Senior Manager: Process Chemistry & CMC Strategy

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

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.