Stability Principal Scientist

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.

• 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.
• Represent department in cross-functional projects.
• Ensure training requirements are met.
• Acts as an advisor and mentor to stability staff.

• 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 deviations, OOS/OOT, authorship, and interpreting results.

• Expert knowledge and understanding of stability ICH guidelines (Q1A, Q5C) and associated policies, directives, and guidance documents.
• 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 driving 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).