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@peoplewithchemistry.com

858-429-6147