Director, Drug Product Development and Manufacturing

Department/Group: CMC
Location: South San Francisco, CA
Position Type: Full time


Job Description

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
  • Coordinate 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.
  • May develop budgets for capital expenditures and labor.
  • Collaborates with other top managers to establish company policies.
  • Leads the selection, development and evaluation of personnel to ensure the efficient operation of the function.
  • 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 and Education Requirements

  • 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
  • Demonstrated expertise in formulation development and manufacturing of enabled formulations
  • 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
  • Ability 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 
  • Able to build effective working relationships throughout the organization internally and externally to achieve goals.
  • 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.

Salary Range: $200,000 to $250,000

If you are interested, please submit a cover letter and your resume to careers@corvuspharma.com