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!!!

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