Associate Stability Scientist

About the role

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.

Responsibilities

• Supports stability strategy team by managing stability study inventory via third party storage company, 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.
• Supports stability program activity execution for the current and new products.
• Engages with generation of sample management program and logistics, master stability protocol, stability study protocol.
• Reviews stability study LIMS build for accuracy with respect to sample management.
• Identifies, writes, and revises applicable SOPs for managerial review and approval.
• Writes applicable technical reports section for sample storage and sample management pull information for OOS/OOT investigations as needed.
• Writes and revises annual stability requirement documents (PAR/QSR, SAR/YER).
• Escalates information regarding stability program management that may impact lab capacity, product studies or regulatory commitments directly and promptly to management.
• Ensures training requirements are met.
• Works according to cGMP requirements and HA expectations.
• Effectively interacts with inspectors during facility tours.
• Supports third party storage facility.
• Enters test results from contract laboratories into the stability study management systems.
• Provides administration support for department training, financial, filings, and archiving processes.

Requirements

• Bachelor’s Degree in Chemistry, Microbiology, or other related scientific discipline.
• Experience with stability programs desired.
• Solid understanding and knowledge of cGMPs and regulatory principles.

Skills

• Excellent verbal, written, and interpersonal communication skills.
• 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.

Pay

Devens - MA - US: $91,180 - $110,488 (full-time employee basis). Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life Benefits:
  • US Exempt Employees: Flexible time off (unlimited, with manager approval), 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico, or Rayzebio employees).
  • Phoenix, AZ, Puerto Rico, and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays.
  • Based on eligibility, additional time off may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs, and an annual Global Shutdown between Christmas and New Year’s Day.

All global employees (full and part-time) who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

Schedule

BMS has an occupancy structure that determines where an employee is required to conduct their work. This role is site-by-design, which may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. Onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive company culture.