Sr Director Analytical Development

Role Summary

Lead Analytical Development activities for all drug candidates from early-stage development through commercialization. Provide strategic leadership for managing contract development and manufacturing organizations to develop, validate and transfer analytical methods for drug substances and drug products. Build and motivate a collaborative, subject-matter-expert team. In cooperation with Quality and Regulatory functions, ensure operations comply with applicable laws, regulations, and guidelines to ensure patient safety and support regulatory filings worldwide. This role 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 role(s) of multifunctional teams
• 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 time management of daily activities.
• Intermediate to advanced software skills (e.g., Microsoft Excel, PowerPoint, MS Project).
• High attention to detail.
• Demonstrates a high level of accuracy and effective oral and written communication skills.
• Flexibility within a rapidly changing environment.
• Excellent ability to work in a goal and team-oriented setting.
• Well-developed organizational skills and the ability to work in a fast-paced environment