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, GMP QA, the Senior Manager, GMP QA 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 GMPs and standards as well as regulations of applicable authorities.
Responsibilities:
• Provide quality oversight throughout the CMC lifecycle management of Nuvalent’s products with a primary focus on packaging, labeling and serialization operations, including review and approval of GMP protocols and reports.
• Participates in risk assessment for design, process and product FMEAs.
• Conduct product disposition 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.
• Assist in the Development, Review and approval Annual Product Reviews (Vendor and Internal)
• 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.
Competencies:
• Ability to drive and deliver multiple projects within project scope and timelines.
• Proven ability to effectively communicate and collaborate across all functions
• Ability to work productively primarily from home in a fast-paced, results-driven, highly accountable environment
• Strong written and verbal communication skills and demonstrated ability to work both independently and collaboratively with people at different levels
• Excellent organizational skills, attention to detail, and ability to multi-task and handle multiple projects simultaneously in a fast-paced, deadline-driven, cross-functional environment
Qualifications:
• Bachelor’s degree in biology, chemistry, life sciences field preferred or related experience.
• 7+ years of experience working in Quality functions supporting cGMP manufacturing of pharmaceutical products.
• Commercial and packaging validation experience required
• Direct experience working on artwork development, serialization and product launch 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.
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 “[email protected]” 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.
Top Skills
What We Do
Nuvalent is creating precisely targeted therapies for patients with cancer designed to overcome the limitations of existing therapies for clinically proven kinase targets. Leveraging deep expertise in structure-based design, Nuvalent develops innovative small molecules with exquisite target selectivity to overcome resistance, minimize adverse events, and drive more durable responses. Nuvalent is advancing a robust pipeline with parallel lead programs in ROS1-positive and ALK-positive NSCLC, along with multiple discovery-stage research programs. To learn more, visit www.nuvalent.com.
