Director, Analytical Stewardship (CMC)

Celea Therapeutics, Inc.; Boston, Northern (MA, KY); Hybrid; USD 190,000 - 235,000; Full time

Benefits offered by this job

Equity package

Job summary

Celea Therapeutics, Inc. is seeking an experienced, strategic, and hands-on Associate Director/Director, Analytical Steward, CMC to serve as the end-to-end technical owner for analytical activities across the product lifecycle.

Based in Boston, this hybrid role drives phase-appropriate development, regulatory submissions, and lifecycle management for drug substances and products. You will lead analytical strategy, oversee CMOs/CDMOs, and ensure inspection readiness while collaborating with

Qualifications

• Ph.D. in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or related field.
• MS/BS with significant industry experience will be considered.
• 12+ years of biopharmaceutical or pharmaceutical development and manufacturing experience.
• Experience supporting late-stage clinical, registration, and commercial products.
• Analytical method development, validation, transfer, and lifecycle management experience.
• Experience authoring NDA, MAA, and global regulatory submissions.
• FDA and global health authority interaction experience.
• Experience managing CMOs, CDMOs, CROs, and external testing laboratories.

Responsibilities

• Develop and oversee analytical strategies for regulatory starting materials, intermediates, drug substance and drug product.
• Oversee all analytical activities at CMOs, CDMOs, CROs, and external labs.
• Review method development reports, validation protocols, validation reports, analytical procedures, and transfer reports.
• Establish analytical control strategies supporting product quality, process robustness, and regulatory compliance.
• Collaborate with Drug Substance and Drug Product teams to establish IPC strategies.
• Develop and oversee stability strategies and studies; ensure compliance with global regulatory requirements.
• Author analytical sections of global regulatory documents.

Skills

Analytical strategy

Regulatory submissions

Vendor management

Cross-functional leadership

Education

Ph.D. in Analytical Chemistry

MS/BS with significant industry experience

Job description

Celea Therapeutics, Inc. is seeking an experienced, strategic, and hands-on Associate Director/Director, Analytical Steward, CMC to serve as the end-to-end technical owner for analytical activities across the product lifecycle.

Based in Boston, this hybrid role drives phase-appropriate development, regulatory submissions, and lifecycle management for drug substances and products. You will lead analytical strategy, oversee CMOs/CDMOs, and ensure inspection readiness while collaborating with