Director of CMC

Up to US$0.00 per annum + Highly Competitive Salary
  1. Permanent
  2. Analytical Chemistry, Biochemistry, Medicinal Chemistry
  3. United States
Princeton, USA
Posting date: 28 Mar 2024

Director of CMC - Permanent - Princeton, NJ

Proclinical is seeking a talented and motivated Director of CMC for a leading biotechnology company located in Princeton, NJ.

Primary Responsibilities

The successful candidate will play a crucial role in developing our overall API strategy, overseeing development activities, and managing CDMO partners. This role is integral to our mission of building a world-class computational drug discovery platform, merging physics-based and statistical modeling, and discovering breakthrough medicines.

Skills & Requirements:

  • A PhD in Organic Chemistry or related fields, with a minimum of 8 years of experience working in a pharmaceutical or biotech company.
  • Experience in both drug substances and drug products.
  • Demonstrated accomplishments in progressing projects into clinical development.
  • Highly efficient in managing multiple projects under timeline constraints.
  • Skilled in leading multidisciplinary teams to achieve company goals.
  • Ability to anticipate challenges and proactively devise mitigation plans.
  • Excellent presentation and communication skills.
  • Experience in preformulation API development is desirable.

The Associate Director, Access & Reimbursement - Oncology will:

  • Develop overall API strategy, timelines, budgets, risks & mitigations plans of all process development, starting materials, and manufacturing campaigns.
  • Oversee development activities including scale up, form screening and technology transfer at CRO and CDMO partners, ensuring efficiency, safety, and cost-effectiveness.
  • Manage CDMO partners to ensure quality and timely delivery of API.
  • Review and approve batch documents for drug substance manufacturing.
  • Interact with external patent counsel in helping to draft patent applications for any new chemistry.
  • Contribute to the authorship of CMC regulatory documents.

If you are having difficulty in applying or if you have any questions, please contact Alexander Bero at +1 512-270-2291 or

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.