Director, Analytical Development/CMC

  • 170000 USD - 220000 USD
  • Thousand Oaks, United States
  • Permanent

We are searching for a Director of Analytical Development/CMC to lead our preclinical to clinical analytical development activities. Preference given to applicants able to work from Thousand Oaks, CA office.


Primary responsibilities:

  • Oversee the design and execution of phase-appropriate analytical strategies at contract manufacturers/service providers including analytical method development, qualification and validation for drug substance and drug product.
  • Develop and set specifications for raw materials, intermediates, drug substance, excipients and drug product.
  • Design and manage stability programs for non-GMP and cGMP drug substance and drug product batches and provide guidance for shelf-life and expiry dating.
  • Author, review and approve various analytical reports to support drug substance and drug product development and manufacture, and regulatory filings.
  • Support regulatory submissions by drafting and reviewing analytical sections of INDs, IMPDs, and NDAs, and ensure compliance with current regulatory requirements.
  • Review/approve controlled cGMP documents
  • Manage/perform QC review/approval of analytical test data for IPC testing, drug substance/product batch release and stability test data.
  • Manage and review deviation events and OOS/OOT investigations in coordination with CMC counterparts, QA and regulatory team members.
  • Contribute to the building of CMC infrastructure and company culture.


Basic Qualifications:

  • PhD in analytical chemistry or related discipline with at least 10 years of industry experience OR BS/MS degree with more than 15 years industry experience.
  • Experience with analytical development of small molecules and drug product oral dosage forms from preclinical to late-stage clinical development.
  • Extensive experience managing drug substance and drug product service providers in analytical matters.
  • Experience with identification and qualification of impurities and degradation products.
  • Experience with setting specifications for drug substance and drug product and qualification of reference standards.
  • Extensive knowledge of GLP and cGMP requirements, appropriate regulatory guidance and current industry practices for analytical development. and current industry practices for analytical development.
  • Experience in writing CMC sections for Regulatory submissions (IND experience required; NDA experience highly desirable).
  • Strong understanding of solid state properties of small molecules.
  • Ability to travel domestically and internationally.


Reach out to learn more:



Alanah Gaudreau Resourcer

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