Sr. Director, Drug Product Dev & Manufacturing (On-site)
$200k - $250kFull-time
Corvus Pharmaceutical
This is an onsite role in our South San Francisco offices minimum 4 days per week 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.
- 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.
Vacancy posted 19 days ago
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