Sr. Director, Drug Product Dev & Manufacturing (On-site)

ROLE AND RESPONSIBILITIES

• Define and lead drug product development strategy for Corvus’ programs.
• Develop robust, scalable formulations and drug product manufacturing processes that ensure product quality.
• Establish specifications and control strategies aligned with global regulatory and quality expectations. Serve as a scientific and technical expert in formulation challenges for investigational drugs.
• Oversee technical activities at drug product CMOs, including technology transfer, clinical trial material (CTM) production, process troubleshooting, QbD and PAR studies, risk assessments, registration batch production, and process validation.
• Coordinate with Quality and Supply Chain teams to ensure timely manufacture and release of drug product lots by leading technical reviews of batch records, deviations, change controls, and nonconformance investigations; proactively identify and mitigate risks related to clinical supply.
• Partner with Chemical Development and Analytical Development functions to define optimal drug substance properties and control strategies.
• Ensure adherence to applicable regulations and guidelines, including FDA, EMA, ICH, GCP, and GMP.
• Provide person-in-plant support for drug product manufacturing.
• Serve as the drug product subject matter expert for internal program teams, due diligence activities, and CMO selection, management, and audits.
• Author and review CMC sections of regulatory filings, including INDs, IMPD/IND amendments, and NDA/MAA submissions.
• Cook up with Analytical teams to ensure expiry and retest dating are current and aligned with drug product supply and commercialization plans.
• Contribute to internal and external presentations and publications.
• Manage, mentor, and develop scientists and engineers.
• Writes and reviews manuscripts for publication.
• Develops strategies to ensure effective achievement of scientific objectives. Monitors and evaluates completion of tasks and projects.
• Makes final decisions on administrative or operational matters and ensures operations effective achievement of objectives.
• Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company and its objectives.
• Ensures that budgets and schedules meet corporate timelines.
• Must have strong negotiation skills with vendors and management to influence senior leaders regarding matters of significance to the organization.
• Directs and controls the activities of a broad functional area through partnership with cross-functional department managers within the company.

QUALIFICATIONS

• Ph.D. in Chemistry, Pharmaceutical Sciences, Engineering, or a related discipline with at least 10 years of late-phase, including NDA/MAA filing, small-molecule drug product development experience (M.S. with 15+ years considered).
• Extensive experience in GMP oral solid dose manufacturing, including spray drying, granulation, hot melt extrusion, tableting, and encapsulation.
• Significant experience managing third-party drug product CMOs, including tech transfer, QbD studies, clinical supply production, registration batches, and commercial launch activities.
• Strong understanding of product/packaging interactions, barrier properties, stability, global packaging regulations, and package testing.
• In-depth knowledge of cGMP, ICH, FDA, and EMA requirements.
• Proven ability to collaborate effectively across internal and external stakeholders.
• Excellent written and verbal communication skills with strong problem-solving capabilities.
• Able to manage multiple priorities in a fast-paced environment and navigate complex technical challenges.
• Willingness to travel domestically and internationally up to 25%.
• Excellent teamwork and collaboration skills.
• Flexibility and willingness to solve problems that fall outside of immediate area of expertise.
• Clear and concise verbal and written communication skills and strong organizational skills, with an exceptional attention to detail.
• Work independently in an interdisciplinary, fast-paced, often changing environment.
• Committed to the values of integrity, accountability, transparency, and drive.