The Role:
Reporting to the Senior Director, Formulation Sciences, the Associate Director, Formulation Sciences will act as late-stage drug product subject matter expert and will immediately be responsible for guiding drug product process validation toward commercialization. The successful candidate must demonstrate a proven record of working in a virtual environment with CDMOs to deliver commercial supplies in support of fast-paced late-stage development programs. Using critical and strategic thinking, the Associate Director, must be able to develop and execute the 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 the 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:
The successful candidate will support the company through the following areas/interactions:
•    Responsible for drug product process validation activities and lead Scale up and post-approval changes (SUPAC) and routine commercial manufacturing.
•    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, and 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 leadership and technical decision-making regarding cGMP compliance, validation strategy and regulatory pathway for SUPAC changes etc.
•    Mastery of statistical analysis software, such as JMP or similar.
•    Perform process capability analysis, identify risk, and make recommendations for process improvement. 
•    Represent the drug product group as a Subject Matter Expert in audits and regulatory inspections.
•    Support authoring of the relevant technical sections of regulatory filings.

 
Competencies:
•    Excellent organization, communication and multi-tasking skills.
•    Experience building positive and effective cross functional relationships and the ability to align stakeholders, both internally and externally to Nuvalent.
•    Demonstrated critical thinking skills and the ability to anticipate and plan for challenges.
•    Ability to strategically plan, organize, and manage multiple projects simultaneously.

Qualifications: 
•    PhD in pharmaceutical sciences, or chemical engineering with a minimum of 8 years or MS/BS with 15+ years of industry experience.
•    Proven track record on drug product process validation, scale up and post-approval changes and commercial manufacture. 
•    Must have experience on solid dosage form (tablet) late-stage process validation through commercialization. 
•    A strong understanding and knowledge of CGMP/ICH regulations and an ability to apply them to drug product development and manufacturing is required.
•    Effectively manage late-stage validation, post-approval changes and commercial manufacture activities within a virtual working environment.
•    Experience with implementation of QbD strategies and DoE approach during drug product Life-cycle management.
•    Manage the outsourcing manufacturing activities at CDMO sites to meet CMC goals.
•    Mastery of current ICH guidelines and related industry guidelines and practices.
•    Ability to author and review relevant development reports as well as regulatory dossiers.
•    Up to 25% travel is expected, both domestically and internationally.