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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
Responsibilities:
  • 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.
Qualifications:
  • 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 tiffany@biophaseinc.com and visit our website at www.biophaseinc.com for additional job opportunities!!!

BioPhase Solutions

Address

Orange County, CA
USA

Industry

Manufacturing

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