Position SummaryThe 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.
Key ResponsibilitiesThe 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.
Qualifications & Experience- 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).
We hire for skills and capabilities, not just credentials - if this role excites you, but doesn't perfectly match your resume, we encourage you to apply anyway.
Compensation Overview:New Brunswick - NJ - US: $121,520 - $147,249
The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully - carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.
Benefits:Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans - including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits
How We WorkWhere you work matters - because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.
