Nuvalent, Inc. - Senior Manager, Formulation Sciences
Upload My Resume
Drop here or click to browse · Tap to choose · PDF, DOCX, DOC, RTF, TXT
Requirements
• PhD in pharmaceutics, pharmaceutical sciences, chemical engineering or related field with a minimum of 3+ years or MS with 6+ years /BS with 10+ years of industry experience. • Proven track record on drug product process validation, scale up and manufacture for solid dosage form (tablets). • Experience with QbD principles and DOE methodology preferred. • Manage the outsourcing manufacturing activities at CDMO sites to meet CMC goals. • Understanding of cGMP/ICH guidelines and the ability to apply them to development and manufacturing. • Experience with solid dosage form (tablet) process development; exposure to late-stage validation is a plus. • Ability to author and critically review relevant development reports as well as regulatory dossiers. • Up to 25% travel is expected, both domestically and internationally. • Additional Information: • Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages. • The targeted salary range reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors. The range will be reviewed regularly and is subject to change. • Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more.
Responsibilities
• Support drug product Process Validation activities, Scale up and post-approval changes (SUPAC) and routine commercial manufacturing at CDMOs. • Identify critical process parameters based on the risk assessment and understanding the impact of material attributes and process parameters on critical quality attributes. Implement appropriate process controls to ensure delivery of consistent batch product quality. • Draft, coordinate, execute validation protocols, perform data analysis, author/review and approve process validation reports with consistent and effective communication with other functions. • Provide support to routine process validation studies, assisting with product technology transfers or lifecycle management changes such as process improvement, addition of secondary API and manufacture site change etc. • Perform technical review of drug product manufacture deviations, change controls, perform process monitoring (manufacturing data summary and analysis, data presentation), perform activities for drug product lot release (assess deviations and process changes). • Work closely with other team members and cross-functionally with quality assurance, analytical/QC, chemical development, supply chain, and project management team to achieve all project deliverables. • Provide support for technical decision-making regarding cGMP compliance, validation strategy and regulatory pathway for SUPAC changes etc. • Familiar with statistical analysis software, such as JMP. • Perform process capability analysis, identify risk, and make recommendations for process improvement. • Manage documentation, change controls, material inventory, product complaints, and deviation resolution at CDMOs. • Represent the drug product group as a Subject Matter Expert to support audits and regulatory inspections. • Support authoring the relevant technical sections of regulatory filings. • Support late-stage validation and post-approval readiness activities and commercial manufacture activities within a virtual working environment. • Competencies: • Strong organizational, planning, and multitasking skills in a fast‑paced environment. • Excellent relationship‑building and communication skills across diverse teams. • Evidence of effective cross‑functional collaboration with both internal teams and external partners. • Strong problem‑solving and analytical skills with the ability to break down complex issues. • Results‑driven mindset with attention to quality and timelines. A strong understanding and knowledge of cGMP/ICH regulations and an ability to apply them to drug product development and manufacturing is required. • Excellent organization and multi-tasking skills. • Experience building positive and effective cross functional relationships and the ability to align stakeholders, both internally and externally to Nuvalent.
Benefits
• $155,000—$180,000 USD • 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.
No credit card. Takes 10 seconds.