Role Summary
The Director of Analytical Development leads the development and validation of analytical methods for both early and late-stage molecules, ensuring phase-appropriate solutions, regulatory alignment, and cross-functional support for process development, formulation, CMC, and quality activities. This role requires deep technical expertise, proven leadership, and the ability to operate effectively in a fast-paced, growth-stage biotech environment. 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 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 Additional Requirements
Travel: 10% of time
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The Director of Analytical Development leads the development and validation of analytical methods for both early and late-stage molecules, ensuring phase-appropriate solutions, regulatory alignment, and cross-functional support for process development, formulation, CMC, and quality activities. This role requires deep technical expertise, proven leadership, and the ability to operate effectively in a fast-paced, growth-stage biotech environment. 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 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 Additional Requirements
Travel: 10% of time
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