Senior Director, Analytical Development CMC

Centessa Pharmaceuticals; Boston (MA); On-site; USD 180,000 - 230,000; Full time

Job summary

Centessa Pharmaceuticals seeks a Senior Director of Analytical Development within its CMC group to lead analytical strategies for small molecule drug substances and oral solid dose forms across development stages. The role emphasizes cross-functional leadership, external vendor management, and regulatory support.

The candidate will oversee method development, validation, and transfer at CDMOs, ensuring data integrity for regulatory filings and cGMP compliance, while collaborating with Quality

Qualifications

• PhD in chemistry or pharmaceutical sciences, strongly preferred.
• 10+ years in small molecule pharma with focus on analytical development.
• Experience with GMP validation and managing outsourced analytical activities.

Responsibilities

• Lead analytical strategies for small molecule drug substances and solid oral doses across development stages.
• Direct method development, validation, and transfer at external CDMOs.
• Ensure regulatory filings data quality and compliance with cGMP and global standards.
• Collaborate with Quality and project management to support IND through registration activities.

Skills

Analytical development

Vendor management

Regulatory documentation

Cross-functional leadership

Education

PhD in Chemistry or Pharmaceutical Sciences

Job description

Role: Senior Director of Analytical Development within Centessa's CMC group, responsible for leading analytical strategies for small molecule drug substances and solid oral doses across development stages.

Responsibilities

Responsibilities include directing method development, validation, and transfer at external CDMOs, overseeing analytical data for regulatory filings, and ensuring compliance with cGMP and global regulatory standards. This role serves as a technical expert in characterization, stability, and impurity profile, supporting IND through registration activities, and collaborating with cross-functional teams including Quality and project management.

Qualifications

PhD in chemistry or pharmaceutical sciences (strongly preferred), 10+ years in small molecule pharma, extensive experience in early-phase analytical development, GMP validation, and managing outsourced analytical activities. Expertise in physical/chemical characterization, stability studies, and regulatory documentation is essential.

High-Value

Small molecule oral solid dose, early to late development stages, cGMP compliance, global regulatory support, leadership in analytical strategy, and external vendor management.

Work setup

US-based, full-time, with occasional international travel.