Stability Scientist

3 weeks ago

New Brunswick, United States TSR Consulting Services, Inc. Full time

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

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