Role summary the director of analytical development, reporting to the senior director, analytical chemistry, drives progress of both early and late-stage molecules by delivering phase-appropriate analytical methods and validation. Leads method innovation, ensures alignment with regulatory expectations, and partners cross-functionally to support process development, formulation, cmc, and quality activities. Role is 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 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 minimum of 5 years direct leadership experience on managing internal and external teams expertise of cgmp, ich, and fda regulations/guidance 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.) Experience in developing internal technical capabilities and driving cdmo performance to meet critical project milestones experience in partnering with cross functional teams providing analytical development leadership across programs and projects demonstrated interpersonal skills, including strong oral and written communication abilities skills a high level of curiosity, intelligence, ability to work independently, “can do” attitude, and ability to work cross-functionally aspires to the highest of scientific and ethical standards ability to multi-task and shift priorities rapidly to meet tight deadlines keen to improve processes and overcome inefficiencies education phd or ms in a relevant field with extensive experience in small molecule drug substance and drug product analytical development and quality control additional requirements location: san francisco or boston, with 10% travel j-18808-ljbffr