Senior Biologics Analytical Development Scientist

Hemab Therapeutics; København; Presencial; DKK 900.000 - 1.300.000; Jornada completa

Descripción de la vacante

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

Formación

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

Responsabilidades

• 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.

Conocimientos

Project management

Regulatory writing

Biologics analysis

Collaboration

Educación

Bachelor's degree in a relevant field

Master's degree or PhD preferred

Descripción del empleo

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