Associate Director, Process Chemistry

The Role:

Reporting to the Director, Chemical Development, the Associate Director, Process Chemistry will serve as a technical subject matter expert responsible for drug substance development from development candidate nomination through commercialization.  The successful candidate needs to demonstrate a proven track record of working in a virtual environment with CDMOs to deliver manufacturing processes that can be scaled to deliver drug substance for fast-paced clinical development programs.  Using strategic thinking, the Associate Director, Process Chemistry must be able to develop and defend a process design space.

This individual will oversee drug substance process development, scale up, and manufacturing activities related to Nuvalent’s development and clinical programs.  The main directive will be to ensure that drug substance supply is not rate limiting to any program’s overall development, while ensuring that the material delivered is of high quality and economically sound. 

Responsibilities:

• Solve technical issues relating to external drug substance manufacturing by providing leadership within the Chemical Development group.
• Responsible for drug substance process design, optimization, scale-up, technology transfer, validation, and maintaining the lifecycle of the product.
• Ensure relevant data is captured in reports provided by external CROs/CMOs.
• Compare and contrast lab and manufacturing process information to provide direction.
• Ensure that the drug substance development is compliant with both relevant regulations and regulatory commitments.
• Author relevant regulatory documents.
• A strong understanding and knowledge of CGMP/ICH regulations and an ability to apply them to drug substance development and manufacturing.

Competencies:

• Excellent organization and multi-tasking skills.
• Exceptional interpersonal skills and experience building productive teams and cross functional relationships.
• Capable of being an independent decision maker, and comfortable with accountability.

 Qualifications:

• PhD in organic chemistry or chemical engineering with a minimum of 5 years of industry experience or MSc and 10 years of industry experience in a chemical development role.
• Proven track record solving chemical and manufacturing challenges at all stages of development.
• Mastery of current ICH guidelines and related industry guidelines and practices.
• Management experience with CROs and CDMOs and working in an outsourced regulated environment.
• Ability to author and review relevant process development reports as well as regulatory sections.
• Previous exposure to Process Performance Qualification is desirable.
• Experience working in a drug substance manufacturing plant is required.
• Experience with implementation of QbD strategies during drug substance development and Life-cycle management.
• 20% travel is expected, both domestic and international.