Analytical Scientist

Summary

Join Nuvalent, a dynamic early-stage company focused on developing selective cancer medicines, as a Scientist in Analytical Sciences/QC. Reporting to the Associate Director, you will play a crucial role in the analytical aspects of drug product development and manufacturing. This involves collaborating with internal and external teams, including CROs and CDMOs, to ensure timely and high-quality analytical support for a late-stage oncology program. You will lead analytical development and manufacturing activities, manage quality events, and contribute to regulatory submissions. The ideal candidate possesses strong technical expertise, experience with CRO/CDMOs, and excellent communication skills. This role offers the opportunity to contribute significantly to the advancement of novel therapeutics.

Requirements

• BS or equivalent in chemistry or related discipline with 3-5 years of relevant industry experience
• PhD in chemistry or related discipline with a minimum of 1-3 years of industry experience
• Novel drug development analytical experience
• Proven track record of technical contributions in a virtual environment, including working with/leading CROs and CDMOs
• Ability to solve analytical and QC challenges
• Excellent organization and multi-tasking skills
• Strong interpersonal skills and experience contributing to productive teams and fostering cross-functional relationships
• Ability to author and review relevant documents (methods, protocols, reports)

Responsibilities

• Manage CDMO counterparts through analytical aspects of pre-process validation (pre-PPQ) and PPQ activities for late phase drug candidate
• Lead drug product analytical development and manufacturing activities across a global network of CDMOs (method validations, batch review, stability studies, etc.)
• Provide internal and external leadership through management of quality events such as deviations, OOS/OOT, investigations, CAPA, etc
• Support retest and shelf-life document strategy and execution
• Work within a cross-functional team to help design and execute control strategies in support of late phase novel therapeutics
• Author and review method development, method validation, specification, justification of specification, and regulatory source documents
• Support analytical aspects of RSM and drug substance development for a late phase analytical program
• Assist in global regulatory CMC activities through authoring and review of technical and submission documents

Preferred Qualifications

• Excellent organization and multi-tasking skills and Ability to drive and deliver multiple projects within project scope and timelines
• Relationship Building – Builds productive working relationships and effectively communicates across a diverse spectrum of people
• Ability to think critically with attention to detail
• Adaptability/Flexibility – The ability to adapt to working effectively within a variety of situations; adapts enthusiastically to organizational change and to changes in job demands