Ardelyx is a publicly traded biotech company focused on improving the lives of patients by developing and commercializing first-in-class targeted therapies that advance patient care. Using our discovery model, Ardelyx scientists have characterized new biological mechanisms and pathways that have enabled us to develop a pipeline of drug candidates to manage complications related to kidney and cardiovascular diseases. Our lead candidate, tenapanor, is a first-in-class small molecule therapy for the treatment of hyperphosphatemia in adult patients with chronic kidney disease on dialysis. If approved, tenapanor could completely change the treatment paradigm in a disease state with significant unmet need. We are advancing the build of our commercial organization to be prepared for launch of tenapanor in mid-2021.
Director of Process Chemistry
Purpose of the role:
The Director of Process Chemistry is an accomplished, scientist, leader, and manager. This is a leadership role, requiring sophisticated technical knowledge, and communication skills to communicate experimental ideas, interpret data and to assist the team in the development and commercialization of first-in-class, medicines. The incumbent will contribute directly to the regulatory strategy and writing of technical sections of IND’s and NDA’s as appropriate and must be willing to “roll up his/her sleeves” when necessary, to meet corporate goals.
- Plan and execute development strategies for the synthesis of active pharmaceutical ingredients
- Recruit and Lead the process chemistry group to design, demonstrate, optimize, and document chemical processes for small molecule drug candidates
- Select outsourcing partners, and help transfer and troubleshoot chemical processes to meet project goals and timelines
- Independently interpret data from internal efforts as well as our outsourcing partners and present results and outcomes to diverse audiences, including senior management
- Collaborate with all research groups to design project timelines and generate materials in support of planned IND’s, and Clinical trials. This includes planning and execution to deliver toxicology supplies, reference standards, impurity markers, and radiolabeled API as needed
- Collaborate with Formulations, Analytical and Supply Chain groups to design project timelines and generate materials in support of formulation development, clinical trials, and commercialization
- Assist with troubleshooting efforts in the commercial stage of projects, as well as, process scale-up and site stransfers
- Master’s or PhD degree in Chemistry and 15+ years relevant experience in modern synthetic organic chemistry
- Proficiency in synthetic organic chemistry
- Creative and adaptive problem solving; strong attention to detail in verbal and written communications
- Ability to thrive in a multi-tasking and complex environment with limited resources and have flexibility to adapt to changing demands or priorities based on corporate goals
As a member of the Ardelyx team, you will play a key role in developing and bringing to market first-in-class medicines to better the lives of underserved patients. It’s the patients in need that motivate and inspire us to be relentless and work hard every day. They push us to maintain a clear focus on scientific and clinical integrity with a commitment to medical innovation so that we can deliver exceptional medicines. We are different for good.
Ardelyx, Inc. is an Equal Opportunity Employer