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Manufacturing Associate

Marin Metro Area, CA

Posted: 10/08/2019 Job Type: Scientific Job Number: JN -102019-25773

DUTIES:

Shift: Sunday-Wednesday 7am-6pm


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


SKILLS:

Operate large scale bioprocess equipment for the cell culture and purification processing

Perform all aspects of processing with a broad understanding of science, compliance and technical aspect

Display competency with process equipment and automated control systems

Perform cleaning and sterilization of parts and equipment used with manufacturing process

Broad knowledge of biotech manufacturing process and equipment including cell culture, depth and tangential flow filtration, column chromatography, protein purification and formulation

Ability to understand, apply, and evaluate basic chemistry, biology and scientific principles as appropriate for the position

Proficiency with compliance; adherence to standard operating procedures, batch record, good documentation practices and data capturing


EDUCATION:

Bachelor s degree in science related area or engineering or Associate s degree in science related area or Biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry

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