Biopharmaceutical Manufacturing Associate

Job Description

Purpose: 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 of relevant experience with good writing 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, provide support to production initiatives, 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 an appropriate course of action within defined procedures
• Coordinates activities of sub-groups and actively works with other sub-groups
• Frequently interacts with supervisors

Job Types: Full-time, Contract

Pay: $25.00 - $30.00 per hour

Expected hours: 40 per week

Benefits:

• Dental insurance
• Health insurance
• Life insurance
• Vision insurance

Schedule:

• 8 hour shift

Education:

• Bachelor's (Required)

Experience:

• Clean room: 3 years (Required)
• GMP: 3 years (Required)
• SAP inventory tracking: 3 years (Required)
• LIMS/EBR (electronic batch records): 3 years (Required)
• Documentation/SOP: 3 years (Required)

Ability to Commute:

• Irvine, CA 92612 (Required)

Work Location: In person

Salary : $25 - $30