Bristol Myers Squibb · 11 hours ago
Senior Scientist Stability
Devens, MA
Full-time
Onsite
Senior Level
$116K/yr - $140K/yrBristol Myers Squibb is a company dedicated to transforming patients' lives through science. The Stability Senior Scientist is responsible for overseeing commercial drug substance and drug product stability programs, including developing stability strategies, analyzing stability data, and managing regulatory submissions.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
Stability product strategy determines/communicates stability requirements (e.g. Health Authority annual commitments, product/process change qualification batches, etc.) and assists with identifying production batches that meet these defined requirements for inclusion in the stability program
Perform change control impact assessments and document the assessments in change controls. Review and endorse change controls as required
Author change controls for changes to stability program/operations
Review/approve creation/modifications to Master Stability Protocols (MSP) and Study-Specific Protocols (SSP), batch-specific enrollment documentation, and LIMS stability studies
Perform stability data analysis/trending in support of data out-of-trend (OOT) analyses, regulatory submissions, Annual Product Quality Reviews (APQR), internal reports, etc
Authors stability sections of regulatory submissions (CTD dossiers for post-approval filings, annual reports, product renewals, health authority queries), APQR, and internal reports
Serve as stability subject-matter expert (SME) on project teams related to pre-market and post-approval changes
Develop and maintain expertise on the overall stability performance of biologic products, including maintaining a working knowledge of the attributes that impact product performance/stability profile
Serves as GBS representative for OOT/OOS investigations and other stability-related investigations/deviations. Complete stability impact assessments as needed
Expected to work with limited oversight from direct manager; but expected to identify and promptly escalate to management any critical issues related to stability program (e.g. potential impact to regulatory commitments, lab capacity, stability storage capacity)
Expected to critically evaluate situations and make decisions that require choosing between multiple options, or develop new options, to resolve moderately complex problems
Acts as an advisor/mentor to stability staff
Good organization skills and keen attention to detail
Qualification
Required
End-to-end oversight of commercial drug substance and drug product stability programs
Developing product stability strategy
Stability data analysis/trending
Preparation, review and approval of stability protocols, reports and regulatory filings
Stability product strategy determines/communicates stability requirements
Perform change control impact assessments and document the assessments in change controls
Review and endorse change controls as required
Author change controls for changes to stability program/operations
Review/approve creation/modifications to Master Stability Protocols (MSP) and Study-Specific Protocols (SSP)
Perform stability data analysis/trending in support of data out-of-trend (OOT) analyses
Authors stability sections of regulatory submissions
Serve as stability subject-matter expert (SME) on project teams
Develop and maintain expertise on the overall stability performance of biologic products
Serves as GBS representative for OOT/OOS investigations
Complete stability impact assessments as needed
Work with limited oversight from direct manager
Identify and promptly escalate to management any critical issues related to stability program
Critically evaluate situations and make decisions that require choosing between multiple options
Acts as an advisor/mentor to stability staff
Good organization skills and keen attention to detail
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.
Paid Time Off
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
Additional time off for employees 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 Years Day.
Company
Bristol Myers Squibb
At Bristol Myers Squibb, we work every day to transform patients’ lives through science.
Founded in 1887
10001+ employees
H1B Sponsorship
Bristol Myers Squibb has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (247)
2024 (278)
2023 (231)
2022 (180)
2021 (181)
2020 (169)
Funding
Current Stage
Public CompanyTotal Funding
$29.32BKey Investors
Venrock
2025-11-05Post Ipo Debt· $5.74B
2024-02-14Post Ipo Debt· $13B
2023-10-30Post Ipo Debt· $4.5B
Leadership Team
Charles Bancroft
CFO
Cristian Massacesi
Executive Vice President, Chief Medical Officer and Head of Development
Recent News
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