Stability Principle Scientist
vor 2 Wochen
Working with Us
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 rich in diversity.
Take your career farther than you thought possible.
The Principal Scientist Stability is responsible for stability product strategy and oversight of product stability programs for commercial small molecules 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.
The Principal Scientist stability is accountable for the 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 postapproval 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 the handling of annual commercial stability program for assigned products in coordination with sample management groups.
- Authors stability sections of CTD dossiers for postapproval filings, annual reports, product renewals, Annual Product Stability 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.
- Identify information regarding stability program that may impact lab capacity, product studies or regulatory commitments directly, escalate promptly to management and act as required.
- Responsible for stability procedures and ensures consistency with site department and BMS groups procedures.
- Participate and/or lead OpEx initiatives to streamline and standardize management of stability programs
- Support health authorities inspection internal and external.
- Represents department in cross functional projects
- Ensure training requirements are met.
- Acts as an advisor and mentor to stability staff
_ Required Knowledge/Skills/Qualifications_
- B.S. Chemistry, Biology, Microbiology or relevant discipline
- 8 years of relevant work experience required, preferable in a Pharmaceutical environment
- Expert Knowledge of 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.
- Very good skills to drive development of technical or scientific initiatives for solving complex problems/issues; recommending and drive sciencebased decisions/ implementation of solutions.
- Experience with authorship and able to critically review investigations, interpret results, and generate technical conclusions consistent with Quality management principles
- Good Knowledge of evaluation and interpretation of stability data using statistics software. Review data and demonstrated ability to recognize anomalous trends or results
- Experience to oversee external service providers involved in stability studies.
- Significant experience on health authorities 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 ability to adapt to quick changes in schedules in order to accommodate priority requests.
- Adva
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