Director of Process Chemistry

Ardelyx

Fremont, CA, US
  • Job Type: Full-Time
  • Function: Clinical Research
  • Post Date: 02/07/2021
  • Website: ardelyx.com
  • Company Address: 34175 Ardenwood Blvd., Fremont, CA, 94555

About Ardelyx

Ardelyx is focused on enhancing the way people with kidney and cardiovascular diseases are treated by developing innovative first-in-class medicines.

Job Description

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.

Position Responsibilities:

    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

Position Requirements:

    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

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.