Manufacturing Associate - 2nd Shift in Novato, CA at Apex Life Sciences

Date Posted: 6/6/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Novato, CA
  • Job Type:
    Manufacturing
  • Experience:
    Not Specified
  • Date Posted:
    6/6/2018
  • Job ID:
    855619

Job Description


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

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:

  • Bachelors degree in science related area or engineering or 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 employeeservices@apexsystemsinc.com or 844-463-6178.