Sunday, February 16, 2020 6:50:08 AM
JOB VACANCY: Clinical Co-ordinator
The Clinical Coordinator is responsible for facilitating the relationship between Advent BioServices manufacturing team, the client, blood collection centres and couriers.
You will work closely with GMP Production Scientists and Quality Assurance staff and facilitate the efficient delivery of cellular therapy products for clinical use. They will ensure that appropriate guidelines are available to third party sites and that appropriate documentation, such as virology screening and patient consent, is received to allow manufacture of products. The post holder will visit UK clinical sites if required and provide support and training to hospital clinical teams.
As Clinical Coordinator you will demonstrate a pro-active autonomous approach with strong communication skills.
Key responsibilities for this role:
• Scheduling and communication for patients and the manufacturing team
• Working with the Manufacturing Team and the Quality Team to ensure that the procurement, manufacture, transportation and storage of tissue and cells is compliant with HTA and MHRA regulations
• Ensuring that contracts with all relevant stakeholders required for the manufacture process are in place, such as SLAs and MTAs
• Provide training to Apheresis collection centres, administration centres and couriers to ensure that tissues and cells are handled and transported in the correct conditions and in a safe manner
https://www.adventbio.uk/job-clinical-coordinator
JOB VACANCY: Validation Lead Scientist.
We are looking for a GMP experienced validation/qualification professional to progress their careers with us in the exciting area of cell & gene therapies. As Validation Lead you will work across GMP manufacturing, Quality Control laboratory facilities and the Cryostorage facility to ensure that all aspects of validation comply with relevant regulations.
Key responsibilities for this role:
• To support validation activities including equipment, facilities, processes and cleaning. This will include cleanrooms, medical gas supply and computer systems including environmental monitoring systems
• To co-ordinate validation/qualification and change control activities. Work with external contractors and supplies to ensure that a schedule is maintained, reports written on time and related documents kept current
• To agree scope of validation activities in line with company and regulatory requirements
• Author/approver of validation lifecycle documentation and reviews
• To internally promote validation activities, prepare training material and carry out in-house training in validation
• To support audits and inspections including inspections from regulatory bodies
https://www.adventbio.uk/job-validation-lead-scientist
Pilar Velasco Sevillano.
GMP Production Scientist at Advent Bioservices
Cambridge, United Kingdom
https://www.linkedin.com/in/pilar-velasco-sevillano-22026a55/
Luissana Vidal
GMP Production Scientist at Advent Bioservices
London, Greater London, United Kingdom
https://www.linkedin.com/in/luissana-vidal-916b26bb/
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