Director, Analytical Development

Role Summary

Director of Analytical Development responsible for driving progress of both early and late-stage molecules by delivering phase-appropriate analytical methods and validation. Lead method innovation, ensure alignment with regulatory expectations, and partner cross-functionally to support process development, formulation, CMC, and quality activities. Based in San Francisco or Boston with 10% travel.

Responsibilities

• Oversee analytical method development, qualification, and validation for starting materials, in-process control, process intermediates, drug substances and drug products
• Conduct analytical technical review of method validation/qualification protocols, data and reports generated at CDMOs for drug substances and drug products
• Review and approve analytical reports or certificates of analyses from CDMOs for batch release and stability testing of drug substances and drug products
• Manage stability programs, monitor trending stability data and establish retest periods or shelf lives for drug substances or drug products
• Provide technical input and resolve analytical and quality control issues, deviations, OOS and OOT investigations
• Author and review appropriate CMC sections to support regulatory filings (IND, IMPD, NDA, MAA) submissions
• Represent Analytical Chemistry at internal and external scientific team meetings as needed
• Remain current with state-of-the art approaches and applicable global regulations and industry standards

Qualifications

• Required: PhD with a minimum of 10+ years of relevant industry experience or an MS with a minimum of 12+ years of relevant industry experience in small molecule drug substance and drug product analytical development and quality control, including late-stage clinical development and preparation for product registration
• Required: Minimum of 5 years direct leadership experience on managing internal and external teams
• Required: Expertise of cGMP, ICH, and FDA regulations/guidance
• Required: Demonstrated experience in authoring and reviewing documents in support of CMC development activities and regulatory submissions (IND/IMPD, information requests, amendments, briefing books, NDA/MAA, etc.)
• Required: Experience in developing internal technical capabilities and driving CDMO performance to meet critical project milestones
• Required: Experience in partnering with cross functional teams providing analytical development leadership across programs and projects
• Required: Demonstrated interpersonal skills, including strong oral and written communication abilities
• Preferred: A high level of curiosity, intelligence, ability to work independently, “can do” attitude, and ability to work cross-functionally. Strong initiative and follow-through are essential for this role
• Preferred: Aspires to the highest of scientific and ethical standards
• Preferred: Ability to multi-task and shift priorities rapidly to meet tight deadlines
• Preferred: Keen to improve processes and overcome inefficiencies

Education

• PhD with a minimum of 10+ years of relevant industry experience or MS with a minimum of 12+ years of relevant industry experience in small molecule drug substance and drug product analytical development and quality control

Additional Requirements

• Travel: 10% travel required