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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
Oversees and 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.
Oversees and 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.
Support 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.
Enter test results from contract laboratories into the stability study management systems.
Provides administration support for department training, financial, filing, and archiving processes.
Qualifications, Knowledge And Skills Required
Education
Bachelor’s 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 record‑keeping, thorough documentation, attention to detail, and efficient organization/management of records and time.
Why you should apply
You will help patients in their fight against serious diseases.
You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
You’ll get a competitive salary and a great benefits package including, but not only, an annual bonus, pension contribution, family health insurance, 27 days of annual leave, access to BMS Cruiserath on‑site gym and life assurance.
Based on your function, department or individual position, you will have the opportunity to discuss with your Manager the option to work remotely up to 50% of the time, over a two‑week period, with the flexibility to choose the days that align with your collaboration needs.
Candidate Rights
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
R1602193 Stability Scientist-Operations
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