The Role:

Reporting to the Associate Director, Analytical Sciences, the Senior Scientist, Analytical Sciences, has responsibility for the analytical aspects of drug product development and manufacturing activities across the relevant Nuvalent CRO and CDMOs. The candidate will interface with the program’s Quality Control, Drug Product, Quality Assurance, CMC Project Manager and Regulatory CMC functional representatives. Responsibilities include ensuring that drug product analytical support is timely, high quality, and consistent with the Phase-Appropriate strategy outlined by the project team and CMC Team.

The candidate will support analytical activities for a clinical small molecule oncology program. This role would entail internal and external facing responsibilities as a member of the analytical sciences group on the cross-functional CMC team and through analytical leadership of key external CRO/CDMO relationships.

The successful candidate needs to demonstrate a proven track record of working with CROs/CDMOs to support drug product development through the delivery of high-quality analytical methods, process support, and stability studies. The ability to thrive in a virtual environment in support of developing and delivering drug product for fast-paced clinical development programs will be critical. In addition, using strong technical analytical experience and effective knowledge of industry regulatory guidance, the candidate will support phase appropriate drug product development efforts, dissolution development, contribute to the analytical strategy and assist in the authoring and reviewing technical regulatory submission documents.

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.

Competencies Include:

• 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.
• Excellent communication and multi-tasking skills
• Strong interpersonal skills and experience contributing to productive teams and fostering cross functional relationships

Qualifications:

• 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