Scientist, Analytical Sciences / QC

The Role:
Reporting to the Associate Director, Analytical Sciences / QC, the Scientist, Analytical Sciences / QC 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, 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 Scientist, Analytical Sciences / QC will support analytical activities for a late-stage 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 (DP) for fast-paced clinical development programs will be critical. In addition, using strong technical analytical experience and an effective knowledge of industry regulatory guidance, the candidate will support late phase DP development efforts, dissolution development, contribute to the analytical strategy and assist in the authoring and review of technical regulatory submission documents. 

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 specifica-tion, and regulatory source documents
•    Support analytical aspects of RSM and drug substance development for a late phase analytical pro-gram.
•    Assist in global regulatory CMC activities through authoring and review of technical and submission documents
•    Technical analytical sciences experience
•    Knowledge of relevant industry guidance for US and Global products
•    Novel therapeutic pharmaceutical development
•    Small molecule analytical development and validation (method development / transfer / validation using chromatography (LC-UV, -MS; GC-HSS, -MS, -FID), PSD, KF, dissolution, etc.)
•    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.

Qualifications: 
•    BS or equivalent in chemistry or related discipline with 3-5years 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)