Upstream Cell Culture Associate II / III

BioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for an Upstream Cell Culture Associate II / III to work for a San Diego Area contract manufacturing company.
 
Upstream Cell Culture Associate II / III 
 
Description:

The Manufacturing Associate performs and documents daily manufacturing operations in a cGMP environment that involves operation of various process equipment, execution of protocols, creating/revising cGMP documents and other assignments. The candidate should be highly detail oriented with excellent documentation skills. Candidate will be trained in most or all unit operations in their area, often leading the execution of procedures, and performs with minimal supervision. The ideal candidate will have experience with aseptic technique, cell culture in flasks and bioreactors.  

Primary Responsibility:
Will be to execute GMP operations in a class 100,000 (ISO 8) and class 10,000 (ISO 7) clean rooms.

Essential:
  • Perform routine manufacturing activities of cell culture according to Batch Records, including product operations, line clearance, equipment processing, weigh and dispense operation, parts wash and autoclaving, buffer and media preparation and sample coordination. 
  • Demonstrate good aseptic technique.Operate and maintain manufacturing equipment, which includes but is not limited to bioreactors and controllers.
  • Author and revise manufacturing batch records and SOPs as needed to accurately reflect process steps as transferred from R&D/Client.  Able to write DR's, OOL's, OOS's etc.
  • Address production issues and participate in technical investigations in collaboration with quality, clients and quality teams.
  • Participate in cross functional activities to support process improvements, late-stage process characterization and process validation.
  • Must be able to work weekends, and flexible hours if required 
Job Requirements:
Education and Experience:
  • Bachelor’s degree in science or Engineering. 2-4 years' experience in the biotech/pharmaceutical industry. 
  • Associates degree acceptable with related experience.
  • Experience with bioreactors is a must.  Preferably more than 2 years with 10 L Glass bioreactors and 1000 L single use bioreactors.
  • Experience with mammalian cell culture
  • Detail understanding of cGMP and CFR-210 CFR-211 
Knowledge, skills and abilities:
  • Effective communication, teamwork skills and attention to details
  • Proficient with Microsoft Word and Excel
  • Ability to move of heavy equipment and the ability to lift ~50 pounds
  • Ability to work with pressurized systems, steam, and corrosive chemicals with necessary safety precautions.
 
If interested, please contact Gavin Lee at (562)495-3200 x4 or send him a copy of your most updated resume at gavin@biophaseinc.com. Please visit www.biophaseinc.com for additional jobs as well.
 
  • Location: San Diego
  • Type: Contract to Perm
  • Job ID: HS36417927