External Clinical Manufacturing Lead

External Clinical Manufacturing Lead

UCB - Union Chimique Belge

Braine-l'Alleud or Slough

About the Role

You will define and implement the overall external clinical manufacturing strategy for drug substances and drug products through various stages of development. You will be the primary point of contact for all technical aspects of clinical manufacturing and knowledge/technology transfer with external CMOs.

What You Will Do

• You will define and implement the overall external clinical manufacturing strategy.
• You will be responsible for the knowledge/technology transfer of manufacturing processes to external CMOs.
• You will manage clinical and stability batch manufacturing, ensuring on-time delivery.
• You will author and approve necessary documentation for knowledge transfer and clinical batch manufacturing.
• You will manage deviations and lead investigations and change controls related to transfer activities.
• You will coordinate the shipping of drug substances and products with Supply Leads.

Interested?

For this role, we are looking for the following education, experience, and skills:

• Bachelor's Degree or Master's Degree in pharmaceutical sciences or a related field.
• Minimum 5 years of experience in NCE/NBE drug development and/or manufacturing.
• Knowledge of NBE drug substance manufacturing/development and injectable dosage form manufacturing/development.
• Good knowledge of cGMP and regulatory requirements.
• Excellent communication, negotiation, and teamwork skills.
• Knowledge of analytical, preformulation, and formulation development is an advantage.

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