Senior Manager, Process Chemistry

Scorpion Therapeutics; United States; Remote; USD 180,000 - 240,000; Full time

Job summary

Insmed is seeking a Senior Manager, Process Chemistry on the API Development team to oversee API/intermediate/RSM manufacturing at CMOs, including tech transfer, process optimization, and validation.

The role requires a PhD or Master’s with 3+ years in API process development/execution, plus experience with pharmaceutical manufacturing technology and regulatory compliance. Fully remote with ~10% travel domestically and internationally.

Qualifications

• PhD or Master’s with 3+ years in API process development/execution.
• Experience with pharmaceutical manufacturing technology and CMOs.
• Familiarity with regulatory compliance in pharma.
• Strong understanding of CMC documentation and validation principles.

Responsibilities

• Oversee scale-up and process improvements; act as SME for API/ intermediates and RSM manufacturing.
• Review quality documentation and support tech transfer to CMOs.
• Contribute to process refinement for clinical and commercial manufacturing.

Skills

API process

Tech transfer

Regulatory compliance

CMC documentation

Validation

Education

PhD in related field

Master's in related field

Job description

Role:

Senior Manager, Process Chemistry on the API Development team, responsible for managing API/intermediate/RSM manufacturing at Insmed’s CMOs, including tech transfer, process optimization, and validation.

Responsibilities:

oversee scale-up, process improvements, and provide technical support as SME; review quality documentation; contribute to process refinement for clinical and commercial manufacturing.

Requirements:

PhD or Master’s with 3+ years in API process development/execution; experience with pharmaceutical manufacturing technology, working with CMO operations, and regulatory compliance.

High-Value:

expertise in NCE synthesis, physical organic chemistry, CMC drug substance documentation, validation principles, and cGMP standards; preferred experience in marketed products across US, EU, JP.

Work setup:

fully remote with occasional domestic/international travel (~10%).