Hybrid Director, Process Chemistry bei Ardelyx
Ardelyx · Waltham, Vereinigte Staaten Von Amerika · Hybrid
- Senior
- Optionales Büro in Waltham
Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA® (tenapanor) and XPHOZAH® (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL® (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada.
- Direct Drug Substance (DS) efforts, including process development as well as the manufacture of DS for clinical and commercial purposes
- Develop, manage, and drive the successful execution of phase-appropriate DS project plans; prepare RFPs and assist in selecting vendors
- Lead the preparation of the DS sections of various regulatory documents (IND, NDA, etc.)
- Effectively integrate DS activities with those of sister CMC functions, including Pharmaceutics, Analytical Development, Quality Assurance, and Regulatory Affairs
- Direct external technical staff as needed to ensure effective execution of activities and attainment of goals.
- Effectively and professionally represent the Process Chemistry function, and when needed the broader CMC function, on various cross-functional teams including internal project teams as well as external steering and operating teams with contract manufacturing and/or corporate partners
- Ph.D. in organic chemistry or related discipline with 12+ years of industry experience or equivalent experience
- Strong experience required in small molecule process development
- Experience supporting DS for different drug product types is desirable
- Experience working in close collaboration with technical, regulatory, quality, clinical, project management, and supply chain functions, in a cGMP operational environment
- Experience in leading and managing outsourced development and manufacturing efforts and associated operating budgets
- Experience in preparing and defending regulatory documents including briefing books for regulatory meetings, INDs, and NDAs
- Periodic travel to manufacturing and other partner sites is required (approximately 10-20 % of time).
