Director, CMC Analytics — Remote, Launch-Ready Leadership

NewAmsterdam Pharma Company; Boston (MA); Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

Health insurance

Dental & vision coverage

Term life and disability

Retirement plans

Annual bonus & long-term incentives

Job summary

NewAmsterdam Pharma Company seeks a Director, CMC Analytical to lead analytical development strategy for API and drug products across clinical and commercial programs. You will provide strategic and technical leadership for analytical development, quality control, and regulatory support, partnering with CDMOs and internal teams.

This remote role requires occasional in-person attendance at the Boston area office based on business needs; the company offers a competitive base salary, bonus, and

Qualifications

• PhD in analytical chemistry or related field with 12+ years in biotech/pharma leadership.
• Experience managing relationships with contract manufacturing organizations.
• Expertise in analytical method development, validation, stability for API/DP.
• Strong regulatory writing and dossier submission experience (INDs, NDAs).
• Excellent communication and leadership in fast-paced startup biotech.

Responsibilities

• Lead analytical development strategy for API and DP across lifecycle.
• Provide technical leadership to QC and regulatory support activities.
• Oversee testing methods, specifications, and stability programs.
• Contribute to regulatory filings and submissions.
• Collaborate with cross-functional teams (Regulatory, Quality, Supply).

Skills

Analytical leadership

Regulatory strategy

Project management

GMP knowledge

Communication skills

Education

PhD in analytical chemistry

Job description

NewAmsterdam Pharma Company seeks a Director, CMC Analytical to lead analytical development strategy for API and drug products across clinical and commercial programs. You will provide strategic and technical leadership for analytical development, quality control, and regulatory support, partnering with CDMOs and internal teams.

This remote role requires occasional in-person attendance at the Boston area office based on business needs; the company offers a competitive base salary, bonus, and