Senior Director, Biologics Analytical Development

Avalo Therapeutics; Chesterbrook (PA); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Avalo Therapeutics in Chesterbrook, PA is seeking a Director of Analytical Development to provide strategic leadership for analytical development across late-stage programs, with emphasis on Phase 3 readiness and commercial-scale transfer.

The role requires strong collaboration with upstream/downstream manufacturing, QA, Regulatory Affairs, and external CROs/CDMOs to ensure robust, compliant, and scalable analytical strategies.

Qualifications

• Ph.D., M.S., or B.S. in analytical sciences or related field.
• 10+ years in biopharmaceutical analytical development and related areas.
• Experience supporting late-stage biologics development (Phase 3).
• Experience with analytical method development, qualification, validation, and transfer.
• Experience managing external CROs/CDMOs and regulatory interactions.

Responsibilities

• Provide strategic leadership for analytical development across clinical phases.
• Lead development of phase-appropriate control strategies and specifications.
• Oversee method lifecycle management and transfer to commercial testing.
• Ensure GMP-compliant analytical practices and regulatory readiness.
• Collaborate with QA, Regulatory, Manufacturing, and external partners.

Skills

Analytical leadership

Biologics

Regulatory strategy

Project management

Cross-functional

Education

PhD in Analytical Chemistry

Tools

Mass spectrometry

LIMS

Job description

Avalo Therapeutics in Chesterbrook, PA is seeking a Director of Analytical Development to provide strategic leadership for analytical development across late-stage programs, with emphasis on Phase 3 readiness and commercial-scale transfer.

The role requires strong collaboration with upstream/downstream manufacturing, QA, Regulatory Affairs, and external CROs/CDMOs to ensure robust, compliant, and scalable analytical strategies.