TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence.
Our client, a leading pharmaceutical company is hiring a Stability Scientist on a contract basis. Please only local candidates to New Brunswick NJ. 8 years of relevant work experience required in a Pharmaceutical environment.
Work Location: New Brunswick NJ
Pay: $77-79/hour W2
Required Skills: • 8+ years of experience in Stability Program Management for small molecules (oral and sterile product) • Strong understanding of stability ICH guidelines and cGMP regulation • Very good experience on New Product Introduction • Very good understanding on Regulatory CMC , US/EU/ROW submission requirement for stability • Hand on experience on handling QC Deviation OOS / OOT, authorship , interpret results • Responsible for stability product strategy and oversight of product stability
programs for commercial small molecules Drug Substances and Drug Products Oral and Sterile • 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 • 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 • 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 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 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 • Good Knowledge of evaluation and interpretation of stability data using
statistics software • Review data and demonstrated ability to recognize anomalous trends or results • Significant experience on health authorities inspections on stability programs