Associate Stability Scientist

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.

Key Responsibilities

• Support 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.
• Assist with review of stability data and trends.
• Support identifying stability annual requirements from the manufacturing site via stability annual requirement documents and enrollment document.
• Support stability program activity execution for 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 technical report sections 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 for ongoing stability activities and ensure training requirements are met.
• Work according to cGMP requirements and HA expectations; interact effectively with inspectors during facility tours.
• Support stability storage chamber maintenance by coordinating with third‑party contractors and site maintenance personnel, entering work orders, maintaining and reviewing environmental charts and log sheets, and responding to chamber‑related events.
• Enter test results from contract laboratories into the stability study management systems.
• Provide administration support for department training, financial, filing, and archiving processes.

Reporting Relationship

Reports to Director, Global Biopharmaceutical Stability Operations.

Qualifications

• Bachelor’s Degree in Chemistry, Microbiology, or other related scientific discipline.
• Experience with stability programs desired.
• Solid understanding and knowledge of cGMPs and regulatory principles.

Skills and Competencies

• Excellent verbal, written, and interpersonal communication skills.
• Ability 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.

Compensation

New Brunswick, NJ – US $85,210 – $103,258 (full‑time). May be eligible for additional discretionary incentive cash and stock opportunities. Pay is determined based on role, skills, location, schedule, and experience, guided by pay equity principles and applicable laws.

Benefits

Eligible to participate in 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 receive Flexible Time Off (FTO) with no set accrual limit, subject to manager approval, plus 11 paid company holidays. Non‑exempt employees, RayzeBio employees, and employees in Puerto Rico receive 160 hours of paid vacation annually for new hires, 11 paid company holidays, and 3 optional holidays. Additional time‑off benefits may include paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and various leaves of absence (medical, personal, parental, caregiver, bereavement, military). Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.

Work Model

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. More information is available at the company’s “Ways of Working” page.