Director of Analytical Development - Peptide & Biologics

JLSa2 Therapeutics, Inc.; South San Francisco (CA); On-site; USD 175,000 - 225,000; Full time

Job summary

JLSa2 Therapeutics, Inc. is seeking an Associate Director/Director of Analytical Development to lead the analytical strategy for peptide intermediates, DS, and DP.

You will design phase-appropriate methods, oversee method development, and supervise external partners to ensure robust data for regulatory submissions. The role requires hands-on leadership, deep expertise in peptide/biologics analytics, and experience managing CDMOs in a fast-paced biotech setting, contributing to pivotal

Qualifications

• PhD with 10+ years in analytical development for peptides/biologics.
• Demonstrated leadership in biotech analytical teams and external partner management.
• Experience transferring methods to CDMOs and ensuring regulatory readiness.

Responsibilities

• Lead and implement analytical development strategy for peptide intermediates, DS, and DP across development stages.
• Oversee method development, qualification, transfer, and validation (HPLC/UPLC, LC‑MS, peptide mapping).
• Manage external partners (CDMOs/CROs) and monitor performance, data review, and CAPAs.
• Support regulatory submissions with analytical sections and regulatory interactions.
• Collaborate cross‑functionally with Process Development, Manufacturing, Quality, Regulatory, and Clinical teams.
• Build and mentor the internal analytical team and implement best practices and infrastructure.

Skills

Analytical chemistry

Leadership

CDMO management

OOS/OOT investigations

Regulatory understanding

Education

PhD in Analytical Chemistry

MS in related field

BS with extensive experience

Tools

HPLC/UPLC

LC-MS

Peptide mapping

Impurity profiling

ICH guideline familiarity

Job description

JLSa2 Therapeutics, Inc. is seeking an Associate Director/Director of Analytical Development to lead the analytical strategy for peptide intermediates, DS, and DP.

You will design phase-appropriate methods, oversee method development, and supervise external partners to ensure robust data for regulatory submissions. The role requires hands-on leadership, deep expertise in peptide/biologics analytics, and experience managing CDMOs in a fast-paced biotech setting, contributing to pivotal