Principal Scientist Stability

Bristol Myers Squibb•New Brunswick, NJ

1d•$121,520 - $147,249•Onsite

About The Position

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. Position Summary The Principal Scientist Stability is responsible for stability product strategy and oversight of product stability programs for commercial large molecule Drug Substances and Drug Products. Activities include those associated with product stability strategy, stability program requirements, authoring / approving stability protocols, and preparation, review and approval of stability reports and regulatory filings. Responsibilities include supporting stability operations and logistics where needed to provide experienced guidance and continuing execution to run the business.

Requirements

B.S. Chemistry, Biology, Microbiology, or relevant discipline.
8 years of relevant work experience required, preferably in a pharmaceutical environment.
Expert knowledge of stability ICH Guidelines (Q1A, Q5C) and associated policies, directives and guidance documents. A thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to stability programs in a pharmaceutical manufacturing facility.
Expert knowledge in US/EU/ROW Requirements, Corporate Directives and industry best practices.
Knowledge of Drug Substance and Drug Product manufacturing and good understanding of analytical and/or Microbiology methods.
Outstanding skills to drive development of technical or scientific initiatives for solving complex problems/issues, recommending and drive science-based decisions/ implementation of solutions.
Experience with authorship and able to critically review investigations, interpret results, and generate technical conclusions consistent with Quality management principles.
Expert knowledge of evaluation and interpretation of stability data using statistics software. Review data and demonstrated ability to recognize anomalous trends or results.
Significant experience in overseeing external service providers involved in stability studies.
Significant experience on health authority inspections on stability programs.
Excellent written and verbal communication skills.
Exhibit strong leadership and decision-making skills.
Advanced ability to work independently and collaboratively in a team matrix environment, contribute to a team-based environment, promoting a high commitment to business goals and objectives.
Advanced ability to prioritize objectives from multiple projects and adapt to quick changes in schedules to accommodate priority requests.
Advanced knowledge of Microsoft office applications, LIMS (Laboratory Information Management System), Quality Management system (e.g. TrackWise or Veeva), Statistics software (e.g. SlimSTAT, JMP).

Responsibilities

The Principal Scientist Stability is accountable for the commercial biologics stability program on assigned brand(s) and acts as Stability Product Lead.
Participates on transfer team for new products to internal and external sites (as required), reviews registrational stability studies and conducts gap analysis against Global Manufacturing & Supply requirements. Develops stability data where gaps exist.
Develops and maintains expertise on the overall stability performance of products manufactured in the global supply chain, including maintaining a working knowledge of the attributes that impact the products’ performance/stability profile.
Serves as stability representative on project teams covering post-approval changes, designs and executes required premarket stability program in support of the change.
Perform change control impact assessments and document the stability assessment in change controls. Review and endorse change controls as an expanded reviewer. Initiate change controls related to stability operations.
Provide the technical requirements in a Master Stability Protocol, review and approve study specific protocols and / or batch enrollment forms.
Responsible for handling annual commercial stability program for assigned products in coordination with sample management groups.
Responsible for providing experienced guidance and continuing execution to run the business.
Authors stability sections of CTD (Common Technical Document) dossiers for post-approval filings, annual reports, product renewals, Annual Product Quality Reviews, and stability related responses to health authority inquiries.
Serves as stability representative for OOT/OOS investigations, Market Action Fact Finding, and other investigations related to potential quality issues and/or deviations from standards.
Leads work activities involving Change Controls and CAPA’s.
Responsible for stability procedures and ensures consistency with site department and BMS groups procedures.
Participate and/or lead OpEx (Operational Excellence) initiatives to streamline and standardize management of stability programs.
Supports health authority inspections, internal and external.
Independently represents department in cross functional projects.

Benefits

wellbeing support
retirement and financial protection benefits
insurance offerings (medical, dental, vision, life and disability)
Flexible Time Off (FTO)
11 paid company holidays
160 hours of paid vacation annually
3 optional holidays
paid sick leave
up to two paid volunteer days per year
summer hours flexibility
leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
annual Global Shutdown between Christmas Day and New Year's Day