GenScript/ProBio
biotechnology
(Sr)Technician,UpstreamProcess
Neural analysis suggests this role is
optimal for Mid+ candidates.
“(Sr) Technician, Upstream Process at GenScript/ProBio. Skills: process management, cross-functional coordination, vendor/stakeholder management, operational metrics, resource planning, continuous improvement. recognizes deviations from procedures and raises issue to management for resolution. Adheres to current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs)”
What You'll Achieve.
Tracks and ensures closure of observations
Industry & Context.
recognizes deviations from procedures and raises issue to management for resolution; Participates in low risk deviations investigations; Assists in the implementation of Corrective Action / Preventative Actions (CAPA) action items within agreed upon timelines
What They're Looking For.
Must Have
Demonstrated ability to follow written instructions and procedures, Demonstrated ability to pay strict attention to detail, Proficiency with Microsoft Office, Excellent verbal and written communication and skills, Ability to work collaboratively as part of a team, in a fast-paced, matrixed, team environment consisting of internal and external team members
What You'll Do.
recognizes deviations from procedures and raises issue to management for resolution
Adheres to current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs)
Performs routine microbial and mammalian cell culture using aseptic techniques
Monitors microbial fermenters and mammalian cell cultures bioreactors
Weighs and checks raw materials
assembles process equipment
and monitors processes
Completes work instructions and maintains clean room environment to comply with regulatory requirements
Removes red bag waste as required
Operates all production equipment in assigned functional area such as disposable fermenters
other disposable Bioprocess equipment
and media preparation equipment as per written procedures
Authors solution preparation Master Batch Records (MBRs) by transferring technical information from scientific and development documents
Proposes and routes revisions to existing SOP’s for functional area equipment
Works to become proficient on common bioprocessing equipment
Participates in low risk deviations investigations
Assists in the implementation of Corrective Action / Preventative Actions (CAPA) action items within agreed upon timelines
Conducts Safety and GMP self-auditing walkthroughs
documenting observations for assignment and closure dates
Tracks and ensures closure of observations
Logs and submits samples in Laboratory Information Management System (LIMS); tracks results and compiles data
Reviews own work for completeness on executed Master Batch Records (MBRs)
Coordinate the tracking and return of executed records to Quality department for review
Coordinates with Logistics to ensure needed materials are delivered to the production area timely
Monitors future needs against material supply to alert Logistics of shortfalls
Performs other tasks and assignments as needed and specified by management
How You'll Work.
Team & Collaboration
Ability to work collaboratively as part of a team, in a fast-paced, matrixed, team environment consisting of internal and external team members; Coordinates with Logistics to ensure needed materials are delivered to the production area timely
Communication Scope
Excellent verbal and written communication and skills
Process & Methodology
Assists in the implementation of Corrective Action / Preventative Actions (CAPA) action items within agreed upon timelines
Full Job Description
About GenScript GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy. GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology. About ProBio: ProBio, a subsidiary of GenScript, is a global CDMO offering end-to-end services from discovery to GMP for plasmids, antibodies, and cell recognizes deviations from procedures and raises issue to management for resolution. Adheres to current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs). Performs routine microbial and mammalian cell culture using aseptic techniques. Monitors microbial fermenters and mammalian cell cultures bioreactors. Weighs and checks raw materials, assembles process equipment, and monitors processes. Completes work instructions and maintains clean room environment to comply with regulatory requirements. Removes red bag waste as required. Operates all production equipment in assigned functional area such as disposable fermenters, bioreactors, other disposable Bioprocess equipment, and media preparation equipment as per written procedures. Authors solution preparation Master Batch Records (MBRs) by transferring technical information from scientific and development documents. Proposes and routes revisions to existing SOP’s for functional area equipment. Works to become proficient on common bioprocessing equipment. Participates in low risk deviations investigations. Assists in the implementation of Corrective Action / Preventative Actions (CAPA) action items within agreed upo
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