Backed by 5AM Ventures.
About the role
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.
What they're looking for
- 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
More about this role
Job: Associate Director/Principal Scientist, CMC Analytical Chemistry
Position type: Full Time
Organization Overview
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.
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...
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