Senior Scientist Stability

Bristol Myers Squibb•Devens, MA

1d•$108,210 - $140,307•Onsite

About The Position

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. The Stability Senior Scientist reports to the Associate Director of Global Biologics Stability and is responsible for end-to-end oversight of commercial drug substance and drug product stability programs. Activities include (but not limited to) those associated with developing product stability strategy; stability data analysis/trending; and preparation, review and approval of stability protocols, reports and regulatory filings. The Stability Senior Scienstit is accountable for end-to-end program management for biologics marketed product stability program, including: 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. #LI-ONSITE 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.

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.

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 include: 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 Based on eligibility, 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.

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