Senior Specialist, GMP Quality Assurance
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.
This role is responsible for maintaining high levels of quality in Nuvalent drug substances, drug products, packaged drug products and finished goods by supporting contract manufacturing organizations (CMOs) and internal partners in Technical Operations.
Ensure Nuvalent and internal / external stakeholders comply with cGMPs and standards as well as regulations of applicable authorities.
- Provide quality oversight throughout the CMC lifecycle management of Nuvalent’s products with a primary focus on Drug Substance and Starting Materials.
- Conduct product release activities for all phases of development including review and approval of master batch records and executed batch records.
- Provide onsite oversight/monitoring of manufacturing campaigns as appropriate.
- Coordinate QP release as appropriate.
- Effectively interact with external contract manufacturers, testing laboratories, and work as part of an internal multidisciplinary team to conduct, review, and approve manufacturing, testing, and product complaint investigations.
- Assist in preparing or reviewing CMC sections of regulatory submissions.
- Supports associated Investigations, CAPAs, Change Controls, Material Review Boards, OOS, etc.
- Work with team to implement/maintain Quality Agreements with suppliers.
- Represent the QA department on Vendor project teams.
- Assist in conducting audits of CMOs and Testing Laboratories.
- Ability to drive and deliver multiple projects within project scope and timelines.
- Proven ability to effectively communicate across all functions.
- Ability to think strategically and tactically deliver.
- Bachelor’s degree in biology, chemistry, life sciences field preferred or related experience.
- 3+ years of experience working in Quality functions supporting cGMP manufacturing of pharmaceutical products.
- Direct experience working with the GMP manufacturing of small molecule drug substances and starting materials is required.
- Direct experience working with drug product manufacturing, packaging, and labeling is preferred.
- Working knowledge of MS Word, MS Teams, Veeva Quality Docs, SharePoint and Smartsheet is preferred.
- Strong knowledge of cGMP regulations, practices, and trends pertaining to pharmaceutical product development, manufacturing, testing, and clinical operations is required.
- Travel approximately 15%
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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