Senior Manager - Quality Control

March 19

🍂 Massachusetts – Remote

Although this job is listed in Massachusetts, this company may be open to hiring remote in other states.

⏰ Full Time

🟠 Senior

👔 Manager

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Nuvalent, Inc.

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Nuvalent, Inc. is a biotechnology company focused on developing targeted therapies for patients with cancer. With a strong foundation in chemistry and structure-based drug discovery, Nuvalent designs innovative small molecules to effectively inhibit kinase targets, overcoming challenges of resistance and selectivity. The company collaborates with physician-scientists to address patient needs and limitations of existing therapies, ensuring their solutions are built for patients and driven by a deep sense of purpose. Nuvalent is committed to using their expertise to deliver precisely targeted cancer treatments.

11 - 50 employees

🧬 Biotechnology

💊 Pharmaceuticals

📋 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. • The Role: Reporting to the Associate Director, Analytical Sciences /QC, the Senior Manager, Quality Control will lead the Quality Control 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 regulatory starting material, intermediates, 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, and to coordinate commercial readiness deliverables 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.

🎯 Requirements

• 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. • A strong understanding and knowledge of cGMP/ICH regulations and USP Guidelines with the ability to apply them to analytical drug substance and drug product development and manufacturing is required. • 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 commercialization. • Knowledgeable 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 and application of statistical analysis concepts is preferred.