Unity Biotechnology is seeking an exceptional and highly motivated individual to lead the Analytical Development group. Reporting to the Vice President of Technical Operations, the individual will lead all analytic development activities across a dynamic development space, including CMO leadership and in-house development of phase appropriate analytical methods to support Unity’s extensive portfolio. The successful candidate will be flexible, have strong leadership skills, be quality minded, and be well versed in small molecule analytical method development and validation for drug substances and drug products beyond solid oral dosage.
- Develop and optimize phase appropriate analytical test methods, with a focus on stability indicating HPLC methods, to support sterile liquid, suspension, and lyophilized formulations for parental, pulmonary, and ocular development programs
- Develop and optimize phase appropriate analytical in-process and release methods to support drug substance manufacturing, focusing on HPLC based methods
- Manage technology transfer and validation of analytical methods to support starting material, intermediate, drug substance and drug product testing at CMOs
- Working with members of Technical Operations and Quality Assurance, establish and justify specifications for drug substances, starting materials, intermediates and drug products
- Identify and characterize impurities and degradation products
- Oversee release testing and stability studies of drug substances and drug products at CMOs
- Trend in-process, release, and stability data using statistical methods
- Working closely with other senior members of the Technical Operations team, help to evaluate and select pharmaceutical development and manufacturing CMOs that are aligned with Unity’s development strategy.
- Project leadership and management of multiple drug product CMOs, including technology transfers and person-in-plant as part of outsourcing oversight.
- Serve as the Technical Operations group representative on Unity multidisciplinary project teams.
- Review and approve method protocols, method validations, and development reports for GMP activities.
- Authorship of regulatory documents (IND/CTA and NDA/MAA) as well as internal development reports.
- Ability to coordinate with internal and external quality control, quality assurance, and regulatory personnel to resolve technical issues or deviations.
- Up to 15% travel to domestic and foreign contractors for scientific project management and monitoring of critical project activities.