Sr Director CMC

Proclinical; Trenton (NJ); Sur place; USD 230 000 - 275 000; Plein temps

Résumé du poste

A leading biotech consulting firm is seeking a Senior CMC leader for their Trenton, NJ office. This critical role involves managing end-to-end strategy for small-molecule development programs, advancing them into clinical trials. Ideal candidates will have a PhD in Organic Chemistry and over 12 years of CMC experience in pharma or biotech. Responsibilities include leading process chemistry, external manufacturing, and regulatory CMC activities. Competitive salary range of $230,000 to $275,000 annually.

Qualifications

• 12+ years of experience in CMC or process chemistry roles in pharma/biotech.
• Expertise in managing external manufacturing and regulatory CMC activities.
• Ability to define and execute CMC strategy effectively.

Responsabilités

• Lead process chemistry, external manufacturing, and regulatory CMC activities.
• Define and execute CMC strategy across API and drug product development.
• Manage relationships with external partners for quality and timelines.
• Represent CMC in cross-functional and regulatory interactions.

Connaissances

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

Formation

PhD in Organic Chemistry or related discipline

Description du poste

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 [e-mail]

Apply

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