CMC Analytics Director — Small Molecule Programs

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 and wellness program

Generous paid time off

Job summary

Centessa Pharmaceuticals seeks a Senior Director of Analytical Development within the CMC group. The role leads analytical method development, validation, and data strategy across programs and collaborates with drug substance and drug product teams.

Travel to vendors domestically and internationally is required. Familiarity with cGMP and regulatory expectations for starting materials, drug substances, and products is essential.

Qualifications

• Hands-on development and validation of analytical methods for raw materials, in-process materials, drug substances, and dosage forms.
• Experience with cGMP and regulatory expectations for starting materials, drug substances, and drug products.
• Proven track record in leading outsourced analytical activities at CDMOs.
• Strong leadership and mentoring of junior scientists.

Responsibilities

• Lead phase-appropriate method development, validation, and product characterization across programs.
• Oversee third-party method implementation, qualification/validation, and transfer for pre-IND through Registrational programs.
• Review validation protocols/reports and test data for release, stability, and characterization.
• Manage stability programs and data generation for expiry and shelf-life determinations.
• Serve as CMC analytical representative in project teams and regulatory filings.
• Coordinate with Quality on investigations and deviations related to analytical testing.

Skills

Analytical development

cGMP

Regulatory guidance

Leadership

Project management

CDMO coordination

Strategic thinking

Cross-functional collaboration

Problem solving

Education

PhD in Chemistry/Pharmaceutical Sciences

Job description

Centessa Pharmaceuticals seeks a Senior Director of Analytical Development within the CMC group. The role leads analytical method development, validation, and data strategy across programs and collaborates with drug substance and drug product teams.

Travel to vendors domestically and internationally is required. Familiarity with cGMP and regulatory expectations for starting materials, drug substances, and products is essential.