What are the responsibilities and job description for the Sr Director CMC position 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 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:
- $230,000 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.
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Salary : $230,000 - $275,000