Opportunity for an experienced biotechnologist with prior experience in biologics facility to perform functions associated with cGMP manufacturing operations within the biologics production facility, including working with engineers in set-up and calibration tasks, as well as performing rework and quality testing related to the production of parts, components, and final materials.
Role:
· Responsible for Cell culture (from vial thaw to production scale), Buffer/ media preparation, column chromatography, tangential flow filtration and sampling of in process and raw materials.
· Use sophisticated programs (such as LIMS, SAP, automated control systems, etc.) to collect and evaluate operating data, which can be used to conduct on-line adjustments to products, instruments or equipment and determine and may assist in developing methods and procedures to control or modify the manufacturing process
· Assigns tasks within the shift team to other biotechnologists
· Assists Supervisor in planning and leading area activities to ensure adherence to schedule
· Involved in regulatory/internal audits and inspections, and in cross-functional meetings
· Initiates Demand Work Order, reviews executed batch records and worksheets
· Drives the resolution of anomalous processing events
· Sets a positive team environment and inculcates a nurturing culture
· Acting Supervisor when Supervisor is not available
Requirements
· Bachelor of Science with at least 4 years of experience working in Biologics Production facility or equivalent, of which at least 3 years spent in a specific area/stream experience
· As a highly skilled specialist, you will contribute to the development of concepts and techniques and completes complex tasks in creative and effective ways.
· Experienced working on complex assignments requiring independent action and a high degree of initiative to resolve issues.
· Makes recommendations for new procedures.
· Acts independently to determine methods and procedures on new assignments.
· Assists Supervisor in planning and leading area activities.
· Shift work is required
Interested applicants, please submit your profile to [email protected] for review. We will be in touch for initial discussion upon being shortlisted
EA Licence: 17S8795 | EAP: R1108333