Senior Manager, Formulation Sciences

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, Formulation Sciences, the Senior Manager, Formulation Sciences will act as late-stage drug product subject matter expert and will support drug product process validation toward commercialization. The successful candidate needs to demonstrate a proven record of working in a virtual environment with CDMOs to deliver clinical and commercial supplies in support of fast-paced late-stage development programs. Using strategic thinking, the Senior Manager must be able to develop and execute process validation strategies for successful product commercialization.This individual has responsibility for support of drug product process validation, scale up, and post-approval changes (SUPAC) and routine commercial manufacturing activities across Nuvalent’s contract research and manufacturing organizations. The primary accountability is being the steward for product development and manufacturing as these programs transition through development and into commercialization. The ultimate goal will be to ensure robust process and manufacture strategies for consistent commercial supply.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.Qualifications: 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