(Senior) Manager CMC Analytical Life Cycle
- Permanent
- Technical Operations, Discovery / R&D, Analytical
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Hobson Prior is seeking a Senior Manager for CMC Analytical Life Cycle. This role focuses on providing analytical expertise in the field of monoclonal antibodies/protein analytics. The successful candidate will collaborate with various teams to deliver analytical packages that meet global health authority standards.
Please note that to be considered for this role you must have the right to work in this location.
Key Responsibilities
- Provide expert knowledge in monoclonal antibodies/protein analytics to support product development.
- Collaborate with development teams, regulatory affairs, and quality functions to deliver analytical packages that meet project objectives.
- Work with experts to write and review analytical sections of health authority submissions, including Biologics License Applications and Marketing Authorization Applications.
- Support phase III development, biosimilar license application, and post-marketing activities, ensuring scientific rigor and data integrity.
Requirements
- Expertise in monoclonal antibodies/protein analytics.
- Knowledge of Good Laboratory Practice/Good Manufacturing Practice, ability to interpret guidelines and implement compliant analytical packages in highly regulated markets.
- Familiarity with Biologics License Applications/Marketing Authorization Applications filing and International Council for Harmonisation guidelines.
- Experience with analytics related to phase III development to licensed biopharmaceuticals, including product life cycle management and product maintenance biotech manufacturing operations.
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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