Our client is the leader in the field of biomedicines. Through the dynamic science of biotechnology, they continue to seek innovative ways to treat cancer, infectious diseases, cardiovascular and metabolic diseases, and immune-mediated inflammatory disorders.
In this role you will be representing operations on NPI tech transfers. You will be responsible for the delivery of NPI processes to the manufacturing site. You will have a strong experience in cell culture and harvest, viral inactivation, filtration, purification.
- Setup and lead project kickoff meetings, and other tech transfer meetings, as necessary, to coordinate efforts among BTDS for delivery of GMP clinical materials
- Investigate and resolve deviations raised within the manufacturing department, as needed
- Monitoring and reporting of process performance for supply chain and NPI tech transfers
- Act as the single point of contact (SPOC) between CMC and CSC teams / members and the Site Operations team, regarding tech transfer and GMP DS clinical supplies updates
- 5-10y of relevant working experience
- Experience with the following API manufacturing processes is required: cell culture and harvest, viral inactivation, filtration, purification
- Working knowledge of the following facility and site operations areas are required: facility design, HVAC, process utilities, room and equipment cleaning, and equipment qualification.
- Knowledge of cGMP’s and Agency requirements for biopharmaceutical manufacturing is required
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