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Senior Manager, Quality Control - Cambridge, United States - Nuvalent, Inc.
Description
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:
Reporting to the Associate Director, Analytical Sciences /QC, the Senior Manager, Quality Control will support analytical activities for a late-stage small molecule oncology program in the Analytical Sciences team.
The successful candidate needs to demonstrate a proven track record of working with CROs/CMOs to support the in-process, release and stability testing of regulated starting material, drug substance and drug product, as well as the review of manufacturing and distribution documents for clinical and marketed product.
The ability to thrive in a virtual environment in support of developing and delivering drug substance (DS) and drug product (DP) for fast-paced clinical development programs will be critical.
As the Quality Control expert, the candidate is accountable for ensuring all company, regional, and global GMP and GDP standards and regulations are met, and that the GMP Quality Control department performs to a standard that ensures the quality of products and materials produced by our contracted partners.
The candidate will interface with the program's Analytical, Drug Substance, Drug Product, Quality Assurance, and Regulatory CMC functional representatives.Responsibilities include ensuring that drug substance and drug product QC support is timely, high quality, and consistent with the Phase-Appropriate strategy outlined by the project team and CMC Team.
Responsibilities:
QC review of analytical release data for completeness, accuracy, consistency with specifications and/or protocol design as applicable.
Tabulate, assess and archival of stability testing data as part of product and method life cycle management. Identify trends and ensure data is analyzed to help understand degradation pathways in aid of product life cycle.
Assemble data packages in support of shelf-life extensions, specification and method changes associated batch records and related data.
Investigate and resolve analytical test failures (OOS and atypical results) with support of cross-functional team.
Work with Internal teams, CMOs and Test Labs to manage the method and specification life cycles.
Management of the reference standard program.
Author and/or review QC sections (e.g., batch analysis, analytical methods, reference standard, etc) of regulatory submission documents, as well as author and review relevant change controls and SOPs.
Contribute to appropriate sections of CMC sections for submission as well as Annual Product Reviews. Participate in vendor and internal audits as needed.Contribute to company quality systems.
Competencies Include:
Excellent organization and multi-tasking skills and Ability to drive and deliver multiple projects within project scope and timelines.
Relationship Building
Adaptability/Flexibility
Qualifications:
BS or equivalent in chemistry or related discipline with a minimum of eight (8) years of relevant industry experience (or MS/PhD with 5+ years' experience) with at least 2 of those years at the QC Manager level.
Knowledge of analytical testing concepts in small-molecule Drug Substance and Drug Product including laboratory controls and good documentation practices.Ability to author and review relevant documentation (methods, protocols, reports) as well as regulatory sections.
Ability to work with all levels of organization and external contract service providers to ensure compliance with current regulations.
Good understanding of product process and development, from discovery to commercializationKnowledgeable in CGMP regulations and ICH or other industry guidance.
Proven track record solving analytical and QC challenges with a focus on small molecules.Proficiency with JMP is preferred.
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 "" email accounts. Automated system response emails from our Greenhouse applicant tracking system come from a "no-" 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 Thank you.
