Upstream Processing Bioprocess Technician
2 weeks ago
Company Background
GenScript Biotech Corporation is a prominent global player in the biotechnology sector, established in 2002. With a strong foothold in North America, Europe, Greater China, and Asia Pacific, GenScript specializes in various domains, leveraging its cutting-edge gene synthesis technology. The company operates across four primary sectors: Life Science Contract Research Organization (CRO), enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.
GenScript is dedicated to its mission of enhancing health for both humanity and nature through innovative biotechnological solutions.
About GenScript ProBio
As a subsidiary of GenScript Biotech Corporation, GenScript ProBio offers comprehensive Contract Development and Manufacturing Organization (CDMO) services. These services span from drug discovery to commercialization, focusing on cell and gene therapy (CGT), vaccine development, biologics discovery, and antibody protein drugs. GenScript ProBio's holistic approach to cell and gene therapy includes CMC for plasmid and viral vectors for IND filing, alongside clinical and commercial manufacturing capabilities. Notably, it has supported numerous clinical approvals for CGT drugs, including mRNA vaccines and CAR-T therapies.
Position Summary:
The Bioprocess Technician/Specialist for Upstream Processing will engage with the Upstream Processing team, executing essential upstream operations, which include:
- Preparation of stock solutions, buffers, and media.
- Filtration processes for stock solutions, buffers, and media.
- Setup and operation of disposable fermenters and bioreactors, along with other bioprocess equipment.
- Passaging and expanding microbial and mammalian cell lines.
This role also involves adherence to regulatory standards and company Standard Operating Procedures (SOPs).
Key Responsibilities:
- Conducts complex manufacturing tasks according to established procedures, identifying and reporting deviations to management.
- Maintains compliance with current Good Manufacturing Practices (cGMP) and relevant SOPs.
- Performs routine microbial and mammalian cell culture utilizing aseptic techniques, while monitoring bioreactors.
- Weighs and verifies raw materials, assembles process equipment, and oversees production processes.
- Completes work instructions and upholds a cleanroom environment to meet regulatory standards.
- Operates all production equipment within the designated area, including disposable fermenters and media preparation tools.
- Creates Master Batch Records (MBRs) by accurately transferring technical information from scientific documents.
- Suggests revisions to existing SOPs for equipment in the functional area.
- Aims to achieve proficiency in common bioprocessing equipment.
- Participates in investigations of low-risk deviations and assists in implementing corrective actions within set timelines.
- Conducts self-audits for safety and GMP compliance, documenting findings for resolution.
- Logs and submits samples in the Laboratory Information Management System (LIMS), tracking results and compiling data.
- Reviews completed Master Batch Records for accuracy.
- Coordinates with the Quality department for the review of executed records.
- Collaborates with Logistics to ensure timely delivery of necessary materials to the production area.
- Performs additional tasks as assigned by management.
Qualifications:
- Bachelor's degree in a scientific or engineering discipline with 0-5 years of relevant experience, or an associate's degree with a minimum of 3 years of experience, or a high school diploma with at least 7 years of relevant experience.
- Proven ability to follow detailed written instructions and procedures.
- Strong attention to detail.
- Proficiency in Microsoft Office applications.
- Excellent verbal and written communication skills.
- Ability to work effectively as part of a team in a dynamic, matrixed environment.
GenScript USA Inc./GenScript ProBio USA Inc. is an equal opportunity employer committed to fostering a diverse and inclusive workforce.
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