Join a trailblazing biotech on the cutting edge of science and technology.

Hobson Prior is seeking a CMC Leader with expertise in drug product (DP) solids to join a biotech organization in Mechelen, Belgium. In this role, you will oversee the development and manufacturing of solid drug products, ensuring compliance with quality standards and regulatory requirements. You will work closely with external partners and internal teams to manage documentation, quality processes, and project deliverables.

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

Responsibilities:

• Organize, review, approve, and store key documents for clinical trial applications and regulatory submissions.
• Manage external service providers (ESPs) involved in drug product development and manufacturing.
• Review and approve technical documents such as protocols, reports, and batch records from ESPs, ensuring proper archiving.
• Collaborate with internal quality teams to ensure compliance with current Good Manufacturing Practices (cGMP).
• Maintain and update the Product Specification File.
• Ensure adherence to internal policies, procedures, and training requirements.
• Provide input on due diligence projects when needed.

Key Skills and Requirements:

• Advanced degree (master's or PhD) in chemistry, pharmaceutical sciences, bio-engineering, or equivalent experience.
• Expertise in solid formulation development and experience working with contract research organizations (CROs) and cross-functional teams.
• Strong communication, organizational, and interpersonal skills.
• Proven ability to lead meetings, technical discussions, and collaborative projects.
• Proficient in English, both written and verbal.
• Hands-on, pragmatic approach to problem-solving.

For more information, please contact Jessica Taylor.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists visit the 'Contact Us' 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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