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Manufacturing Associate

Marin Metro Area, CA

Posted: 06/03/2019 Job Type: Scientific Job Number: JN -062019-25010
WORK ENVIRONMENT/PHYSICAL DEMANDS
  • Consists of strenuous, repetitive work. The following list of physical movements maybe used on a daily basis: bending, reaching, climbing stairs and ladders, kneeling and making numerous equipment connections using hands.
  • Independently have the ability to regularly lift, dispense, push and/or pull items with an average weight of 25 pounds.
  • May require work around loud equipment.
  • The use of personal protective equipment will be required.
  • Requires various shift based work and off hours
  • 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

Skills
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
  • 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
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
  • I have read and understand the Temp Guidelines


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