The role will provide expertise to support the technology transfer, process validation and routine commercial manufacturing for Upstream and/or Downstream manufacturing for a leading pharmaceutical company based in Dublin.
Responsibilities:
Providing process expertise in upstream (cell culture) and/or downstream (purification) disciplines.
Develop, review, and approve electronic batch records, process transfer documentation, and validation documents.
Identify and oversee laboratory studies to support process decisions and transfers.
Support the introduction of new raw materials and consumables.
Collaborate with Quality, Supply Chain, and Manufacturing Operations to ensure material availability.
Implement process improvements to reduce cycle time.
Lead plant support studies and technical studies at commercial scale.
Provide troubleshooting and resolving process issues.
Lead key process changes using the change control system.
Ensure compliance with EHS policies, cGMP, and other regulations.
Author and review regulatory submission documents.
Requirements:
A minimum of 3 years in Technical Services or Process Development.
Strong understanding of GMP requirements.
A minimum of 3 years experience in a pharmaceutical company.
Experience within Technology Transfer.
Seniority level Mid-Senior level
Employment type Full-time
Job function Manufacturing, Supply Chain, and Quality Assurance
Industries Pharmaceutical Manufacturing
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