Drug Development Lead
22 hours ago
As a Drug Development Lead - Clinical Manufacturing at UCB, you will play a key role in supporting the definition and implementation of the external Drug Substance (DS) & Drug Product (DP) clinical manufacturing strategy for New Chemical Entity (NCE) drug substances and drug products.
About the RoleYou will lead the knowledge and technology transfer of manufacturing processes to external Contract Manufacturing Organizations (CMOs) and oversee clinical manufacturing activities to ensure successful batch production.
With a strong background in NCE/ NBE drug development and/or manufacturing, you will have excellent knowledge of cGMP and regulatory requirements. You will collaborate closely with line management, Subject Matter Experts (SMEs), project teams, Technical Solutions Teams, External Manufacturing Operations, Clinical Supply Teams, Quality Assurance, and other stakeholders to ensure seamless project execution.
Responsibilities- Lead the knowledge and technology transfer of manufacturing processes to external CMOs.
- Oversee clinical manufacturing activities at CMOs and ensure successful batch production.
- Act as the first point of contact for technical aspects of clinical manufacture.
We are looking for candidates with a minimum of 5 years of experience in NCE/NBE drug development and/or manufacturing. A good understanding of cGMP and regulatory requirements is essential. The estimated salary for this role is $120,000 - $150,000 per annum, depending on location.
The ideal candidate will be able to demonstrate excellent communication and leadership skills, with the ability to work effectively in a fast-paced environment. If you are a motivated and strategic thinker with a passion for clinical manufacturing, we encourage you to apply.
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