Process Technician

SUMMARY:

- 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.

RESPONSIBILITIES:

- Set-up and execution of cGMP unit operations with a focus on chromatography column VRF, UF and final filtration operations, buffer preparation and glasswash.
- 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.

SKILLS:

QUALIFICATIONS:

- Associates Degree with 2+ years of experience, or an equivalent combination of education and experience is required.
- Experience working in a federally regulated environment is strongly preferred.
- Familiarity and experience with biotech cell culture, protein purification and/or support operations (such as solution preparation and/or operation of autoclave/depyrogenation ovens) preferred.
- Previous experience with manufacturing-scale bioreactors or harvest (centrifugation, depthfiltrations, microfiltration) a plus.
- Basic computer skills are required.
- Strong oral and written communications skills are desired.
- 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.
- MS Office.