Associate Director​/Director, Analytical Steward, CMC Boston

Associate Director/Director, Analytical Steward, CMC

About Celea Therapeutics

Celea Therapeutics is dedicated to advancing transformative treatments for people with serious respiratory diseases. Drawn from the Latin word for “sky,” our name reflects our mission to rise above the status quo and deliver therapies that change lives. Our lead program, deupirfenidone (LYT-100), is currently in Phase 3 clinical development with active candidate enrollment, representing a potential new standard of care for idiopathic pulmonary fibrosis (IPF) and other fibrotic lung diseases.

Rising above the status quo takes a team as strong as its science, and we hire and work by five values:
accountability — owning outcomes and acting like owners;
transparency — talking straight and building trust;
collaboration — achieving together what no one could alone;
innovation — challenging accepted ideas and taking smart risks; and passion — bringing energy and heart to the mission.

Position Overview

As we prepare for our next stage of growth and clinical advancement, Celea is seeking an experienced, strategic, and hands-on Associate Director/Director, Analytical Stewart, CMC to serve as the end-to-end technical owner for analytical activities across the product lifecycle. Reporting to the Senior Vice President, CMC
, this role provides strategic, scientific, and operational leadership for analytical development activities supporting late-stage clinical, registration, and commercial small molecule products. Analytical activities include phase-appropriate analytical method development, qualification, validation, transfer, and lifecycle management for regulatory starting materials, intermediates, drug substance, and drug product. The role is accountable for analytical control strategies, specifications, stability programs, reference standards, regulatory submissions, inspection readiness, and oversight of all analytical activities performed at CMOs, CDMOs, CROs, and contract testing laboratories.

This position is based in Boston, Hybrid with 3 days/onsite.

Key Responsibilities

• Develop and execute analytical strategies supporting phase appropriate development of regulatory starting materials, intermediates, drug substance and drug product of assigned projects.
• Oversee all analytical activities at CMOs engaged in manufacturing drug substance and drug products.
• Review and approve method development reports, validation protocols, validation reports, analytical procedures, transfer reports, and technical documentation.
• Establish analytical control strategies that support product quality, process robustness, regulatory compliance, and robust manufacturing.
• Collaborate with Drug Substance and Drug Product teams to establish IPC strategies and acceptance criteria.
• Develop and oversee stability strategies and studies for regulatory starting materials, intermediates, drug substance, and drug product. Ensure compliance with ICH, FDA, EMA, and other global regulatory requirements.
• Establish scientifically justified acceptance criteria utilizing process capability, manufacturing experience, analytical data, stability data, and regulatory expectations. Ensure specifications remain appropriate throughout the product lifecycle.
• Oversee development, characterization, qualification, certification, and lifecycle management of primary and working reference standards.
• Ensure analytical methods and programs are inspection-ready and aligned with global regulatory expectations.
• Provide analytical leadership for process validation, technology transfers, product launches, continued process verification, and lifecycle management activities.
• Author analytical sections of global regulatory documents.

Qualifications

Required

• Ph.D. in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or related scientific discipline preferred.
• M.S. or B.S. degree with significant relevant industry experience will be considered.
• 12+ years of experience in biopharmaceutical or pharmaceutical development and manufacturing, including significant experience in drug substance and drug product manufacturing, technical operations, process development, or manufacturing sciences.
• Demonstrated…