Hobson Prior is seeking a Plasmid Product Development CMC Scientist and Digital Enabler. This role focuses on compiling Quality by Design and regulatory dossier information, enabling internal department digital improvement initiatives, and providing project coordinator support for CMC project teams.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities

• Run small Expert Teams to compile Quality by Design and regulatory dossier information.
• Compile CMC regulatory dossier information & PACMP protocols/reports.
• Enable/direct internal department digital improvement initiatives encompassing: interactive training material, global portals, project reporting tools and dashboards, process flow data mapping.
• Provide project coordinator support for CMC project teams and internal department improvement and strategy/innovation initiatives.

Requirements

• Experience in the pharmaceutical industry (plasma, recombinant molecules, cell & gene therapy) or other high technology areas (MedTech, electronics).
• Project coordination/leadership skills.
• Knowledge of QbD, process development, scale-up, technology transfer, process validation, CMC regulatory affairs, and/or MS&T.
• Digital expertise with hands-on experience focused on advanced data management/data processing/data analytics in a life sciences area.
• Ability to interpret, visualize and communicate complex project data to facilitate collaborative decision-making driving cross-functional business outcomes.
• Knowledge of regulatory activities and trends, experience with health authority, i.e., FDA, EMA, PDMA.
• Excellent English communication skills, both spoken and written.
• German language skills are an asset.

Apply now

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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