Zentalis Pharmaceuticals

Director

• Lead Analytical Development activities for all drug candidates from early-stage development through commercialization.
• Provide strategic leadership to internal team members for the management of CDMOs to develop, validate and transfer analytical methods for drug substances and drug products in support of clinical and commercial supply.
• Build and motivate a collaborative team with exceptional subject matter expertise.
• In cooperation with Quality and Regulatory functions, ensure operations are compliant with applicable laws, regulations, and guidelines to ensure patient safety and support for regulatory filings worldwide.
• Independently lead and manage analytical development projects and provide strategic insights to interdepartmental functions
• Establish testing methodology and specifications for raw materials, intermediates, excipients, drug substances, and drug products
• Lead group of resources responsible for development of stability programs for both DS and DP, including trend analysis
• Develop science-driven, phase appropriate, and risk-based analytical methods and control strategies to support Zentalis programs at each stage of development.
• Oversee the review of protocols, reports, and raw data for analytical method validation and transfer, release and stability testing
• Direct the establishment and management of reference standard programs
• Collaborate with Drug Substance, Drug Product, Supply Chain, Quality, Regulatory, Clinical, Pre-clinical, and Program Management to achieve program goals.
• Support QA on quality system and compliance activities, including audit functions
• Develop, mentor and coach members of the analytical team to enhance their technical capabilities.
• Independently plan and oversee execution of experimental and developmental projects
• Direct implementation of product specifications at vendors and for regulatory filings
• Provide timely technical and stability report summaries to management
• Review and approve analytical methods, specifications, change controls, deviation, investigation, out-of-trend, out-of-specification reports, and other analytical related documents
• Author and review appropriate development reports, regulatory filings and related sections in support of the company regulatory interactions.
• Travel to CDMOs for technical meetings, vendor assessment, qualification, and oversight of analytical activities.

Senior Director, Analytical Development