Associate Director, Process Chemistry (CMC)
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Job Location:
Waltham, MA - USA
Monthly Salary:
$ 183000 - 223000
Posted on:
5 days ago
Vacancies:
1 Vacancy
Department:
Job Summary
Description
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.
Position Summary:
We are seeking an experienced CMC-focused process chemist to lead early-phase small-molecule Drug Substance (DS) development from route selection through Phase 2 clinical manufacturing.
The ideal candidate will be a hands-on technical leader with deep expertise in process chemistry within a CMC organization who has directly supported IND-enabling through early clinical supply and thrives in a fast-paced build and deliver environment.
This role will be a key driver in DS development strategy and execution working closely with CMC partners and external CMOs to ensure rapid high-quality clinical supply delivery with phase appropriate rigor.
This is a hybrid role (2-3 days in office) at our Waltham MA headquarters.
Responsibilities:
- Lead early-phase DS process development (CMC) from route selection through clinical manufacturing.
- Provide hands-on technical oversight of route design optimization and scale-up in a CMO-based model.
- Drive fit-for-purpose process development strategies balancing speed to clinic robustness safety and scalability.
- Own DS program execution including development plans and timelines
- CMO selection RFP development and technical evaluation
- Oversight of tech transfer scale-up and GMP manufacturing
Contribute to and review CMC sections of regulatory filings and support health authority interactions. Serve as the CMC process chemistry lead on cross-functional teams (e.g. Analytical QA Regulatory Clinical Supply) Act as the technical point of accountability for external partners (CMOs) ensuring delivery against scope timeline and quality expectations.
Qualifications:
- Ph.D. in organic chemistry or related discipline with 8 years of pharmaceutical/biotech industry within CMC/process chemistry
- Proven track record in developing scalable safe and efficient synthetic processes within a cGMP operational environment. Experience with small molecule strongly preferred.
- 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
- Demonstrated track record of setting priorities meeting timelines and motivating others
- Excellent communication skills and the ability to shape frame and present to diverse internal and external audiences are required
- Periodic travel to manufacturing and other partner sites is required (approximately 10-20 % of time)
The anticipated annualized base pay range for this full-time position is $183000 - $223000 Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors including years of relevant experience training qualifications and internal equity. The compensation package may also include an annual bonus target and equity awards subject to eligibility and other requirements.
Ardelyx also offers a robust benefits package to employees including a 401(k) plan with generous employer match 12 weeks of paid parental leave up to 12 weeks of living organ and bone marrow leave equity incentive plans health plans (medical prescription drug dental and vision) life insurance and disability flexible time off annual Winter Holiday shut down and at least 11 paid holidays.
Ardelyx is an equal opportunity employer.
Required Experience:
Director
About Company
From discovery through commercialisation, all of us at Ardelyx are driven to advance targeted therapies where significant medical needs persist.
