Senior Scientist in Late-stage Downstream Development

Category: Research

Location:Bagsværd, Capital Region of Denmark, DK

• Participate in shaping and implementing the framework for the API process characterization activities, including selecting methodologies, tools, and analytical techniques and communicating this within our area.
• Participate in cross-functional project groups for aligning process characterization strategies across the CMC API Development & Scaling area.
• Close collaboration with MSAT in Product Supply to ensure a mutual understanding of the process and scale with our stakeholders and a smooth tech transfer.
• Select and use appropriate analytical tools such as statistical or mechanistic models.
• Be innovative in experimental design and optimization of API processes and workflows, identifying new solutions to increase robustness and/or capacity in the late-stage projects.
• Prepare and review sections for the CMC part of the regulatory submission files.
• Reporting and communication of your results to your peers, project and line management and our stakeholders.

• A Master’s degree in biochemistry, (bio-)chemical engineering, protein chemistry, or similar, along with some relevant industrial work experience.
• A positive mindset.
• A systematic approach and a drive to finalize your tasks in time.
• Good collaboration skills and good communication skills in English.

• Experience with process characterization.
• Experience in downstream process steps such as purification by chromatography, tangential flow filtration for UF/DF, modifications and supporting analytics.
• Experience with statistical methods (LHS and/or Do E), and potentially experience with mechanistic mathematical modelling and/or working with large data sets is an advantage.
• Experience with preparation of regulatory documentation.