Process and Analytical Development Technical Specialist is required for a global Biopharmaceutical company in Cork. The facility specialises in the fermentation, purification and sterile filling of biotech products, as well as supporting product development and clinical trials. The site has recently received significant investment to increase the onsite capabilities and has a significant European role in this global organization. The Site mission is “to be a globally competitive BioPharma site with proven capability, excellence in compliance, and flawlessly supplying products that meet customers’ expectations”.
The Process and Analytical Development Technical Specialist will be responsible for:
o Good knowledge of protein chemistry and analytical techniques such as HPLC, SDS-PAGE, IEF, CE, ELISA and general compendial methods.
o Perform laboratory experiments required to deliver on project timelines
o Participate in continuous improvement initiatives, including method optimisation and troubleshooting
o Support small scale process optimisation activities
o Preparation of documentation associated with the projects in accordance with GDP (good documentation practice) and site procedures.
o Lead and Participate in cross-functional problem solving teams for troubleshooting, and investigations within API, Sterile and Quality functions
o Qualification of laboratory equipment and small scale process equipment
oPrepare, review and approval of technical documents, procedures, CAPAs, change control, deviations, metrics, etc.
The Process and Analytical Development Technical Specialist requires:
o MSc/BSc. qualification (Science)
o At least 3 years’ experience in an analytical/ small scale process development role in QC or an analytical/process development group.
o Desirable: Project management qualification such as, Project Management Professional (PMP) Evidence of Continuous Professional Development.
Call Amparo in LSC on 021 4777 329 to discuss this new Process and Analytical Development Technical Specialist role in more detail or apply directly via this advert.