Senior Manager, Process Chemistry

Insmed; Williamstown (NJ); On-site; USD 127,000 - 166,000; Full time

Job summary

Insmed seeks a Senior Manager to oversee active pharmaceutical ingredient manufacturing at CMOs, directing tech transfer and scale-up for clinical and commercial products. The role focuses on process optimization, validation, and cross-functional CMC strategy.

You will collaborate with regulatory, quality and operations teams to advance the portfolio and ensure compliant product development and manufacturing.

Qualifications

• PhD in chemistry or chemical engineering or a related field with API manufacturing experience.
• Experience implementing global CMO tech transfer and scale-up efforts.
• Strong understanding of cGMP, quality systems and regulatory expectations.

Responsibilities

• Oversee API and intermediate manufacturing at CMOs, including tech transfer and scale-up.
• Drive process optimization and validation to continuously refine manufacturing.
• Provide technical review of quality documentation for process improvements.
• Support commercial product portfolio with periodic technical assistance.
• Collaborate with regulatory, quality and operations on CMC strategy.

Skills

Tech transfer

Process optimization

Quality systems

Statistical process control

Cross-functional collaboration

Education

PhD in chemistry or chemical engineering

MS in related field with 3+ years API manufacturing

Job description

Senior Manager overseeing active pharmaceutical ingredient manufacturing at contract manufacturing organizations, managing tech transfer, process optimization, and CMC strategy for clinical and commercial products.

Responsibilities

• Oversee API and intermediate manufacturing at CMOs including tech transfer and scale-up operations
• 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

Requirements

• PhD in chemistry or chemical engineering, OR Master's degree with 3+ years API manufacturing process development experience
• 2+ years implementing pharmaceutical manufacturing technology improvements in regulated environments
• Experience collaborating with CMO operations and managing manufacturing scale-up activities
• Knowledge of quality systems, validation principles, and statistical process control
• Understanding of CMC drug substance regulatory filings and cGMP requirements
• Strong verbal and written communication with ability to work in multidisciplinary teams
• Background in new chemical entity synthesis or physical organic chemistry preferred

Compensation: $127,000-$165,500 annual