Senior Director, Drug Product Development & Manufacturing

Corvus Pharmaceuticals, Inc.; San Francisco (CA); In loco; USD 250.000 - 350.000; Tempo pieno

Descrizione del lavoro

Corvus Pharmaceuticals, Inc. in South San Francisco, CA, seeks a Director/Senior Director of Drug Product Development and Manufacturing to lead the drug product development strategy for its programs.

You will develop robust formulations and manufacturing processes ensuring quality, and manage CMO partnerships and regulatory engagements. The role requires deep GMP knowledge, experience with NDA/MAA filings, and strong leadership to mentor scientists while ensuring regulatory compliance and

Competenze

• PhD in Chemistry, Pharmaceutical Sciences, Engineering or related field with at least 10 years of late-phase, including NDA/MAA filing, small-molecule drug product development experience
• Extensive GMP oral solid dose manufacturing experience 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 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 to achieve goals
• Flexibility and willingness to solve problems outside immediate area of expertise
• Clear and concise verbal and written communication skills with exceptional attention to detail
• Work independently in interdisciplinary, fast-paced, often changing environment
• Committed to integrity, accountability, transparency, and drive

Mansioni

• 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, 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.
• Maks 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.

Descrizione del lavoro

Corvus Pharmaceuticals, Inc. in South San Francisco, CA, seeks a Director/Senior Director of Drug Product Development and Manufacturing to lead the drug product development strategy for its programs.

You will develop robust formulations and manufacturing processes ensuring quality, and manage CMO partnerships and regulatory engagements. The role requires deep GMP knowledge, experience with NDA/MAA filings, and strong leadership to mentor scientists while ensuring regulatory compliance and