Job Description

Title: Manufacturing Associate

Location: Novato, CA

Duration: 6+ Months

Category: Manufacturing / Production / Operations Job Title: Manufacturing Associate

Duties: Shift: Thursday through Saturday and alternating Wednesday's 0600-1900

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: 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 Compliances: 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

#TB_PH

Job Tags

Shift work, Saturday,

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