Associate Stability Scientist

Bristol Myers Squibb Celgene seeks an Associate Stability Scientist in Boudry, CH, to manage stability studies, ensure regulatory compliance, and support the stability team in achieving business goals.

This position supports the stability team and contributes to achieving defined company and business goals. The role involves supporting stability program activity execution for current and new products.

Responsibilities

• Oversee stability study inventory, including sample receipt, placement under specific conditions, timepoint scheduling, inventory control, and reconciliation.
• Assist in reviewing stability data and identifying trends.
• Identify stability annual requirements from the manufacturing site via stability annual requirement documents and enrollment document.
• Engage with generation of sample management program, logistics, master stability protocol, and 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).
• Provide team training need for ongoing stability activities and ensure training requirements are met.
• Support stability storage chamber maintenance by working with third party contractors and site maintenance personnel, providing entry of work orders, maintaining 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.

Requirements

• Bachelor's Degree in Chemistry, Microbiology, or other related scientific discipline.
• Solid understanding and knowledge of cGMPs and regulatory principles.
• Works according to cGMP requirements and HA expectations.
• Can effectively interact with inspectors during facility tours.

Nice to have

• Experience with stability programs.

What the company offers

• A wide variety of competitive benefits, services and programs.
• Opportunities to grow and thrive alongside high-achieving teams.
• Recognition of the importance of balance and flexibility in the work environment.

About the company

The company culture is supportive, promoting global participation in clinical trials and shared values of passion, innovation, urgency, accountability, inclusion and integrity. The company vision is to transform patients' lives through science. The company is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process and reasonable workplace accommodations.

• Supportive culture promoting global participation in clinical trials.
• Shared values of passion, innovation, urgency, accountability, inclusion and integrity.
• Vision to transform patients' lives through science.
• Dedicated to ensuring that people with disabilities can excel through a transparent recruitment process and reasonable workplace accommodations.