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Proclinical Staffing

Sr Director CMC

Proclinical Staffing, Trenton, New Jersey, us, 08628

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This range is provided by Proclinical Staffing. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range $230,000.00/yr - $275,000.00/yr

Principal Consultant at Proclinical Staffing (Sr) Director CMC - Permanent - New Jersey

Are you ready to lead cutting‑edge projects that accelerate clinical breakthroughs in biotech?

Proclinical is seeking a senior CMC leader to own end‑to‑end strategy and execution for small‑molecule development programs advancing from discovery into the clinic.

Primary Responsibilities This role will lead process chemistry, external manufacturing, and regulatory CMC activities while partnering closely with R&D and leadership in a fast‑growing, lean organization.

Skills & Requirements

PhD in Organic Chemistry or related discipline.

12+ years in pharma/biotech CMC or process chemistry roles.

Strong hands‑on experience with small‑molecule API and drug product development.

Demonstrated success advancing programs into the clinic.

Comfortable operating in startup or resource‑constrained environments.

Proven ability to manage multiple external partners and aggressive timelines.

The Sr Director CMC's responsibilities

Define and execute CMC strategy across API and drug product development.

Lead process development, scale‑up, solid form work, and tech transfer via CROs/CDMOs.

Manage and hold external manufacturing partners accountable for quality, cost, and timelines.

Review and approve batch documentation and manufacturing records.

Partner on CMC‑related IP strategy and regulatory submissions (IND‑enabling through early clinical).

Represent CMC in cross‑functional and regulatory interactions.

Compensation

$230,000 to $275,000 per annum.

Contact If you are having difficulty in applying or if you have any questions, please contact

Alex Bill

at

a.bill@proclinical.com

Apply If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

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