Senior Biologics Analytics Lead – Late-Stage Development

Hemab Therapeutics; København; In loco; DKK 1.000.000 - 1.350.000; Tempo pieno

Descrizione del lavoro

Hemab Therapeutics in Copenhagen is seeking a Principal Scientist to lead Analytical Development for biologics, spanning early- to late-stage programs. You will drive method development, validation, and CMC readiness, coordinating with CDMOs and cross-functional teams to ensure regulatory compliance and commercial readiness.

The role requires 7+ years in biologics analytics, strong collaboration, and excellent communication for regulatory documents.

Competenze

• Bachelor’s degree in a relevant subject with advanced degree preferred.
• 7+ years of industry experience in analysis of biologics, especially late-stage.
• Experience with CDMOs and regulatory submissions (BLAs/MAAs) is required.

Mansioni

• Lead analytical development strategies for biologics across stages.
• Coordinate with CDMOs and internal teams for method development, validation, and specifications.
• Prepare and review CMC sections for regulatory submissions (BLAs/MAAs).
• Oversee transfer and validation of analytical methods with external partners.
• Drive continuous improvement by monitoring regulatory trends.

Conoscenze

Project management

Regulatory writing

Communication

Collaboration

Adaptability in biotech environments

Formazione

Bachelor’s degree in a relevant subject (analytical chemistry, protein chemistry, chemistry, biochemistry, biotechnology)

Master’s degree or Ph.D. preferred

Descrizione del lavoro

Hemab Therapeutics in Copenhagen is seeking a Principal Scientist to lead Analytical Development for biologics, spanning early- to late-stage programs. You will drive method development, validation, and CMC readiness, coordinating with CDMOs and cross-functional teams to ensure regulatory compliance and commercial readiness.

The role requires 7+ years in biologics analytics, strong collaboration, and excellent communication for regulatory documents.