Associate Stability Scientist

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . 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.

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. If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming