Role summarythe 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.responsibilitiesoversee analytical method development, qualification, and validation for starting materials, in-process control, process intermediates, drug substances and drug productsconduct analytical technical review of method validation/qualification protocols, data and reports generated at cdmos for drug substances and drug productsreview and approve analytical reports or certificates of analyses from cdmos for batch release and stability testing of drug substances and drug productsmanage stability programs, monitor trending stability data and establish retest periods or shelf lives for drug substances or drug productsprovide technical input and resolve analytical and quality control issues, deviations, oos and oot investigationsauthor and review appropriate cmc sections to support regulatory filings (ind, impd, nda, maa) submissionsrepresent analytical chemistry at internal and external scientific team meetings as neededremain current with state-of-the art approaches and applicable global regulations and industry standardsqualificationsphd 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 registrationminimum of 5 years direct leadership experience on managing internal and external teamsexpertise of cgmp, ich, and fda regulations/guidancedemonstrated 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 milestonesexperience in partnering with cross functional teams providing analytical development leadership across programs and projectsdemonstrated interpersonal skills, including strong oral and written communication abilitiesskillsa high level of curiosity, intelligence, ability to work independently, “can do” attitude, and ability to work cross-functionallyaspires to the highest of scientific and ethical standardsability to multi-task and shift priorities rapidly to meet tight deadlineskeen to improve processes and overcome inefficiencieseducationphd or ms in a relevant field with extensive experience in small molecule drug substance and drug product analytical development and quality controladditional requirementslocation: san francisco or boston, with 10% travel
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