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This is work that transforms the lives of patients, and the careers of those who do it.

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