Associate Director, Analytical Development & QC — Lead Analytics

Corvus Pharmaceuticals; South San Francisco (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Corvus Pharmaceuticals in South San Francisco, CA is seeking an Associate Director of Analytical Development & Quality Control to direct internal lab operations and mentor scientists. You will oversee analytical instrumentation, reference standards, and stability programs, and partner with external vendors for phase-appropriate method development to support late-stage programs.

You will also contribute to regulatory filings and write CMC sections, ensuring data integrity and timely delivery of

Qualifications

• Advanced degree in Chemistry, Pharmaceutics, or related field.
• BS/MS with 10+ years or PhD with 7+ years in small molecule development.
• Expertise in HPLC method development is essential.
• Additional techniques: GC, NMR, MS, particle size, solid state, dissolution, ICP-MS/OES, FTIR.
• Understanding of control strategy, method validation, and retest/expiry.
• Experience in analytical development/validation for drug substances and products.
• Experience overseeing CDMOs/CROs.
• Experience managing stability programs, reference standards, and retest expiry.
• Familiar with ICH guidelines, cGMPs, pharmacopeial chapters.
• Experience in OOT/OOE/OOS, deviation management, and change control.
• Ability to interpret data and communicate across disciplines.
• Ability to travel domestically and internationally.

Responsibilities

• Method development and analytical characterization of drug substances, products, and stability.
• Management of method development, validation, QC testing, and reference standards 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 statistics.
• Collaborates on 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 achievement of scientific objectives.
• Monitors and evaluates task completion and project progress.
• Addresses complex issues requiring deep company knowledge.
• Negotiates with vendors and management to influence senior leaders.
• Directs activities across a broad functional area via cross-functional partnerships.

Skills

HPLC method development

Analytical development

Method validation

CDMOs management

ICH guidelines

cGMP knowledge

OOS/OEE/OOO management

Data interpretation

Regulatory writing

Vendor negotiation

Team leadership

Travel readiness

Education

Advanced degree in Chemistry/Pharmaceutics/related field

MS/PhD with 7+ years in industry

Tools

NMR

Mass spectrometry

Gas chromatography

ICP-MS/OES

FTIR

Dissolution testing

Particle size analysis

Job description

Corvus Pharmaceuticals in South San Francisco, CA is seeking an Associate Director of Analytical Development & Quality Control to direct internal lab operations and mentor scientists. You will oversee analytical instrumentation, reference standards, and stability programs, and partner with external vendors for phase-appropriate method development to support late-stage programs.

You will also contribute to regulatory filings and write CMC sections, ensuring data integrity and timely delivery of