Director of CMC

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 a.bero@proclinical.com.

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.

INDSCIC