Senior Manager, Formulation Scientist

Summary

Join Nuvalent, a leading biopharmaceutical company focused on developing innovative cancer treatments, as a Senior Manager, Formulation Sciences. Reporting to the Associate Director, you will play a pivotal role in drug product development and manufacturing, working closely with CDMOs. Your responsibilities include formulation design, optimization, and scale-up, as well as overseeing external manufacturing and ensuring regulatory compliance. You will also support discovery programs and contribute to regulatory filings. This role requires a strong technical background and experience in a virtual environment. Success in this position demands excellent organizational skills, problem-solving abilities, and effective cross-functional collaboration.

Requirements

• PhD in pharmaceutics, pharmaceutical sciences, chemical engineering or related field with a minimum of 3+ years or MS with 6+ years /BS with 10+ years of industry experience
• Proven track record on phase appropriate drug product formulation development (i.e., IND-Enabling like amorphous solid dispersion using spray drying) and solving formulation and manufacturing challenges
• A good understanding and knowledge of CGMP/ICH regulations and an ability to apply them to drug product development and manufacturing is required
• Manage the outsourcing (formulation/process development and manufacturing) activities at CDMO sites to meet CMC goals
• Mastery of current ICH guidelines and related industry guidelines and practices
• Ability to author and review relevant development reports as well as regulatory dossiers
• 20% travel (domestic and international) is expected

Responsibilities

• Responsible for drug product formulation and process design, optimization, scale-up, and technology transfer
• Oversight of external drug product manufacturing by providing guidance to CDMOs
• Support discovery programs as they seek suitable formulations for preclinical studies
• Ensure relevant data is captured in reports provided by external CROs/CMOs
• Identify key knowledge gaps and execute plans to ensure our process understanding is commensurate with a given program’s stage of clinical development
• Ensure that the formulation and process development is compliant with both relevant regulations and regulatory commitments
• Draft tech transfer packages, review and provide feedback on batch records and development reports, manage internal timeline, and monitor development and manufacturing progress
• Efficiently work cross-functionally with project teams including QA, analytical, drug substance development, and supply chain
• Support authoring of the relevant technical sections of regulatory filings
• Effectively manage drug product development activities working in a virtual environment

Preferred Qualifications

• Experience with the implementation of QbD strategies and DoE approach during development is a plus
• Experience with pediatric formulation development i.e. minitablets is a plus