Senior 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. seeks a seasoned pharmaceutical development leader to drive analytical method development and regulatory CMC activities for small molecule programs.

You will oversee method development, validation, QC testing, and stability studies, collaborating with CDMOs/CROs and cross-functional teams to mitigate risks and meet timelines. The role requires an advanced degree with 10+ years of industrial experience, strong expertise in HPLC, and excellent communication skills to

Competenze

• Advanced degree in a relevant discipline (Chemistry, Pharmaceutics, or related field).
• 12+ years (or PhD with 10+ years) of industrial experience in small molecule pharmaceutical development.
• Expertise in HPLC method development is essential.
• Experience with GC, NMR, MS, particle size analysis, solid state characterization, dissolution, ICP-MS/OES, FTIR.
• Familiarity with ICH guidelines, cGMPs, and pharmacopeial chapters.
• Experience in analytical development and validation for drug substances, starting materials, intermediates, and solid oral drug products.
• Experience in management of analytical activities at CDMOs/CROs.
• Experience managing stability programs, reference standards, and retest/expiry.
• Experience with OOS/OOE/OOT management, deviation management, and change control.
• Strong data interpretation and communication in multidisciplinary settings.
• Ability to travel domestically and internationally.

Mansioni

• Characterize drug substance and product attributes and identify technical risks.
• Develop methods for analytical characterization of drugs and products.
• Manage method development, validation, QC testing, and reference standard programs.
• Oversee stability studies, forced degradation, and retest expiry strategies.
• Contribute to OOS/OOE/OOS investigations and data reviews.
• Author CMC sections of IND/IMPD/NDA/MAA regulatory documents.
• Lead and develop analytical development teams and coordinate CDMOs/CROs.
• Ensure regulatory timelines and corporate objectives are met.
• Collaborate with senior leaders to shape development strategies.
• Travel domestically and internationally as needed.

Conoscenze

Negotiation

Interpersonal skills

Leadership

Collaboration

Problem solving

Formazione

Advanced degree in Chemistry/Pharmaceutics

BS/MS with 12+ years or PhD with 10+ years industrial experience

Strumenti

Microsoft Office

Descrizione del lavoro

Corvus Pharmaceuticals, Inc. seeks a seasoned pharmaceutical development leader to drive analytical method development and regulatory CMC activities for small molecule programs.

You will oversee method development, validation, QC testing, and stability studies, collaborating with CDMOs/CROs and cross-functional teams to mitigate risks and meet timelines. The role requires an advanced degree with 10+ years of industrial experience, strong expertise in HPLC, and excellent communication skills to