Research & Development
Principal Scientist – Analytical Development
Resumé
The Principal Scientist will lead analytical development for biologics across early- and late-stage programs, working with external partners on methods, validations, characterization, and regulatory submissions.
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Kort om jobbet
About Hemab Hemab is a clinical-stage biotech company on a mission to develop innovative treatments for neglected bleeding and thrombotic disorders. With sites in Copenhagen and Boston, we combine high-impact science with a collaborative culture as we progress toward commercialization.
Position Summary We are seeking a Principal Scientist to fill a specialist role in Analytical Development with strong experience in the analysis of biologics to support late-stage activities, including method validations/Quality Control activities to support commercial readiness, setting and justifying specifications, process and product characterization, and preparing CMC sections in regulatory submissions (BLAs/MAAs).
You will play a key role in driving analytical development strategies and managing analytical activities at multiple CROs/CDMOs. This position spans both early- and late-stage development, ensuring smooth progression from clinical manufacturing to commercial readiness.
Key Responsibilities Early-Stage Analytical Development - Support early-stage biologics programs by applying phase-appropriate strategies for analytical development. - Collaborate with Drug Substance, Drug Product, Research, Quality, and Regulatory teams to align on required analytical support1 …
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