Stability Scientist-Operations Full-time NEW

Stability Scientist-Operations

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.

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 activities:

• 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 support 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.
• 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.

Qualifications, Knowledge and Skills Required:

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.

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.

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 patients' lives through science™ “, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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R1602193 : Stability Scientist-Operations