Senior CMC Analytical specialist

Senior CMC Analytical specialist

Genmab

Copenhagen, Denmark

Late Stage Manufacturing Development is responsible for the late-stage development activities of Genmab’s portfolio projects and preparation of the CMC package for regulatory filings. As the (senior) analytical specialist, will work across project teams to support the project managers and work closely with other specialists e.g. upstream processing, downstream processing, and characterization as well as external stakeholders.

Key Responsibilities include:

• Development and implementation of the LSMD analytical and characterization strategy for ongoing projects
• Day-to-day oversight of characterization activities performed at Genmab partnered CMOs and internal Genmab laboratories
• Prepare and review technical documents and author regulatory submission documents
• Collaborate with other areas to develop late-stage analytical/characterization strategies and refine required processes

Requirements:

• Master's degree in science, pharmacy, or a related technical area; advanced degree or certification preferred
• Minimum of 8 years of experience in CMC or a related area within the pharmaceutical or biotechnology industry
• You have a thorough understanding of the detailed requirements for analytical validation and requirements for small-molecule/peptide analytics
• Ability to author and review documentation for regulatory market authorizations (e.g., BLA, MAA)
• Excellent communication skills in English (both written and oral) and the ability to work in multicultural teams

Professional Qualities:

• Goal-oriented with a focus on achieving outcomes important to the team and organization
• Proactive, taking initiative and responsibility in a fast-paced environment
• Strong ability to work under pressure with tight timelines
• Team player capable of collaborating with a diverse group of internal and external stakeholders