Senior Director, Analytical Development – CMC (Small Molecules)

Centessa Pharmaceuticals; Boston (MA); On-site; USD 165,000 - 250,000; Full time

Benefits offered by this job

401(k) plan

Medical/dental/vision insurance

Life insurance

Generous paid time off

Wellness program

Job summary

Centessa Pharmaceuticals, a Boston-based company, is seeking a Senior Director of Analytical Development to lead phase-appropriate analytical strategy across CDMOs for drug substance and product development. You will drive method development, qualification, and stability programs for small molecules, ensuring cGMP compliance and timely regulatory submissions.

The role requires 10+ years in small molecule analytical development, a PhD preferred, and strong leadership across cross-functional

Qualifications

• Hands-on development and validation of raw material, in-process, drug substance, and drug product methods.
• Experience with cGMP and global regulatory expectations for small molecules.
• Ability to manage outsourced analytical activities at CDMOs and drive regulatory submissions.
• Lead method development, qualification/validation, and stability programs.

Responsibilities

• Lead analytical strategy for phase-appropriate method development and product characterization.
• Oversee CDMO transfer and qualification activities for drug substance and drug product analytics.
• Review validation protocols/reports and test data for release, stability, and characterization.
• Generate stability data tables and support expiry and shelf-life assignments.
• Set specifications based on historical data and analytical results.
• Represent analytical CMC on program teams and mentor junior staff.
• Contribute to regulatory filings with material justifications and dissolution development.
• Collaborate with Quality on OOE/OOT/OOS investigations and deviations.
• Participate in batch record review across programs.

Skills

Analytical development

cGMP

Regulatory guidance

CDMO management

Stability programs

DS/DP characterization

Project management

Cross-functional leadership

Education

PhD in chemistry/pharmaceutical sciences

Job description

Centessa Pharmaceuticals, a Boston-based company, is seeking a Senior Director of Analytical Development to lead phase-appropriate analytical strategy across CDMOs for drug substance and product development. You will drive method development, qualification, and stability programs for small molecules, ensuring cGMP compliance and timely regulatory submissions.

The role requires 10+ years in small molecule analytical development, a PhD preferred, and strong leadership across cross-functional