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Job description
Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company developing novel therapies with the potential to significantly improve the treatment of immune diseases and cancer. Our lead program, soquelitinib, is a first-in-class oral therapy that selectively inhibits ITK to modulate and control parallel signaling pathways in the immune system.
Reporting to the Director of Analytical Development and Quality Control, the Associate Director of Analytical Development & Quality Control will serve as a key member of the CMC team, directing internal laboratory operations and mentoring scientists while overseeing analytical instrumentation, reference standards, and stability programs. In this dynamic role, you will also partner with external vendors to drive phase-appropriate analytical method development, with a strong focus on late-stage programs, and provide critical analytical support for regulatory filings.
Role and Responsibilities
Method development for and analytical characterization of drug substances, drug products, and product stability
Management of method development, method validation, QC testing, and reference standard management activities internally and at CDMOs/CTLs
Management of forced degradation, long term stability, and predictive stability studies
Contribution to OOS/OOE/OOT investigations
Critical review of data, protocols, reports, specifications, and other documentation
Trending stability data and establishing retest periods/shelf life using statistical methods
Conducts and collaborates with others on the principles of chemical development, and scale-up.
Authors and contributes to writing CMC sections of regulatory documents (IND/IMPD/NDA/MAA).
Writes and reviews manuscripts for publication.
Develops strategies to ensure effective achievement of scientific objectives.
Monitors and evaluates completion of tasks and projects.
Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company and its objectives.
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:
Advanced degree in a relevant discipline (Chemistry, Pharmaceutics, or related field)
BS/MS degree with 10+ years or PhD with 7+ years of industrial experience in small molecule pharmaceutical development
Expertise in HPLC method development is essential
Additional experience in techniques such as gas chromatography, NMR, mass spectrometry, particle size analysis, solid state characterization, dissolution, ICP-MS/OES, and/or FTIR are important
Solid understanding of phase-appropriate approaches to control strategy, method validation, and retest/expiry
Experience in analytical development and validation for drug substances, starting materials, synthetic intermediates, and solid oral drug products
Experience in management of analytical activities at CDMOs/CROs
Experience managing stability programs, reference standards, and retest/expiry
Familiarity with ICH guidelines, cGMPs, and pharmacopeial chapters
Experience in OOT/OOE/OOS management, deviation management, and change control
Ability to critically interpret data and articulate technical concepts in multidisciplinary settings
Ability to ensure assigned activities are completed in satisfaction of project timelines
Strong interpersonal skills that foster collaboration within and outside of the organization
Ability to travel domestically and internationally
Preferred Skills:
Excellent teamwork and collaboration skills
Proficient with Microsoft Office.
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.
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Worksite address
south san francisco, CA, 94083, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.