Senior Director, Analytical Development & Strategy

5AM Ventures; Emeryville (CA); In loco; USD 225.000 - 275.000; Tempo pieno

Descrizione del lavoro

Prolynx is a fast-moving biotechnology company based in Emeryville, CA, seeking a Director of Analytical Development to lead development, qualification, validation, and implementation of analytical methods for preclinical and clinical programs.

The ideal candidate will establish the analytical strategy across starting materials, drug substance, and drug product, while coordinating with external CROs/CDMOs to ensure GMP readiness and regulatory readiness.

Competenze

• Ph.D. in a relevant scientific discipline with 10+ years in pharma/biotech analytical development.
• Experience developing/qualifying/validating analytical methods for complex molecules.
• Experience supporting CMC activities for regulatory submissions.
• Leadership of analytical development teams and CRO/CDMO oversight.
• Strong data interpretation and scientific decision making.
• Excellent written and verbal communication.

Mansioni

• Develop and execute the analytical development strategy across the pipeline.
• Define analytical requirements for starting materials, drug substance and drug product.
• Lead method development, qualification, validation and lifecycle strategies.
• Oversee GMP readiness and regulatory support for INDs.
• Manage external CROs/CDMOs and ensure timely deliverables.
• Collaborate with QA, Regulatory, Process Development, Manufacturing, and other functions.

Conoscenze

Analytical method development

Method validation

Regulatory submissions

Leadership

Communication

Formazione

Ph.D. in Analytical Chemistry or related

Strumenti

HPLC/UPLC

LC-MS

SEC

Ion-exchange chromatography

Peptide mapping

Descrizione del lavoro

Prolynx is a fast-moving biotechnology company based in Emeryville, CA, seeking a Director of Analytical Development to lead development, qualification, validation, and implementation of analytical methods for preclinical and clinical programs.

The ideal candidate will establish the analytical strategy across starting materials, drug substance, and drug product, while coordinating with external CROs/CDMOs to ensure GMP readiness and regulatory readiness.