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Job type: Permanent

Discipline: CMC

Location: United States

Sr Director CMC - Permanent - New Jersey

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

��Ƶ 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 will be:

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:

$265,000 to $275,000 per annum.

If you are having difficulty in applying or if you have any questions, please contact Alex Bill at a.bill@proclinical.com

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.

��Ƶ is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. ��Ƶ is acting as an Employment Agency in relation to this vacancy.

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