Job Title: Process Development Technician II
• 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.
• 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.
Education & Qualifications
• HS Diploma + 3 years of experience
• Associate Degree + 1 year of experience
• Daily routine may require moving heavy equipment, standing for long periods of time, and/or walking throughout the suite including up and down stairs.
• Must be able to lift ~50 pounds.
• Medical, Dental, and Vision Insurance
• 401K Plan with Company Match
• Life and AD&D Insurance