Associate Director, Analytical Sciences / QC
With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building.
In this newly created role, the Associate Director, Analytical Sciences Quality Control will join the Technical Operations team, leading the Quality Control unit within the Analytical Sciences group. This position will establish best practices, refine QC SOPs and workflows within the Analytical Sciences group, and ensure the quality and consistency of Nuvalent products. As a part of Nuvalent’s cross-functional CMC teams, the role will support small molecule drug candidate nomination through development and into commercialization. The successful candidate needs to demonstrate a proven track record of working in a virtual drug development environment with CROs/CMOs in support of developing and delivering products for fast-paced clinical development programs. Using strategic thinking, strong analytical and QC experience, and a commanding knowledge of industry regulatory guidance, the candidate will support product development efforts through the review, tracking, and trending of product data, ensuring phase appropriate method validations, supporting of specification strategy, defining and managing stability programs, and strategic shelf-life planning.
Reporting to the Head of Analytical Sciences, the Associate Director will lead the QC aspects of Nuvalent’s manufacturing activities and product release in partnership across the relevant Nuvalent CRO and CDMO for all programs. The role will include close collaboration with Nuvalent technical analytical scientists, Quality Assurance, and Regulatory CMC functional representatives. Responsibilities include tracking and trending of product testing data through the establishment of a robust and accessible database. In addition, the role will ensure data generated on Nuvalent products are well documented, of high quality, appropriately and consistently reported and aligned with the phase-appropriate strategy outlined by the project CMC Teams.
The successful candidate will drive value through the following areas/interactions:
- Define and execute QC strategy for Nuvalent development candidates
- Establish and maintain a robust and accessible internal database to track, trend, and manipulate Nuvalent product data.
- Lead analytical QC aspects of CRO/CDMO relationships including analytical method validation/transfer, data review, participation in quality events (deviations, OOS/OOT investigations, CAPA, etc.)
- Lead phase-appropriate retest and shelf-life strategy and execution for Nuvalent products
- Perform and/or oversee QC review of production, release, and stability data for completeness, accuracy, and consistency with specifications as applicable.
- Collaborate on design and execution of phase appropriate stability studies
- Contribute to defining phase-appropriate SM, Intermediate, DS, and DP specifications.
- Track and Trend analytical results as part of product and method life-cycle management
- Review relevant regulatory submission documents
- Author and review relevant change controls and SOPs.
- A strong understanding and knowledge of cGMP/ICH regulations and USP Guidelines with the ability to apply them to analytical DS and DP development and manufacturing is required
- Excellent attention to detail and ability to complete efficient and detailed technical data review
- Experience in pharmaceutical drug development as a member of a cross-functional/CMC team
- Experience using statistical tools to track and trend data (e.g. JMP, Excel, SLIM)
- Ability to perform statistical manipulation of pharmaceutical product data to support specification and shelf-life strategies
- In-depth experience with clinical and registration stability design, phase-appropriate analytical method validations, specification setting strategy, and shelf-life strategy
- Excellent organization, communication, and multi-tasking skills
- Exceptional interpersonal skills and experience contributing to productive teams and fostering cross functional relationships
- Strong desire to contribute as a member of an engaged and collaborative CMC team
- BS or equivalent in chemistry or related discipline with 10-15 years of relevant industry experience
- PhD in chemistry or related discipline with a minimum of 3-5 years of industry experience
- Novel drug development QC experience
- Proven track record solving analytical and QC challenges with a focus on small molecules
- Mastery of current ICH guidelines and related industry guidelines and practices
- Technical leadership experience with CROs and CDMOs and as a people manager
- Ability to author and review relevant documentation (methods, protocols, reports) as well as regulatory sections
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.
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