Associate Stability Scientist

Bristol Myers Squibb EU Policy; Boudry; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

Bristol Myers Squibb is seeking an Associate Stability Scientist to support stability activities and documentation in a cGMP environment. The role emphasizes data integrity, sample management, and collaboration with internal teams and external labs.

The position focuses on stability study execution, SOP maintenance, and accurate reporting, contributing to regulatory readiness and product quality across stability programs.

Qualifikationen

• Experience with stability programs desired.
• Solid understanding of cGMPs and regulatory principles.

Aufgaben

• Manage stability study inventory and sample handling.
• Review stability data and trends.
• Write and revise SOPs for stability program.
• Enter test results into stability study management systems.
• Coordinate training for stability activities.

Kenntnisse

Communication

Documentation

Detail-oriented

Independence

Teamwork

MS Office

Ausbildung

Bachelor's degree in Chemistry/Microbiology or related science

Jobbeschreibung

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.

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.

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.

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.

On-site Protocol

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.

Supporting People With Disabilities

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 [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

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/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at [e-mail]. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1604730 : Associate Stability Scientist