Regulatory CMC Biologics Scientist - Hybrid US Role

Merck; Cambridge (MA); Hybrid; USD 140,000 - 200,000; Full time

Job summary

Scorpion Therapeutics in Cambridge, MA is seeking a Senior Scientist (R3) in Regulatory CMC Biologics to serve as project lead, developing and executing global regulatory strategies for biologics. Hybrid work with some travel is offered in the US.

Responsibilities include managing CMC documentation for INDs, BLAs, and variations; ensuring regulatory compliance; and assessing risks across the product lifecycle while collaborating with regulatory and development teams.

Qualifications

• 5+ years in Regulatory CMC with biologics experience preferred.
• BS in science or engineering; advanced degree preferred.
• Experience managing CMC documentation for INDs/BLAs and variations.

Responsibilities

• Lead development and execution of global regulatory strategies for biologics.
• Manage CMC documentation and regulatory submissions (INDs, BLAs, variations).
• Assess regulatory risks across product lifecycle and ensure compliance.

Skills

Regulatory affairs management

Documentation

Compliance

Communication with health authorities

eCTD proficiency

Education

Bachelor's degree in science or engineering

Job description

Scorpion Therapeutics in Cambridge, MA is seeking a Senior Scientist (R3) in Regulatory CMC Biologics to serve as project lead, developing and executing global regulatory strategies for biologics. Hybrid work with some travel is offered in the US.

Responsibilities include managing CMC documentation for INDs, BLAs, and variations; ensuring regulatory compliance; and assessing risks across the product lifecycle while collaborating with regulatory and development teams.