Proclinical Staffing ยท 2 days ago
Sr Director CMC
Trenton, NJ
Full-time
Onsite
Director/Executive
$265K/yr - $275K/yr
12+ years expProclinical Staffing 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. 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.
Staffing & Recruiting
Hiring Manager
Alex Bill
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
Qualification
Required
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
Company
Proclinical Staffing
At Proclinical Staffing, our life science recruitment services support our partners with permanent and contract vacancies by connecting them with specialist talent across the globe.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase