Sr Director Analytical Development

Role Summary

Senior Director, Analytical Development overseeing analytical development from early-stage to commercialization, providing strategic leadership for management of CDMOs and transfer of analytical methods for drug substances and drug products. Build and motivate a collaborative team with subject matter expertise and ensure compliance with applicable laws, regulations, and guidelines to support regulatory filings worldwide. Reports to the Executive Director, Chemical Development.

Responsibilities

• 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

Qualifications

• PhD or advanced degree in Analytical or Organic Chemistry, Pharmaceutical Sciences, or related field with 10+ years of hands-on experience with increasing responsibility in pharmaceutical development
• 10+ years of contract laboratory relationship management and 5+ years in significant leadership roles
• Strong knowledge of cGMP, ICH guidelines, regulatory requirements, quality systems and industry standards such as USP, Ph.Eur., JP
• Extensive experience in analytical method development for small molecule DS and DP, especially late-stage method development and enabling studies for regulatory filings
• Ability to multi-task, prioritize, and manage time effectively
• Intermediate to advanced software skills (e.g., Microsoft Excel, PowerPoint, MS Project)
• High attention to detail and accuracy with strong oral and written communication skills
• Flexibility in a rapidly changing environment; capable of working in a goal- and team-oriented setting
• Well-developed organizational skills and ability to work in a fast-paced environment