Director of Analytical Development & GMP Strategy

Prolynx; Emeryville (CA); In loco; USD 190.000 - 230.000; Tempo pieno

Descrizione del lavoro

Prolynx, a Emeryville, CA biotech, seeks a Director of Analytical Development to lead method development and validation across preclinical and clinical programs. You will shape analytical strategy for starting materials, drug substance, and drug product, supervise CROs/CDMOs, and ensure GMP readiness for regulatory submissions.

The ideal candidate has 10+ years in analytics, expertise with peptides/PEGylated molecules, and a track record of building analytical teams in a fast-paced environment.

Competenze

• Ph.D. in Analytical Chemistry or related discipline with 10+ years of pharma/biotech experience.
• Strong track record in analytical method development, qualification, and validation.
• Experience with GMP labs and external analytical testing organizations.
• Ability to interpret complex analytical data and make sound decisions.
• Excellent written and verbal communication skills; thrives in a small team.

Mansioni

• Develop and execute analytical development strategy across preclinical to clinical stages.
• Lead method development, qualification, validation, and lifecycle management.
• Characterize peptides/PEG-containing molecules and related species.
• Ensure GMP readiness and support regulatory submissions (CMC, IND).
• Manage CROs/CDMOs and external analytical partners; provide scientific oversight.

Conoscenze

Excellent communication

Analytical reasoning

Cross-functional collaboration

Team leadership

Scientific decision making

Formazione

Ph.D. in Analytical Chemistry

Strumenti

HPLC/UPLC

LC-MS

SEC

Ion-exchange chromatography

Peptide mapping

Descrizione del lavoro

Prolynx, a Emeryville, CA biotech, seeks a Director of Analytical Development to lead method development and validation across preclinical and clinical programs. You will shape analytical strategy for starting materials, drug substance, and drug product, supervise CROs/CDMOs, and ensure GMP readiness for regulatory submissions.

The ideal candidate has 10+ years in analytics, expertise with peptides/PEGylated molecules, and a track record of building analytical teams in a fast-paced environment.