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
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