Job: Associate Director/Principal Scientist, CMC Analytical Chemistry
Location: San Francisco, CA or Thousand Oaks, CA
Position type: Full Time
Reports to: Director of Analytical Chemistry
Position Summary
Latigo is searching for an Associate Director/Principal Scientist, CMC Analytical Chemistry. Reporting to the Director of Analytical Chemistry, the candidate will manage preclinical to clinical analytical development activities and oversee the testing and release of drug substance and drug product at contract manufacturers/service providers. The role is responsible for the development, validation and implementation of QC methods for drug substance, drug product, intermediates, starting materials, excipients, and packaging materials at contract manufacturers.
Additional responsibilities include reference standard qualification and management, establishment of specifications, oversight of stability programs and the active management and documentation of data. The selected candidate will also work collaboratively with Quality Assurance to assess laboratory conformance with cGMPs, and with CMC Regulatory Affairs to author Module 3 sections of CTD regulatory submissions and written responses to regulatory authorities.
Primary Responsibilities
- Oversee the phase-appropriate analytical activity at contract manufacturers/service providers including analytical method development, qualification and validation for drug substance and drug product.
- Partner with stakeholders to 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.
- Establish workflows and procedures for analytical and quality control activities.
- Manage reference standards program, coordinate sourcing, ensure inventory, plan and execute testing and retesting activities, and manage shipments of reference standards.
- Author, review and approve various analytical reports in a timely manner 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.
- Sometimes represent analytical function in CMC teams and project meetings, and work closely with cross-functional teams to meet project timelines and goals.
- Review/approve controlled cGMP documents, e.g., analytical methods and associated validation protocols/reports, specifications, stability protocols, change controls, LIRs, etc.
- 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.
Qualifications and Requirements
- Ph.D. with 8+ years of experience or BS or MS in chemistry or related discipline with 10-15 years of industry experience in an analytical chemistry setting.
- Good understanding and knowledge of pharmaceutical analytical methods and related issues.
- Experience with analytical development of small molecules and drug product oral dosage forms from preclinical to late-stage clinical development.
- Experience managing drug substance and drug product service providers in analytical matters.
- Extensive knowledge of GLP and cGMP requirements, appropriate regulatory guidance and current industry practices for analytical development.
- Experience in writing CMC sections for Regulatory submissions (IND experience required; NDA experience highly desirable).
- Excellent computer skills (e.g., Microsoft Office, Excel, Project).
- Ability to effectively manage multiple priorities and projects.
- Be able to work (hybrid) from Thousand Oaks or San Francisco, CA offices.
