Manufacturing Associate/Sr. Associate (Downstream) Job at BioPhase Solutions, Orange County, CA

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  • BioPhase Solutions
  • Orange County, CA

Job Description

Job Description

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 (Downstream) to work for a leading Orange County area contract manufacturing company.

Pay Rate: $50-70k depending on experience.

This role is a full-time, non-exempt position.

Flexible schedule due to operations/scheduling.

  • Work overtime and weekends as necessary
  • Shift work: Sun-Wed or Wed-Sat, 4 days x 10 hours

Summary:

The Manufacturing Associate/Sr. Associate performs Product Manufacturing tasks or provides Manufacturing Support in strict compliance with cGMP, under Standard Operating Procedures in a multi-product manufacturing facility, including, but not limited to: production, documentation, writing reports, requesting and purchasing materials, and scheduling equipment services and calibrations. The Manufacturing Associate will play an integral role in ensuring the production and on-time release of quality products.

Responsibilities:

  • Ensure equipment and materials are in place as required for each production run
  • Plan and prepare needs for processes and activities
  • Operate and maintain BioProcess chromatography skid
  • Pack, unpack, and clean production scale chromatography columns
  • Antibody and enzyme purification via Affinity chromatography, Size Exclusion chromatography, Ion Exchange chromatography, Hydrophobic Interaction and Tangential Flow Filtration (TFF)
  • pH and conductivity meter calibration and testing
  • Product filtration (sterile filtration, ultrafiltration, viral filtration)
  • Aseptic technique utilizing excellent hand skills with slow, deliberate movement
  • Product filling (aseptic processing including media fill qualifications)
  • Maintain and clean cleanroom facility and equipment
  • Control and track raw material inventory
  • GMP documentation
  • Revise and initiate Batch Production Records, Standard Operation Procedures, study protocols and reports
  • Lead independent projects as assigned

Other Duties:

  • Prepare media and buffer solutions
  • Manually clean small parts and equipment
  • Filter integrity testing utilizing Sartocheck 3/4 Filter Integrity Tester
  • Operate and maintain ARS Frontier Autoclave
  • Operate and maintain Gruenberg Oven
  • Perform daily monitoring of equipment
  • Prepare glassware and equipment for production

Qualifications:

  • Bachelors degree in a life sciences discipline required
  • A minimum of one to two years (three to four years for Sr. level) related life sciences industry experience
  • Need two years of experience working with large scale liquid chromatography columns or similar equipment
  • Require experience working in a GMP production environment with aseptic technique
  • Must be able to gown for a class 10,000 cleanroom environment and work under aseptic conditions in a class 100 environment

Please send resumes to vanessa@biophaseinc.com and visit our website at for additional job opportunities!!!

Job Tags

Full time, Contract work, Flexible hours, Shift work, Weekend work,

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