Principal Scientist Stability

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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.

Major Duties and Responsibilities

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 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 the handling of annual commercial stability program for assigned products in coordination with sample management groups.

• Authors stability sections of CTD dossiers for post-approval 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

Education:                                            

B.S. Chemistry, Biology, Microbiology or relevant discipline

Experience/Knowledge:          

• 8 years of relevant work experience required, preferable in a    Pharmaceutical environment           

• Expert knowledge and understanding 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 of US/EU/ROW Requirem