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About the Role
Latigo Biotherapeutics is seeking an Associate Director/Principal Scientist, CMC Analytical Chemistry to manage preclinical to clinical analytical development activities and oversee testing and release of drug substance and drug product at contract manufacturers. The role is responsible for developing, validating, and implementing QC methods for various materials, managing reference standards, establishing specifications, overseeing stability programs, and actively managing data. The candidate will collaborate with Quality Assurance and CMC Regulatory Affairs for cGMP compliance and regulatory submissions.
Responsibilities
- Oversee phase-appropriate analytical activity at contract manufacturers/service providers, including 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, providing guidance for shelf-life and expiry dating.
- Establish workflows and procedures for analytical and quality control activities.
- Manage the reference standards program, including sourcing, inventory, testing, retesting, and shipments.
- Author, review, and approve analytical reports to support drug substance/product development, manufacture, and regulatory filings.
- Support regulatory submissions by drafting and reviewing analytical sections of INDs, IMPDs, and NDAs, ensuring compliance with current regulatory requirements.
- Represent the analytical function in CMC teams and project meetings, collaborating with cross-functional teams to meet project timelines and goals.
- Review and approve controlled cGMP documents, such as analytical methods, validation protocols/reports, specifications, stability protocols, change controls, and LIRs.
- Manage and perform QC review/approval of analytical test data for IPC testing, drug substance/product batch release, and stability data.
- Manage and review deviation events and OOS/OOT investigations in coordination with CMC counterparts, QA, and regulatory team members.
- Contribute to building CMC infrastructure and company culture.
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.
Skills
- Analytical Chemistry
- Method Development
- Method Validation
- Quality Control
- Drug Substance
- Drug Product
- Small Molecules
- Oral Dosage Forms
- GLP
- cGMP
- Regulatory Submissions
- IND
- NDA
- Microsoft Office
- Excel
- Project Management
Location
- San Francisco, CA
- Thousand Oaks, CA
Work Type
- Full Time
- Hybrid
Experience Level
- Associate Director
- Principal Scientist
- 8+ years of experience
- 10-15 years of experience
Education Level
- Ph.D.
- BS
- MS
About the Company
- Latigo Biotherapeutics is a public, clinical-stage biotechnology company discovering and developing the next generation of non-opioid medicines for pain and pain-related syndromes to transform the lives of patients.
- Latigo has a robust pipeline, is well-funded by blue chip investors, and has a highly successful management team and Board of Directors.
- The company was founded in 2019 and is based in Thousand Oaks, CA.
- We are science-based, data-driven, patient-focused, and forward-thinking.