentation for multiple methods (general and complex) and/or products.
• 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 microbiology 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.
• Perform other tasks as assigned.

Qualifications & Experience
• Bachelor's degree or equivalent required, preferably in science. Advanced degree preferred.
• 6+ years of relevant microbiological testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment.
• Demonstrated experience with microbiological techniques.
• Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.
• Demonstrated technical writing skills.
• High problem-solving ability/mentality, technically adept and logical.
• Ability to communicate effectively with peers, department management and cross-functional peers about task status, roadblocks and needs.
• Advanced ability to work in a fast-paced team environment, meet deadlines, and prioritize work from multiple projects.
• Advanced knowledge of LIMS, ELN and laboratory data analysis systems preferred.
• Strong mentoring, coaching, influencing, negotiating and personnel interaction skills.

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Compensation Overview:

Devens - MA - US: $99,380 - $120,428

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.