Overview
On Site
Depends on Experience
Contract - W2
Contract - 6 Month(s)
Skills
Chromatography
Downstream
Upstream
GMP
Filtration
Purification
Job Details
BRIEF DESCRIPTION OF DUTIES:
Job Title: Senior Process Development Associate-C
Location: San Diego, California, 92111 (Onsite)
Duration: 6 Month contract (40hrs./week)
Job Description: Downstream Pilot Plant Associate
Position Summary (Overview of Role):
Join a growing team as a key member in the Manufacturing department where you can see the result of your contributions benefit patients lives. As a Downstream Pilot Plant Associate, you play an integral role in ensuring the on-time delivery of quality Gene Therapy products. You will participate in diverse activities including downstream process execution, maintaining GLP documentation, operating and maintaining process equipment, authoring records and procedures, and supporting continuous improvement efforts for manufacturing viral vector gene therapy.
Responsibilities (Essential Role Responsibilities):
Perform downstream purification processes, including chromatography, ultrafiltration, tangential flow filtration and depth filtration, at pilot and production scales.
Operate and maintain standard bioprocessing equipment such as chromatography systems, ultracentrifuges, and tangential flow filtration (TFF) units.
Adhere strictly to current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) in all activities.
Prepare, review, and maintain batch records, SOPs, logbooks, raw material specifications, campaign summary reports, technology transfer documents, and presentations in compliance with regulatory requirements.
Collaborate with cross-functional teams to support manufacturing investigations, root cause analysis, and process troubleshooting.
Ensure compliance with company SOPs, training requirements, and scale-up best practices.
Maintain facility readiness and support regulatory inspections through vigilant oversight.
Utilize Quality Systems and ERP platforms to document and track manufacturing activities.
Drive process improvements through the change control process or other initiatives.
Apply professional expertise to routine assignments; may supervise or serve as lead during on-floor activities.
Provide process subject matter expertise and take ownership of assigned deliverables.
Preferred: Experience conducting manufacturing investigations in biologics production.
Demonstrate strong technical writing and communication skills.
Maintain a safe working environment and stay current with all assigned training.
The hourly range for roles of this nature are $45 to $80/hr. Rates are heavily dependent on skills, experience, location and industry.
CyberThink is an Equal Opportunity Employer.
Best Regards,
Anas Bin Iqbal
cyberThink Inc.
Bridgewater, NJ 08807-1774
Work:
Click here to Apply
Job Title: Senior Process Development Associate-C
Location: San Diego, California, 92111 (Onsite)
Duration: 6 Month contract (40hrs./week)
Job Description: Downstream Pilot Plant Associate
Position Summary (Overview of Role):
Join a growing team as a key member in the Manufacturing department where you can see the result of your contributions benefit patients lives. As a Downstream Pilot Plant Associate, you play an integral role in ensuring the on-time delivery of quality Gene Therapy products. You will participate in diverse activities including downstream process execution, maintaining GLP documentation, operating and maintaining process equipment, authoring records and procedures, and supporting continuous improvement efforts for manufacturing viral vector gene therapy.
Responsibilities (Essential Role Responsibilities):
Perform downstream purification processes, including chromatography, ultrafiltration, tangential flow filtration and depth filtration, at pilot and production scales.
Operate and maintain standard bioprocessing equipment such as chromatography systems, ultracentrifuges, and tangential flow filtration (TFF) units.
Adhere strictly to current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) in all activities.
Prepare, review, and maintain batch records, SOPs, logbooks, raw material specifications, campaign summary reports, technology transfer documents, and presentations in compliance with regulatory requirements.
Collaborate with cross-functional teams to support manufacturing investigations, root cause analysis, and process troubleshooting.
Ensure compliance with company SOPs, training requirements, and scale-up best practices.
Maintain facility readiness and support regulatory inspections through vigilant oversight.
Utilize Quality Systems and ERP platforms to document and track manufacturing activities.
Drive process improvements through the change control process or other initiatives.
Apply professional expertise to routine assignments; may supervise or serve as lead during on-floor activities.
Provide process subject matter expertise and take ownership of assigned deliverables.
Preferred: Experience conducting manufacturing investigations in biologics production.
Demonstrate strong technical writing and communication skills.
Maintain a safe working environment and stay current with all assigned training.
The hourly range for roles of this nature are $45 to $80/hr. Rates are heavily dependent on skills, experience, location and industry.
CyberThink is an Equal Opportunity Employer.
Best Regards,
Anas Bin Iqbal
cyberThink Inc.
Bridgewater, NJ 08807-1774
Work:
Click here to Apply
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