Reporting to the Senior Production Manager this position will be responsible for the culture and purification of raw material in the antibody manufacturing unit. The position would oversee the thaw, expansion and production batch culture of hybridoma cells and the creation of purified raw material alongside the replenishment of cell banks.
The role requires line management of the raw materials group and setting of the schedule based on available equipment and headcount.
This is a lab based position.
How You'll Make an Impact:
Scheduling of work activities, forward capacity planningOutput of purified antibody batches released under ISO9001 guidelinesLine management of 4 to 5 Technicians including Training and Development Process improvement guidance for projectsMeasurement and analysis of trends in the departmentProtocol updates, troubleshooting, equipment maintenanceWorking to ISO9001 guidelines and company procedures the role also requires batches to be released to QC, maintenance of equipment and monitoring of departmental KPIs. What You Bring:
Degree or equivalent in Life Science subjectMinimum 5 years' experience of culture/protein manufacturing in a commercial environment/organizationWorking knowledge of Quality Systems requirements, ISO, GMP, or similarProficient at troubleshooting and performing root cause analysis of process variance or failureA working/demonstrable knowledge of antibody manufacture from cell cultureCell culture background with experience in multiple techniques including stirred lab scale culture and automated bioreactors.Clone optimization and process development experience would also be essential preferably using techniques and equipment such as the AmBr250.Experience in authoring and updating SOPs.Able to extract, verify, compile and articulate information from a variety of sourcesAble to lead projects to improve manufacturing processesPeople management experience desirableA forward–thinking with a desire not only to learn but also to utilize knowledge to improve procedures and practices and be a great ambassador for positive change.Ability to deliver training in process and procedureTrain the trainer knowledge would also be desirable to ensure continued competency of the team. Cell Culture Bio Reactor Ambr250 Ambr150 Upstream USP Protein Purification GMP Good Manufacturing Practice ISO9001 Cell Banks Antibody Manufacturing SOP