Job Description

Title: Manufacturing Associate

Duration: 12 Months Contract

Location: Novato, CA 94949 (Onsite)

Description:

Process Knowledge: Understanding of process theory and equipment operation

• Ability to learn biopharmaceutical manufacturing processes including mammalian cell culture, depth filtration, tangential flow filtration, column chromatography, protein purification and formulation of bulk drug substance
• Support initiatives for process optimization
• Identify and elevate processing issues and support solutions
• Demonstrated proficiency Gain experience with automation systems (LIMS, MES, PI, etc.)

Technical Documentation: Provide feedback and/or suggested changes to operational procedures

• Assist in the incorporation of new technologies, practices and standards into procedures
• Capable of writing and reviewing process documents

Quality and Compliance: Understanding of cGMPs as related to Commercial Operations

• Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.)

Business: Ability to participate on projects and contribute to outcomes

• Capability to learn and support new business systems (Track wise, ERP, etc.)
• Support trending of defined department metrics

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