About the Role

The (Sr) Technician, Upstream Process will support upstream processing activities such as preparing solutions, operating disposable bioreactors, expanding microbial and mammalian cell lines, and adhering to regulatory and procedural standards within the production environment.

Responsibilities

Carries out complex, routine manufacturing tasks following documented procedures and flags any deviations to management for resolution.
Follows current Good Manufacturing Practices and Standard Operating Procedures in all activities.
Conducts routine microbial and mammalian cell culture using sterile techniques and monitors fermenters and bioreactors.
Measures and verifies raw materials, sets up process equipment, and oversees production processes.
Completes work instructions and maintains clean room conditions to meet regulatory standards, including proper disposal of red bag waste.
Operates assigned production equipment such as disposable fermenters, bioreactors, bioprocess systems, and media preparation units according to written protocols.
Creates Master Batch Records for solution preparation by translating technical data from development and scientific documentation.
Suggests and submits updates to SOPs for equipment in the assigned area.
Develops proficiency with common bioprocessing systems and technologies.
Participates in investigations of low-risk deviations and supports timely implementation of corrective and preventative actions.
Performs self-audits for safety and GMP compliance, records findings, and ensures timely resolution.
Logs and submits samples in the Laboratory Information Management System, tracks results, and compiles relevant data.
Reviews completed Master Batch Records for accuracy and completeness.
Coordinates the return of executed records to the Quality department for review and tracking.
Collaborates with Logistics to ensure timely delivery of materials and communicates potential supply shortfalls based on future needs.
Performs additional duties as assigned by management.

Work Arrangement

On-site — Pennington, New Jersey

About GenScript

GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group founded in 2002, with operations across North America, Europe, Greater China, and Asia Pacific. The company leverages its gene synthesis technology across four key areas: life science CRO services, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy. Its mission is to become the most trusted biotech company globally by improving human and environmental health through biotechnology.

About ProBio

ProBio, a GenScript subsidiary, is a global CDMO providing end-to-end services from discovery to GMP manufacturing for plasmids, antibodies, and cell and gene therapies. With multidisciplinary expertise, it offers customized solutions to accelerate development and manufacturing. ProBio operates in the United States, the Netherlands, South Korea, China (Hong Kong, Shanghai, Nanjing), and other regions, supporting clients worldwide. Since October 2017, it has contributed to over 150 IND approvals in the U.S., Europe, and Asia Pacific.

About the job

The (Sr) Technician, Upstream Process will work in the Upstream Processing group, performing tasks such as preparing stock solutions, buffers, and media; filtering solutions; setting up and operating disposable fermenters, bioreactors, and related bioprocess equipment; and maintaining microbial and mammalian cell lines. The role also involves compliance with regulatory standards and company SOPs.