Nuvalent, Inc. · 1 month ago
Senior Scientist, Analytical Sciences
United States
Full-time
Remote
Senior Level
$140K/yr - $160K/yr
6+ years expNuvalent, Inc. is an early-stage company focused on developing selective medicines for cancer patients. The Senior Scientist, Analytical Sciences will lead analytical method development and validation for drug product development, ensuring high-quality support for clinical programs and managing relationships with CROs and CDMOs.
BiotechnologyLife ScienceTherapeutics
Responsibilities
Lead drug product analytical method development and method validation for a clinical development program
Author and review method development, method transfer, method validation, specification, justification of specification, and regulatory source documents
Oversee and manage CDMO counterparts through analytical method development as well as analytical routine activities to support drug product manufacturing (release and stability testing, batch record review)
Provide internal and external leadership through management of quality events such as deviations, OOS/OOT, investigations, CAPA, etc
Support the design of drug product stability studies, retest and shelf-life document strategy and execution
Support analytical aspects of RSM and drug substance development and phase appropriate method validation
Work within a cross-functional team to help design and execute control strategies in support of novel clinical therapeutics
Assist in global regulatory CMC activities through authoring and reviewing technical and submission documents
Integrated member of cross functional CMC team
Qualification
Required
6-8 years of experience in industry or CRO
BS or equivalent in chemistry or related discipline (3-5 years' experience with a PhD in chemistry or related discipline)
Hands-on experience in small molecule analytical methods and method validation (HPLC, GC, LC-MS, dissolution, KF, forced degradation, etc.)
Strong scientific writing experience with the ability to author and review relevant documents (methods, protocols, reports)
Proven track record of technical contributions in a virtual environment, including working with/leading CROs and CDMOs
Knowledge of relevant industry guidance for US and Global products and regulatory guidelines (FDA and EMA)
Knowledge of ICH guidance and pharmacopeias (USP, EP, JP, etc.)
Ability to solve analytical and QC technical challenges
Novel drug development analytical experience
Benefits
Medical, dental, and vision insurance
401(k) retirement savings plan
Generous paid time off (including a summer and winter company shutdown)
Company
Nuvalent, Inc.
Nuvalent is creating precisely targeted therapies for patients with cancer designed to overcome the limitations of existing therapies for clinically proven kinase targets.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.82BKey Investors
Bain Capital Life SciencesDeerfield
2026-06-09Acquired
2025-11-18Post Ipo Secondary· $500M
2024-09-16Post Ipo Equity· $575M
Leadership Team
James Porter
CEO
Alexandra Balcom
Chief Financial Officer
Recent News
Labiotech UG
2026-07-10
Morningstar.com
2026-07-06
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