Senior Scientist, Chemical Development

Summary

Join Nuvalent, a dynamic early-stage company focused on developing cancer treatments, as a Senior Scientist in Chemical Development. Reporting to the Associate Director, you will be a technical expert responsible for drug substance development, from candidate nomination to commercialization. You will manage external CROs/CMOs, oversee process development and scale-up, and ensure drug substance supply meets clinical program needs. This role requires a proven track record in a virtual environment and a strong understanding of regulatory guidelines. Success in this position demands excellent organizational and interpersonal skills, along with independent decision-making capabilities. The position involves up to 20% domestic and international travel.

Requirements

• PhD in organic chemistry or chemical engineering with a minimum of 5 years of industry experience or Bachelors / Masters 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

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
• Manages external CROs/CMOs, as well as vendors
• Compare and contrast lab and manufacturing process information to provide insights
• Ensure that the drug substance development is compliant with both relevant regulations and regulatory commitments
• Author relevant regulatory documents

Preferred Qualifications

• Previous exposure to Process Performance Qualification is desirable
• Experience working in a drug substance manufacturing plant is highly desirable
• Experience with implementation of QbD strategies during drug substance development and Life-cycle management