Associate Director/ Principal Scientist, Analytical Development

Company: Nuvalent
Location: Cambridge
Posted on: February 19, 2021

Job Description:

Associate Director/ Principal Scientist, Analytical DevelopmentUS-MA-CambridgeJob ID: 2Type: Regular Full-Time# of Openings: 1Category: Research & DevelopmentNuvalentOverview Associate Director/Principal Scientist, Analytical Development With deep expertise in chemistry, Nuvalent is creating selective medicines to address the needs of patients with cancer. Nuvalent is an exciting early stage company and brings together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. Nuvalent is funded by Deerfield Management. Job Summary: The Associate Director/Principal Scientist, Analytical Development will be a primary contributor in the Pharmaceutical Development group and will serve a key role in structuring and executing drug development strategies at Nuvalent . The candidate should be a drug substance and drug product analytical testing subject matter expert, who is a strategic thinker with a proven track record of successes. Strong project leadership skills are a must to lead external R&D. The Principal Scientist supports the development, validation, and transfer of analytical methodologies for incoming raw materials, in-process, drug substance, drug product release and stability testing at external research and manufacturing organizations. This person has expertise in pharmaceutical analytical chemistry as well as experience in authoring relevant Quality sections of regulatory submissions. Responsibilities Opportunity and Responsibilities:

• Be a part of a team that sets development strategies and oversees drug substance and drug product process design, optimization, scale-up, and manufacturing in support of early phase clinical development
• Provide technical leadership (i.e., method development, trouble shooting, investigations, new technology implementation, etc.) as part of a development team to bring complex small molecules quickly and efficiently into the clinic
• Serve as the internal SME to oversee and provide critical review of externally generated method validations, testing, and stability programs
• Interface with cross-functional teams (i.e. Medicinal Chemistry, Drug Metabolism and Pharmacokinetics, Toxicology, Quality Assurance, Pharmaceutical Development, Project Management and Regulatory Affairs) to influence the lifecycle of projects
• Author and review relevant sections of regulatory filings
• Manage small external team to address technical issues encountered in the above areas of focus Qualifications Minimum Requirements
  • Ph.D. or M.S. in analytical chemistry, organic chemistry, or related discipline
  • 7+ years of relevant experience in analytical development preferably supporting early phase drug development
  • Knowledge and understanding of current ICH guidelines, GLP/GMP guidelines, and related industry practices
  • Hands-on experiences in analytical method development using HPLC, HPLC-MS, GC, KF, and dissolution
  • Working experience and knowledge of regulatory submissions (IND, IMPD and/or NDA)
  • Excellent scientific and business communication skills (verbal, written and technical), strong interpersonal/collaboration skills and planning skills.
  • Ability to think critically with strong attention to detail
  • Ability to work independently to determine appropriate resources to overcome challenges Nuvalent provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law. PM18 #LI-DNI
    
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Keywords: Nuvalent, Cambridge , Associate Director/ Principal Scientist, Analytical Development, Executive , Cambridge, Massachusetts