Biopharmaceutical Manufacturing Production Specialist

1 week ago


Berkeley, California, United States Randstad Life Sciences US Full time
Job Title: Manufacturing Production Specialist

Location: Berkeley, CA

Schedule: 1st shift (6am-3pm), 2nd shift (1-10pm), 3rd shift (9:30pm-6:30am)

Position Type: 18 mo. contract through Jan. 2026; potential for extension

We are seeking highly skilled Manufacturing Production Specialists to join our team at a multinational, biopharmaceutical company in Berkeley, CA. This role will support clinical production and involve cell culture/expansion and purification.

Key Responsibilities:
  • Prepare process equipment, including bioreactors, stainless steel tanks, and ancillary equipment.
  • Clean and sterilize equipment using CIP and SIP procedures.
  • Perform daily process operations in cell culture and purification of biotech and biological products.
  • Operate equipment for processes, including inoculation and monitoring of bioreactors, processing cTCF material, and operating chromatography and TFF skids.
  • Process MAEF material using closed thaw process, step elution chromatography, membrane absorber and filter clearance technology, and gradient controlled SP column separation techniques.
  • Operate automated bagging systems and blast freeze product for storage.
  • Dispense chemicals and formulate solutions, prepare acids and bases as necessary, and perform aseptic operations.
  • Take, analyze, and submit samples as required throughout the process.
  • Monitor and control operation with computer control systems and complete routine check sheets.
  • Clean equipment and maintain clean and orderly production facilities.
  • Perform in-depth troubleshooting and root cause analysis of equipment and process failures.
  • Contribute to continuous improvement opportunities and perform all operations in compliance with cGMP.
Requirements:
  • BS in science related field preferred.
  • Completion of two-years' college science courses in biology, chemistry, biochemistry, or microbiology, or a certificate from an accredited bio-technology academy.
  • Relevant bio-tech industry experience in cell culture bioreactor system assembly and use, continuous cells separation equipment preparation and process/controls, membrane absorption chromatography process, and basic knowledge of protein chemistry and purification systems.
  • Familiarity with cGMP's and applicable agency regulations.
  • Ability to lift 45 lb and work with highest level of flexibility, responding easily to last minute changes to production schedule.
Preferred Skills and Experience:
  • Experienced with data integrity, regulatory requirements for pharmaceutical manufacturing.
  • Experienced in operation of thermo SUM, 200L and 2000 bioreactors, Akta ready XL, Akta ready gradient, and Akta ready Flux XL.
  • Experienced with business IT systems and Microsoft Office, with excellent computer skills.


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