Clinical Trial Associate

  • location: Novato, CA
  • type: Contract
  • salary: $19.34 - $22.75 per hour
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job description

Clinical Trial Associate

Manufacturing Associate

Job Responsibilities

  • 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.)
  • 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
Education & Qualifications

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

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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