This leading cutting-edge Biotech is looking for a scientific chemical development leader who has experience in a fast paced environment overseeing early to late stage small molecule drug manufacturing and development.
- Manages collaborations with contract service providers on development and manufacturing activities, including but not limited to process chemistry development and refinement, production from lab scale through commercial scale, drug substance characterization.
- Identifies contract service providers
- Reviews, interprets, and approves process development reports and ensure that these meet the current standards to support regulatory filing.
- Identifies opportunities to optimize the manufacturing processes, focusing on patient safety/efficacy and process economics.
- Supports the drug substance regulatory process by writing and reviewing sections of the CTD for IND, CTA and NDA submissions.
- Collaborate with project teams to meet project company objectives and timelines.
- Regularly communicates progress of projects to the department head and as required senior management
- Ph.D. in Organic Chemistry with 10+ years of drug substance development related experience in pharmaceutical/biotech industry.
- Knowledge of drug substance CDMO landscape, ability to contribute to the identification and selection of CDMO partners.
- A deep understanding of ICH and related drug substance related guidance to support the various development phases to filing and launch.
- Experience in late phase development activities, e.g. scale up and manufacture of drug substance for use in pivotal clinical trials, registration stability studies, and process validation.
- Experience authoring Initial New Drug Applications (IND), New Drug Applications (NDA) and responding to CMC questions from FDA/international regulatory authorities.