* Provide Technical Support for the commissioning and qualification of the drug substance manufacturing process.
* Work with site support groups to deliver qualified raw materials and consumables for the manufacturing process.
* Support the technology transfer of drug substance manufacturing process through effective collaboration with business partners and customers.
* Author, review and approve manufacturing documentation associated with transferred processes.
* Troubleshoot manufacturing issues and lead investigations through scientific problem-solving approaches.
* Partner with quality groups to support change management for the manufacturing process.
* Generate study plans, protocols and summary reports to support the manufacturing process.
* Establish and lead implementation of the continued process verification program to effectively manage product life cycles.
* Adherence to highest standards for Compliance (Quality and Safety)
* Ensure compliance with site EHS policy, cGMP and other business regulations and participate in risk assessments, audits, regulatory inspections and incident investigations.
* Actively participate in a culture of Continuous Improvement and process optimisation by deploying Six Sigma tools.
* Ensure the highest Quality, Compliance and Safety standards by participating and complying with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.
* BSc Biochemistry, Microbiology, Chemistry, Engineering or a related field
* 2 years experience in a pharmaceutical or a highly regulated environment preferably with cGMP experience
* Experience in at least two of the following areas protein chemistry, process engineering, cell culture, purification technologies, process operations, statistics, technology transfer, microbiological control of bio-manufacturing processes, cleaning validation, process validation, regulatory inspections.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
Fastnet - The Talent Group
'Not Just Placers.........Partners'
The Life Science Specialists