Director, CMC Analytics — Remote Analytical Leader

NewAmsterdam Pharma Corporation; Massachusetts; Hybrid; USD 180,000 - 240,000; Full time

Job summary

NewAmsterdam Pharma seeks a Director, CMC Analytical to lead analytical development strategy across API/DP, supporting clinical and late-stage programs, regulatory submissions, and lifecycle management. Reports to the ED, Analytical Development.

This role oversees testing methodologies, stability programs, regulatory documentation, and collaboration with CDMO and cross-functional teams. Travel may be required domestically or internationally.

Qualifications

• PhD in analytical chemistry or related field; 12+ years of analytical team leadership in biotech/pharma.
• Experience managing relationships with contract manufacturing organizations.
• Experience in early and late-stage programs, commercialization, and lifecycle management.

Responsibilities

• Spearhead strategic direction for analytical development and quality control across API/DP.
• Provide technical leadership for analytical development, methods, and testing at CDMO.
• Oversee testing methodologies, specifications, and stability programs for APIs and DP.
• Support regulatory approval, commercial launch prep, process validation, and lifecycle management.
• Oversee API/DP release and stability testing and regulatory documentation.

Skills

Interpersonal skills

Negotiation

Communication

Analytical skills

Project management

Education

PhD in analytical chemistry or related field

Job description

NewAmsterdam Pharma seeks a Director, CMC Analytical to lead analytical development strategy across API/DP, supporting clinical and late-stage programs, regulatory submissions, and lifecycle management. Reports to the ED, Analytical Development.

This role oversees testing methodologies, stability programs, regulatory documentation, and collaboration with CDMO and cross-functional teams. Travel may be required domestically or internationally.