Manufacturing Associate (Downstream Purification) in Novato, CA at Apex Life Sciences

Date Posted: 7/16/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Novato, CA
  • Job Type:
    Manufacturing
  • Experience:
    Not Specified
  • Date Posted:
    7/16/2018
  • Job ID:
    846627

Job Description


Duties:

  • 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 escalate processing issues and support solutions.
  • Gain experience with automation systems (LIMS, MES, PI, etc.).
  • 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.
  • Understanding of cGMPs as related to Commercial Operations Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.)
  • 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.
  • 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.

Skills:

  • Strong communication skills-verbal and written.
  • Ability to work in a team environment, which includes good conflict resolution and collaboration.
  • Displays good initiative to identify areas for improvement and implement solutions
     

Education:

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

Schedule Details: Swing Shift: M-F, 2pm-11pm