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Manufacturing Associate in Novato, CA at Apex Life Sciences

Date Posted: 11/27/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Novato, CA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    11/27/2018
  • Job ID:
    890544

Job 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:

  • 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

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.


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:

  • Bachelors 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

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




890544