Senior Director - Drug Product Development & Manufacturing
Full-Time
$200k - $250k
Expert
Master's, PhD
South San Francisco, CA, USA
HybridOn-site at the South San Francisco office at least four days per week.
Biology & BiotechBioprocess & Biomanufacturing
About the job
Requirements
A Ph.D. in Chemistry, Pharmaceutical Sciences, Engineering, or a related discipline with at least 10 years of late-phase small-molecule drug product development experience, including NDA/MAA filing experience; an M.S. with 15 or more years of experience is 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 contract manufacturing organizations, including technology transfer, Quality by Design studies, clinical supply production, registration batches, and commercial launch activities.
Strong understanding of product and packaging interactions, barrier properties, stability, global packaging regulations, and package testing.
In-depth knowledge of current Good Manufacturing Practices, International Council for Harmonisation guidelines, and Food and Drug Administration and European Medicines Agency requirements.
Ability to collaborate effectively across internal and external stakeholders.
Ability to manage multiple priorities in a fast-paced environment and navigate complex technical challenges.
Willingness to travel domestically and internationally up to 25%.
Ability to build effective working relationships throughout the organization, internally and externally, to achieve goals.
Ability to work independently in an interdisciplinary, fast-paced, often changing environment.
Strong negotiation skills with vendors and management to influence senior leaders on matters of significance to the organization.
Responsibilities
Define and lead drug product development strategy for the company’s 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, and serve as a scientific and technical expert in formulation challenges for investigational drugs.
Oversee technical activities at drug product contract manufacturing organizations, including technology transfer, clinical trial material production, process troubleshooting, Quality by Design and proven acceptable range 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 Food and Drug Administration, European Medicines Agency, International Council for Harmonisation, Good Clinical Practice, and Good Manufacturing Practice requirements.
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 contract manufacturing organization selection, management, and audits.
Author and review Chemistry, Manufacturing, and Controls sections of regulatory filings, including Investigational New Drug applications, Investigational Medicinal Product Dossiers, amendments, and New Drug Application/Marketing Authorization Application 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.
Write and review manuscripts for publication.
Develop strategies to ensure effective achievement of scientific objectives and monitor and evaluate completion of tasks and projects.
May develop budgets for capital expenditures and labor.
Collaborate with other top managers to establish company policies.
Lead the selection, development, and evaluation of personnel to ensure efficient operation of the function.
Make final decisions on administrative or operational matters and ensure operations effectively achieve objectives.
Work on complex issues where analysis of situations or data requires in-depth knowledge of the company and its objectives.
Ensure budgets and schedules meet corporate timelines.
Direct and control the activities of a broad functional area through partnership with cross-functional department managers within the company.
Desired Qualifications
Excellent written and verbal communication skills.
Strong problem-solving capabilities.
Excellent teamwork and collaboration skills.
Flexibility and willingness to solve problems outside the immediate area of expertise.
Strong organizational skills and exceptional attention to detail.
Commitment to integrity, accountability, transparency, and drive.
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.
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.