Position Summary

Stability Scientist is responsible for providing stability program operational support for stability studies managed by Global BioPharmaceutical Stability and for overall department administration support.

Duties/Responsibilities Key activities:
• Supports stability team by managing stability study inventory, including receipt of samples from manufacturing site, placing samples at the appropriate conditions per approved protocols, managing timepoint pull schedules and samples pulls with the testing labs, storage unit maintenance, inventory control, sample destructions, sample pulls and deliveries, inventory management and reconciliation. Assists with review of stability data and trends.
• Supports identifying stability annual requirements from the manufacturing site via stability annual requirement documents and enrollment document.
• Support stability program activity execution for the current and new products.
Engage with generation of sample management program and logistics, master
stability protocol, stability study protocol. Review stability study LIMS build for
accuracy with respect to sample management.
• Identify, write, and revise applicable SOPs for managerial review and approval.
• Write applicable technical reports section for sample storage and sample
management pull information for OOS/OOT investigations as needed.
• Write and revise annual stability requirement documents (PAR/QSR, SAR/YER).
• Escalate information regarding stability program management that may impact lab capacity, product studies or regulatory commitments directly and promptly to management.
• Provide team training need for ongoing stability activities. Ensure training
requirements are met.
• Works according to cGMP requirements and HA expectations.
• Can effectively interact with inspectors during facility tours.
• Supports stability storage chamber maintenance by working with third party
contractors and site maintenance personnel, providing entry of work orders in

designated systems, maintaining, and reviewing environmental charts and log
sheets and responding to chamber related events.
• Enters test results from contract laboratories into the stability study management systems.
• Provides administration support for department training, financial, filing, and
archiving processes.

These key activities provide support in order for the department to achieve defined company and business goals.
Reporting Relationship Reports to Director, Global Biopharmaceutical Stability Operations

Qualifications Education:
• Bachelors Degree in Chemistry, Microbiology, or other related scientific
discipline
Experience/Knowledge:
• Experience with stability programs desired.
• Solid understanding and knowledge of cGMPs and regulatory principles.
Skills/Competencies:
• Excellent verbal, written, and interpersonal communication skills are essential.
• Able to work independently and as part of a team-based environment.
• Proficient computer software application skills.
• Demonstrated ability for accurate recordkeeping, thorough documentation,
attention to detail, and efficient organization/management of records and time.

#LI-Hybrid

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:

New Brunswick - NJ - US: $85,210 - $103,258

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.