Sr Technician, Downstream Process

GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group founded in 2002 with a presence across North America, Europe, the Greater China, and Asia Pacific. Its businesses include a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy, driven by leading gene synthesis technology. GenScript is committed to becoming the world’s most reliable biotech company, advancing human and environmental health through biotechnology.

Pro Bio, a subsidiary of GenScript, is a global CDMO offering end‑to‑end services from discovery to GMP for plasmids, antibodies, and cell & gene therapies. It brings together multidisciplinary expertise to accelerate development and manufacturing through customized and comprehensive services. Pro Bio operates in the United States, the Netherlands, South Korea, and China (Hong Kong, Shanghai, Nanjing) and has helped customers across the globe obtain more than 150 IND approvals since October 2017.

The (Sr) Technician, Downstream Process will work within the Downstream Processing group and perform the following activities while executing Downstream operations:

• Preparation of stock solutions and buffers.
• Filtration of stock solutions and buffers.
• Operate all production equipment in the assigned functional area such as single‑use chromatography systems, chromatography columns, other disposable bioprocess equipment, and solution preparation equipment per written procedures.
• Support relevant regulatory requirements and company SOPs as appropriate.

• Execute routine complex manufacturing assignments per written procedures; recognize deviations and raise issues for resolution.
• Adhere to current Good Manufacturing Practices (cGMP) and SOPs.
• Perform routine microbial and mammalian purification; monitor chromatography and tangential flow filtration (TFF) systems during processing.
• Weigh and check raw materials, assemble process equipment, and monitor processes.
• Complete work instructions and maintain a clean‑room environment to comply with regulatory requirements.
• Operate all production equipment in the assigned functional area per written procedures.
• Author solution preparation Master Batch Records (MBRs) by transferring technical information from scientific and development documents.
• Propose and route revisions to existing SOPs for functional‑area equipment.
• Work to become proficient on common bioprocessing equipment.
• Conduct safety and GMP self‑auditing walkthroughs, documenting observations and tracking closure.
• Log and submit samples in the Laboratory Information Management System (LIMS); track results and compile data.
• Review own work for completeness on executed MBRs.
• Coordinate the tracking and return of executed records to the Quality department for review.
• Coordinate with Logistics to ensure timely delivery of needed materials; monitor future needs and alert Logistics of shortfalls.
• Perform other tasks and assignments as needed and specified by management.

• Bachelor’s degree in science or engineering with 0–5 years of relevant experience; or Associate’s degree with a minimum of 3 years of relevant experience; or high school diploma with a minimum of 7 years of relevant experience.
• 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 skills.
• Ability to work collaboratively as part of a team in a fast‑paced, matrixed environment.

Location:

Pennington, NJ

The estimated pay range for the role is between $60,000 – $75,000 based on qualifications and experience.

GenScript USA Inc./Pro Bio Inc. is a proud equal‑opportunity/affirmative action employer committed to attracting and retaining a diverse and inclusive workforce. The Company maintains a drug‑free workplace.

Please note:

GenScript USA Inc./Pro Bio Inc. will only contact candidates through verified application sources. GenScript/Pro Bio does not request personal information from candidates through individual email or any other platform.