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 Senior Scientist, QC/Analytical Sciences will be a contributing member of the Technical Operations Team, as a part of cross-functional CMC teams for Quality Control from development candidate nomination through development and commercialization of various clinical programs. The successful candidate needs to demonstrate a proven track record of working in a virtual environment with CROs/CMOs to deliver high quality analytical data in support of developing and delivering drug substance (DS) and drug product (DP) for fast-paced clinical development programs. Using strategic thinking, strong technical QC and analytical experience, and an effective knowledge of industry guidance and best practices, the candidate will support DS and DP development and production efforts, analytical method development and validation, contribute to 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/QC, the Sr. Scientist has responsibility for the QC aspects of drug substance and drug product development and manufacturing activities for given products. The team member will collaborate with the Analytical Development, Drug Substance, Drug Product, Quality Assurance, and Regulatory CMC functional teams on those programs to which they contribute. Responsibilities include managing CRO/CDMOs to ensure high quality product release and stability data, providing input on and review of analytical method development and validations, and ensuring consistency with phase appropriate industry standards, and cGMP requirements.
The successful candidate will drive value through the following areas / interactions:
Responsibilities:
- Help define and execute on QC and analytical strategy for Nuvalent development candidates
- Ensuring high quality review of data and consistency with industry guidance/best practices
- QC review of validation, production release, and stability data for completeness, accuracy, and consistency with specifications and Nuvalent SOPs, as well as appropriate cGMP
- Design and execution of phase appropriate stability studies
- Track and Trend release and stability results as part of product and method life-cycle management
- Participation in shelf-life extension strategy for various Nuvalent Products
- Act as contributing team member of various CMC teams
- Participate in the strategic definition and justification of phase-appropriate SM, Intermediate, DS, and DP specifications
- Participate as needed on investigation teams as the QC SME
- Contribute to 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
- Previous exposure to 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 8 -12 years of relevant industry experience OR PhD in chemistry or related discipline with a minimum of 2 years of industry 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.