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Product Stability Manager

2 months ago

Nebraska, United States Innova Solutions Full time
Job Summary

Innova Solutions is seeking a highly skilled Stability Principal Scientist to join our team. As a key member of our organization, you will be responsible for leading our product stability programs and ensuring compliance with regulatory requirements.

Key Responsibilities
  • Develop and implement product stability strategies to ensure compliance with ICH guidelines and cGMP regulations.
  • Lead cross-functional teams to design and execute stability studies, including gap analysis and data development.
  • Collaborate with regulatory affairs to ensure compliance with US/EU/ROW requirements and corporate directives.
  • Develop and maintain expertise on the overall stability performance of products manufactured in the global supply chain.
  • Serve as stability representative on project teams, including post-approval changes and premarket stability programs.
  • Perform change control impact assessments and document stability assessments in change controls.
  • Review and endorse change controls as an expanded reviewer.
  • Initiate change controls related to stability operations.
  • Provide technical requirements in Master Stability Protocols and review/approve study-specific protocols and batch enrollment forms.
  • Responsible for handling annual commercial stability programs for assigned products in coordination with sample management groups.
  • Author stability sections of CTD dossiers for post-approval filings, annual reports, product renewals, and stability-related responses to health authority inquiries.
  • Serve as stability representative for OOT/OOS investigations, Market Action Fact Finding, and other investigations related to potential quality issues and/or deviations from standards.
  • Lead work activities involving Change Controls and CAPAs.
  • Identify information regarding stability programs 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 client 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.
Requirements
  • Education: B.S. in Chemistry, Biology, Microbiology, or relevant discipline.
  • Experience: 8+ years of experience in stability program management for small molecules (oral and sterile products).
  • Strong understanding of stability ICH guidelines and cGMP regulations.
  • Very good experience in New Product Introduction.
  • Very good understanding of regulatory CMC, US/EU/ROW submission requirements for stability.
  • Hand-on experience in handling QC Deviation OOS/OOT, authorship, interpret results.
  • 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.
  • Experience to oversee external service providers involved in stability studies.
  • Significant experience on health authorities inspections on stability programs.
  • Advanced knowledge of Microsoft Office applications, LIMS, Quality Management system (e.g., TrackWise or Veeva), Statistics software (e.g., SlimSTAT, JMP).
Benefits

Innova Solutions offers benefits (based on eligibility) that include:

  • Medical & pharmacy coverage
  • Dental/vision insurance
  • 401(k)
  • Health saving account (HSA) and Flexible spending account (FSA)
  • Life Insurance
  • Pet Insurance
  • Short-term and Long-term Disability
  • Accident & Critical illness coverage
  • Pre-paid legal & ID theft protection
  • Sick time
  • Other types of paid leaves (as required by law)
  • Employee Assistance Program (EAP)