Job Title: Process Development Technician
Duration: 12 Months
Note: The role hours are 2:30pm-11:00pm with potential one hour overtime.
Must have purification process experience
Set-up and execution of cGMP unit operations with a focus on Purification (Chromotography, flow through filtration, tangential flow filtration) and solution formulation. Includes cleaning and sanitization of the facility and equipment (CIP, SIP, COP, autoclaving, depyrogenation, etc).
Accurately follow oral, written and electronic instructions in the production area and document daily operations in GMP batch records and logs.
Operate manual and automated equipment. Individuals will be expected to learn and work with enterprise system such as LabWare LIMS and SAP.
Support implementation of new technology for process execution and/or analysis. May be responsible for authoring and revising cGMP documents including batch records and SOPs.
Responsible for data entry and real time process monitoring.
Assist in inventory tracking, maintenance scheduling, and troubleshooting of mechanical equipment.
The Process Technician will be responsible for the execution of Purification, Buffer preparation and glasswash activities in a multi-product, multi-line cGMP facility capable of manufacturing commercial, clinical and development drug substance. Successful candidates will be flexible and adaptable, willing to work in a fast-paced, dynamic environment.
Years of Experience 3-5.
What is the minimum education experience required?
HS Diploma + 3 years of experience
Associate Degree + 1 year of experience