The Company:
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.
The Role:
The Associate Director in Analytical Sciences will join the Technical Operations Team, acting as a technical subject matter expert (SME) accountable for Analytical Development and Quality Control as part of cross-functional CMC teams supporting candidate nomination through development and commercialization. The successful candidate needs to demonstrate a proven track record of working in a virtual drug development environment with CROs/CMOs to deliver analytical methods, characterization data, and stability studies in support of developing and delivering drug substance (DS) and drug product (DP) for fast-paced clinical development programs. Using strategic thinking, strong technical analytical experience, and an effective knowledge of industry regulatory guidance, the candidate will support DS and DP development efforts, drive specification strategy, define and manage stability programs, and contribute to the authoring and review of regulatory submission documents.
Reporting to the Head of Analytical Sciences the Associate Director will lead the analytical aspects of drug substance and drug product development and manufacturing activities across the relevant Nuvalent CRO and CDMO for given products. The role will include interfacing with the Drug Substance, Drug Product, Quality Assurance, and Regulatory CMC functional representatives on those programs to which they contribute. Responsibilities include ensuring that drug substance and drug product analytical support are timely, high quality, and consistent with the Phase-Appropriate strategy outlined by the project team and CMC Team.
The successful candidate will drive value through the following areas/interactions:
Responsibilities:
- Help define and execute on analytical development and QC strategy for Nuvalent development candidates
- Lead analytical aspects of CRO/CDMO relationships including technical activities, managing timelines/deliverables, input on relevant work orders, and maintaining resource planning.
- Take responsibility for API and Drug Product analytical method development and phase-appropriate validation
- Technical review of documents for analytical development, characterization, release, and stability. QC review for completeness, accuracy, and consistency with specifications as applicable.
- Design and execution of phase appropriate stability studies
- Leadership of shelf-life extension strategy for various Nuvalent Products
- Contribute to the analytical/QC technical aspects on a cross-functional CMC team
- Participate in the strategic definition and justification of phase-appropriate SM, Intermediate, DS, and DP specifications.
- Track and Trend release and stability results as part of product and method life-cycle management
- Participate as needed on investigation teams as the analytical/QC SME.
- Author and review analytical-relevant regulatory submission documents
- Author and review relevant change controls and SOPs.
Competencies Include: - 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 using statistical tools to trend stability data and extrapolate expiry
- Experience in pharmaceutical drug development as a member of a cross-functional/CMC team
- 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
Qualifications:
- 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 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
- 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.
Nuvalent is aware that many companies are dealing with fraudulent job postings on third-party employment search sites and/or individual(s) or entities claiming to be employees of such companies. Those involved are offering fraudulent employment opportunities to applicants, often asking for sensitive personal and financial information, and using such information for criminal activities.
Please be advised that all legitimate correspondence from a Nuvalent employee will come from “@nuvalent.com” email accounts. Automated system response emails from our Greenhouse applicant tracking system come from a “no-reply@greenhouse.io” email address. There are no variations of these email addresses and Nuvalent would not request personal and/or financial information via email. Job opportunities would only be extended after a completed job application is submitted by a candidate and a thorough interview process including 1:1 and/or group interviews via phone, video conferencing and/or in-person.
If you believe you have been contacted by anyone misrepresenting themselves as an employee of Nuvalent, please contact Nuvalent at 857-357-7000. Thank you.