Senior Scientist, Quality Control

Experience

• Experience with Commercial Quality Control with knowledge of industry best practices and trends for reference standards, stability and/or raw materials.
• In-depth understanding and application of GMP principles, concepts, practices and standards in the US and internationally.
• Must be able to develop and improve complex concepts, techniques, standards and new applications based on quality principles and theories.
• Must be able to develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovation.
• Must be able to exercise judgment and independently determine and take appropriate action where precedent may not exist.
• Proven ability to work with senior management to develop and ensure the implementation of Company-wide long-term solutions.
• Demonstrated an ability to develop a vision for Quality Control functions and have shaped the capabilities of the function to fulfill that vision.
• Demonstrated the ability to influence process and outcomes across functions.

• Serve as the primary QC representative for assigned products, providing QC leadership and analytical subject matter expertise across product and analytical sub-teams, PDM teams, PQTs, and other cross-functional forums.
• Provide end-to-end QC oversight for assigned products, coordinating QC activities and deliverables across manufacturing, testing, analytical methods, stability, regulatory submissions, and commercial lifecycle activities.
• Lead oversight of contract testing laboratory activities, including testing execution, GMP sample shipment coordination, laboratory investigations and deviations, change controls, and resolution of testing-related issues.
• Provide analytical and QC input to manufacturing investigations and deviations, partnering with Manufacturing, Quality, technical functions, and testing laboratories to assess product and method impact and support appropriate resolution.
• Lead lifecycle management of analytical methods and associated QC testing strategies, including method implementation, transfer, validation/verification, changes, performance monitoring, and continued suitability for commercial testing.
• Provide QC input and review for regulatory submissions and post-approval changes, including BLA/NDA content, responses to regulatory questions, and assessment of QC impacts associated with filing commitments.
• Coordinate the review and approval of commercial specifications and associated testing requirements, ensuring alignment with regulatory filings, analytical capabilities, product knowledge, and applicable quality requirements.
• Provide QC oversight and coordination for product changes, assessing impacts to analytical methods, specifications, testing laboratories, sample management, stability, and other QC deliverables and ensuring appropriate implementation.
• Partner cross functionally with Quality Control, Quality Assurance, Manufacturing, Regulatory, Supply Chain and other technical functions to ensure QC deliverables, risks, dependencies, and issues are appropriately identified, communicated, and managed throughout the product lifecycle.
• Serve as a QC subject matter expert and technical escalation point, providing recommendations, driving resolution of analytical and testing issues, and communicating QC risks, decisions, and priorities to cross-functional stakeholders.
• Author, review, and maintain GMP documentation, including protocols, reports, SOPs, deviations, change controls, CAPAs, and study closeout documentation.