2 positions – both 11 month contracts.
The Vaccines Operations team are currently recruiting for a Technical Specialist to provide Technical expertise to the manufacturing team. This role will report to a Process Lead, V116 Operations team. The Technical Specialist will demonstrate a high level of innovation, enthusiasm and drive to deliver technical excellence for characterisation and optimisation of manufacturing processes and will be accountable for providing scientific and technical support to the operations team for effective and efficient running of all operations activities to a defined daily, weekly and monthly schedule as agreed with our customers. This requires a flexible, collaborative, and coaching style and will require a substantial amount of their time within the IPT process, engaging and communicating with all IPT members.
• 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 company 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 Degree in Biochemistry, Microbiology, Chemistry, Engineering or a related field.
• 1-3 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.
• Evidence of Continuous Professional Development and cross skilling.
This is a 6 month contract role. Responsibilities: • Provide significant technical expertise to support all aspects of the manufacturing...Apply For This Job
Purpose: This is 2 cycle shift. 20% shift allowance. This is an 11-month contract initially. We seek a QC Technician...Apply For This Job
Purpose: Process Sciences is a technical services department that deals with a range of scientific, technical, engineering and mathematical needs...Apply For This Job
Purpose: This is an 11-month contract. Responsible for providing process, technical, and validation support operations including ongoing support of manufacturing...Apply For This Job
Purpose: This is an 11 month contract position. Key Process Engineer in the commercial products engineering team to address and...Apply For This Job
Purpose: Supports the Process Sciences Department through small scale laboratory experiments, as well as analysis, troubleshooting, and validation of manufacturing...Apply For This Job