Leading Analytical Scientist for Oncology Drug Development

3 days ago


Cambridge, Massachusetts, United States Lifelancer Full time

Job Overview:

Nuvalent is seeking an experienced Associate Director, Analytical Sciences to lead the strategic analytical aspects of drug substance and drug product development and manufacturing activities.

The ideal candidate will have a strong understanding of cGMP/ICH regulations and USP Guidelines, with expertise in late-phase small-molecule drug substance and drug product analytical support.

As a key member of the technical operations team, you will drive analytical strategy for late-stage oncology programs, ensuring compliance with regulatory requirements and delivering high-quality results.

About Nuvalent:

Nuvalent is a biotech company focused on developing selective medicines designed to address the needs of patients with cancer. Our team includes experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building.

About the Role:

You will be responsible for defining and executing analytical strategies, ensuring method optimization and ICH method validations, and participating in the definition of specifications for late-phase development candidates.

Additionally, you will author and review analytical-relevant regulatory submission documents, participate in investigation teams, and contribute to the build-out of Nuvalent's commercial analytical function.

Key Responsibilities:

Develop and execute analytical strategies for late-stage development candidatesEvaluate and optimize methods for drug substance and drug product analysisParticipate in the definition and justification of late-phase-appropriate specificationsAuthor and review analytical-relevant regulatory submission documentsCollaborate with cross-functional teams to deliver high-quality results

Requirements:

Bachelor's degree in chemistry or related field, or equivalent experience10-15 years of relevant industry experience, or PhD with 3-5 years of industry experienceStrong understanding of cGMP/ICH regulations and USP GuidelinesExpertise in late-phase small-molecule drug substance and drug product analytical supportExcellent written and interpersonal communication skillsAble to work independently and as part of a team

Estimated Salary: $150,000 - $200,000 per year

Location: Remote, USA

Contact Information: Apply through Lifelancer platform (https://lifelancer.com/jobs/view/d44d414a7131dfd98989e9b718eb230a)



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