Senior Biologics Analytical Development Scientist

Hemab Therapeutics; København; On-site; DKK 900,000 - 1,300,000; Full time

Job summary

Hemab Therapeutics is seeking a Principal Scientist in Analytical Development to lead late-stage analytical strategies for biologics, including method validation, characterization, and CMC contributions for BLAs/MAAs. You will manage external CROs/CDMOs and collaborate with cross-functional teams to ensure commercial readiness.

Ideal candidate has 7+ years in biologics analytics, strong regulatory experience, and a track record of efficient, compliant method development and transfer in a

Qualifications

• 7+ years of experience in biologics analysis, late-stage focus.
• Strong collaboration with CDMOs and external partners.
• Experience with regulatory submissions (BLAs/MAAs) preferred.

Responsibilities

• Lead analytical development strategies for biologics in late-stage programs.
• Coordinate analytical method transfer and validation with CROs/CDMOs.
• Prepare CMC sections for regulatory submissions (BLAs/MAAs).
• Represent analytical function in interactions with regulatory authorities.
• Drive continuous improvement and cost-efficiency in analytics.

Skills

Project management

Regulatory writing

Biologics analysis

Collaboration

Education

Bachelor's degree in a relevant field

Master's degree or PhD preferred

Job description

Hemab Therapeutics is seeking a Principal Scientist in Analytical Development to lead late-stage analytical strategies for biologics, including method validation, characterization, and CMC contributions for BLAs/MAAs. You will manage external CROs/CDMOs and collaborate with cross-functional teams to ensure commercial readiness.

Ideal candidate has 7+ years in biologics analytics, strong regulatory experience, and a track record of efficient, compliant method development and transfer in a