Biomanufacturing Associate/Operations Specialist

Job Title: Biomanufacturing Associate/Operations Specialist

Duration: 12 months of contract with possible extension/conversion

Location: Irvine, CA US 92612

Job Duties

Performs functions associated with cGMP biologics manufacturing operations within the production facility, including working with other operations personnel in equipment set-up and batch processing. Uses 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. Works with Quality, Maintenance, Warehouse, Documentation and Materials Management departments to execute the production plan. Assists in developing procedures to control or modify the manufacturing process.

Responsibilities

Cell culture (from vial thaw to production scale).

Column chromatography.
Tangential flow filtration
Sampling of in process and raw materials.
Running glass washer / autoclave.
Buffer / media preparation.
Equipment preparation (CIP / SIP).

Maintaining inventory levels.

Qualifications

• Bachelor s Degree or equivalent required.
• At least 2-5 years relevant experience with good writing skills and computer skills.
• Working knowledge of media/buffer preparation, cell culture or purification of biological drugs is required.
• Working knowledge of safety, quality systems, and cGMPs is required
• Completes tasks in resourceful and effective ways.
• Applies knowledge, experience, and technical skills to understand production objectives, to provide support to production initiatives, to execute procedures efficiently and compliantly, and use standard practices to ensure inter-group consistency.
• Works on problems of moderate complexity, where analysis of situations requires evaluation of several factors.
• Works with management and senior staff to determine appropriate course of action within defined procedures.
• Coordinates activities of sub-group and actively works with other sub-groups. Frequently interacts with supervisor