Skip to Main Content

Manufacturing Associate/Sr. Associate (Upstream - Cell Culture)

BioPhase Solutions
Orange County, CA
  • Posted: over a month ago
  • Full-Time
Job Description
BioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a Manufacturing Associate/Sr. Associate (Upstream – Cell Culture) to work for a leading Orange County area contract manufacturing company.
This role is a full-time, non-exempt position.
Salary: $50-85k depending on experience
Flexible schedule due to operations/scheduling.
  • Work overtime and weekends as necessary
  • Shift work: Sun-Wed or Wed-Sat, 4 days x 10 hours
  • Operate and maintain cell culture bioreactors (100L - 2000L stainless steel and disposable STR/SUB) in batch, fed-batch, and perfusion modes
  • Perform equipment cleaning and sterilization manual cleaning, clean in place (CIP), pressure test (PT), and steam in place (SIP)
  • Responsible for cell culture expansions and aseptic techniques (thaw cell banks -1mL vial through cell culture expansion and maintenance - up to 36L spinner flasks performed in a BSC)
  • Operate and maintain equipment - NOVA analyzers, pH meters, CO2 analyzers, pH and DO simulators, microscope, pipettors, Vi-Cell cell counter, and CIP skid
  • Harvest operations - pod filtration and TFF system
  • Help create and actively support 5S, Area Improvement, and Safety Team initiatives to ensure a Continuous Improvement culture throughout the department
  • Revise and initiate Batch Production Records (BPRs), Standard Operating Procedures (SOPs), and forms using cGMP Documentation
  • Collaborate with other departments for raw materials, water, testing requirements, documentation, validation, maintenance, and scheduling
  • Identify, escalate, and report deviations (IRs/DRs/CAPAs)
  • Troubleshoot equipment and process issues in collaboration with Facilities (FAC), Manufacturing Technical Operations (MTO), Manufacturing Quality Sciences (MQS) and Validation (VAL) departments.
  • Ensure that equipment and material are available as required for each production run.
  • Identify the technical, procedural, and equipment issues that hinder production and compliance. Inform support departments and manager as needed.
  • Assist in the transfer of technology from PD to cGMP Manufacturing.
  • Assist with periodic technical and compliance investigations, inspections, and audits.
  • Operate and maintain Getinge Autoclave and Gruenberg Oven.
  • Related Bachelor's degree (Biology, Biotechnology, Chemical Engineering)
  • Biotech industry experience is required to include a minimum of one to three years cGMP mammalian and/or fermentation cell culture experience at the Associate level and two to five years' experience at the Senior Associate level.
  • Professional experience working for a contract manufacturing organization in the life sciences field is preferred.
  • Proficient in personal computer skills, including e-mail, record keeping, routine database activity, word processing, spreadsheets, and graphics.
  • Ability to handle and prioritize multiple tasks and projects simultaneously.
  • Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
  • Ability to write routine reports and correspondence.
  • Ability to speak effectively before groups of customers or employees of organization.
  • Must be able to gown for a class 10,000 cleanroom environment and work under aseptic conditions in a class 100 environment (BSC and LAF).
Please send resumes to and visit our website at for additional job opportunities!!!

BioPhase Solutions


Orange County, CA



View all jobs at BioPhase Solutions

What email should the hiring manager reach you at?

By clicking the button above, I agree to the ZipRecruiter Terms of Use and acknowledge I have read the Privacy Policy, and agree to receive email job alerts.