Senior API Process Chemistry Manager: Tech Transfer & CMC

Insmed; New York (NY); On-site; USD 127,000 - 166,000; Full time

Job summary

Insmed is seeking a Senior Manager overseeing API manufacturing at contract manufacturing organizations, coordinating tech transfer, scale-up, and process optimization for clinical and commercial products. You will collaborate across regulatory, quality, and operations to shape CMC strategy, ensure adherence to cGMP, and review process documentation while supporting the commercial portfolio.

This role requires a PhD or equivalent experience and strong cross-functional leadership across global

Qualifications

• PhD in chemistry or chemical engineering or equivalent with API manufacturing experience.
• 2+ years implementing manufacturing tech improvements in regulated environments.
• Experience collaborating with CMOs and managing scale-up activities.
• Knowledge of quality systems, validation principles, and statistical process control.
• Understanding of CMC drug substance filings and cGMP.
• Strong verbal and written communication in multidisciplinary teams.
• Background in new chemical entity synthesis or physical organic chemistry preferred.

Responsibilities

• Oversee API and intermediate manufacturing at CMOs including tech transfer and scale-up.
• Drive process optimization and validation while ensuring continued manufacturing refinement.
• Provide technical expertise and review quality documentation for process improvements.
• Support commercial product portfolio with periodic technical assistance.
• Collaborate across regulatory, quality, and operations teams on CMC development strategy.

Skills

API manufacturing

Process development

Tech transfer

Scale-up operations

Quality systems

Validation principles

Statistical process control

cGMP regulatory filings

Regulatory collaboration

Communication

Education

PhD in chemistry or chemical engineering

Master's degree with 3+ years API manufacturing process development experience

Job description

Insmed is seeking a Senior Manager overseeing API manufacturing at contract manufacturing organizations, coordinating tech transfer, scale-up, and process optimization for clinical and commercial products. You will collaborate across regulatory, quality, and operations to shape CMC strategy, ensure adherence to cGMP, and review process documentation while supporting the commercial portfolio.

This role requires a PhD or equivalent experience and strong cross-functional leadership across global