Associate Director, Process Chemistry (CMC)
Ardelyx, Waltham, MA, United States
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, 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 (Analytical, QA, Regulatory, Clinical Supply) and 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 experience within CMC/process chemistry.
Proven track record in developing scalable, safe, and efficient synthetic processes within cGMP operational environments; small‑molecule experience strongly preferred.
Experience collaborating closely with technical, regulatory, quality, clinical, project management, and supply‑chain functions in a cGMP operational environment.
Experience leading and managing outsourced development and manufacturing efforts and associated operating budgets.
Experience 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.
Periodic travel to manufacturing and partner sites required (approximately 10‑20 % of time).
Compensation and Benefits The anticipated annualized base pay range for this full‑time position is $183,000 - $223,000. Ardelyx uses industry data to ensure compensation is competitive and aligned with peers. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements. Benefits include 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, an annual winter holiday shutdown, and at least 11 paid holidays.
EEO Statement Ardelyx is an equal opportunity employer.
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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 (Analytical, QA, Regulatory, Clinical Supply) and 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 experience within CMC/process chemistry.
Proven track record in developing scalable, safe, and efficient synthetic processes within cGMP operational environments; small‑molecule experience strongly preferred.
Experience collaborating closely with technical, regulatory, quality, clinical, project management, and supply‑chain functions in a cGMP operational environment.
Experience leading and managing outsourced development and manufacturing efforts and associated operating budgets.
Experience 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.
Periodic travel to manufacturing and partner sites required (approximately 10‑20 % of time).
Compensation and Benefits The anticipated annualized base pay range for this full‑time position is $183,000 - $223,000. Ardelyx uses industry data to ensure compensation is competitive and aligned with peers. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements. Benefits include 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, an annual winter holiday shutdown, and at least 11 paid holidays.
EEO Statement Ardelyx is an equal opportunity employer.
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