Strategic Associate Director, Analytical Development & QC

Corvus Pharmaceuticals, Inc.; South San Francisco (CA); In loco; USD 180.000 - 240.000; Tempo pieno

Descrizione del lavoro

Corvus Pharmaceuticals, Inc. is seeking an Associate Director Analytical Development & Quality Control to lead internal laboratory operations within the Chemistry, Manufacturing & Controls group and to mentor scientists while guiding analytical instrumentation, reference standards and stability programs.

Reporting to the Director of Analytical Development and Quality Control, you will drive phase-appropriate method development, support regulatory filings (IND/IMPD/NDA/MAA), and collaborate with

Competenze

• Advanced degree in Chemistry/Pharmaceutics or related field.
• PhD with 7+ years or MS/BS with 10+ years in small molecule pharmaceutical development.
• Expertise in HPLC method development is essential.
• Experience with CDMOs/CROs and stability programs.
• Strong knowledge of ICH, cGMPs, and pharmacopeial chapters.
• Ability to manage analytical activities and timelines.
• Ability to travel domestically and internationally.

Mansioni

• Lead method development and analytical characterization of drug substances/products.
• Oversee method development, validation, QC testing, and reference standard management.
• Manage stability studies and reference standards; coordinate with CDMOs/CTLs.
• Drive OOS/OOE/OOT investigations and deviation handling.
• Review data, protocols, and documentation for regulatory filings.
• Develop strategies to meet project timelines and objectives.
• Mentor scientists and collaborate with cross-functional teams.
• Prepare CMC sections of IND/IMPD/NDA/MAA and contribute to publications.

Conoscenze

HPLC

Analytical method development

Leadership / Mentoring

Regulatory writing (CMC)

Vendor management

Statistical analysis

ICH/gCMP knowledge

Cross-functional collaboration

Travel willingness

Formazione

Advanced degree in Chemistry/Pharmaceutics

BS/MS with 10+ years or PhD with 7+ years

Strumenti

Gas Chromatography

NMR

Mass Spectrometry

Dissolution testing

ICP-MS/OES

FTIR

Particle Size Analysis

Descrizione del lavoro

Corvus Pharmaceuticals, Inc. is seeking an Associate Director Analytical Development & Quality Control to lead internal laboratory operations within the Chemistry, Manufacturing & Controls group and to mentor scientists while guiding analytical instrumentation, reference standards and stability programs.

Reporting to the Director of Analytical Development and Quality Control, you will drive phase-appropriate method development, support regulatory filings (IND/IMPD/NDA/MAA), and collaborate with