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Job type: Permanent

Discipline: Analytical Chemistry, Biochemistry, Medicinal Chemistry

Location: United States

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

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