Manager, Synthetic Chemistry Process Development
We are seeking a highly motivated and experienced individual to co-ordinate small molecule process development, scale-up, and process validation activities at CMOs
- Coordinate small molecule process development, optimization, scale-up, tech transfer, validation, and technical support for manufacturing at CMOs.
- Preparation of technology transfer packages to support technical transfer activities at CMOs.
- Leading/managing the DOE study to finalize the process and the process validation
- Developing/implementing strategies to reduce the COGS of final compounds and regulatory starting materials (RSM) while also maintaining a robust supply chain
- Author and approve validation protocols and reports
- Author SOP on process policy as part of a validation master program that is compliant with all current FDA guidance’s and expectations, including ICH Q8R2 regarding QbD and ICH Q9 and 10 regarding quality, risk management and continual improvement/lifecycle stage goals
- Oversight and administration of site master validation program.
- Support preparation of regulatory filings (including INDs, IMPDs, NDAs/BLAs, briefing packages, and other regulatory dossiers).
- Author and/or review department related technical reports, specifications, corrective/preventative actions, change controls, investigations, and deviations to ensure compliance with CGMPs and company standards
- PhD with 5+ years or related experience, MS with 10+ years of related experience, Bachelors with 15+ years of related experience. Degree in Chemistry, Chemical Engineering, or a related discipline.
- Significant experience in the areas of process development, process characterization, process validation and product life cycle management is required.
- Experience in preparation of CMC documents in support of global regulatory filings across development stages (e.g. IND to NDA/BLA)
- Experience working in a virtual organization and managing CMOs.