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 experience supporting late-stage clinical, registration, and commercial products.
• Extensive experience with analytical method development, validation, transfer, and lifecycle management.
• Proven experience authoring and reviewing NDA, MAA, and global regulatory submissions.
• Significant FDA and global health authority interaction experience.
• Demonstrated success supporting Pre-Approval Inspections (PAIs) and regulatory inspections.
• Experience managing CMOs, CDMOs, CROs, and external testing laboratories.
• Strong experience with analytical strategy, stability programs, specification setting, reference standards, and product lifecycle management.

Preferred

• Experience working with CMOs/CDMOs and global manufacturing networks.
• Experience in respiratory or other fibrotic disease programs, or with small-molecule products in late-stage development.

Why Join Celea Therapeutics

• Play a pivotal role in advancing life-changing therapies for patients with devastating lung diseases.
• Shape the foundation of a Phase 3-ready biotech poised for significant growth.
• Collaborate with a passionate, mission-driven leadership team.
• Competitive compensation and equity package.

Compensation

Transparency is one of our values, and that includes how we pay. The anticipated salary range for the Associate Director level is $190,000 - $205,000, plus bonus and equity; for the Director level the range is $220,000 - $235,000 plus bonus and equity. Where an offer lands within the range reflects the candidate's experience, skills, and internal equity - and we welcome open conversations about compensation from the first call, so there are no surprises at the offer stage.

Actual compensation will be determined based on experience, qualifications, and location. In addition to base pay, this role is eligible for bonus and equity compensation.

Base Pay Information

$190,000-$235,000 USD