Associate Director, Process Chemistry (CMC)

United States·Walthamexecutive

OtherDirector

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Quick Summary

Overview

Key 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.

Requirements Summary

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.

Technical Tools

project-management

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 $183,000 - $223,000 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.