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Form of workJob 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 GenScript ProBio
GenScript ProBio is the subsidiary of GenScript Biotech Corporation, proactively providing end-to-end CDMO service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in cell and gene therapy (CGT), vaccine, biologics discovery and antibody protein drug to accelerate drug development for customers. GenScript ProBio's total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing. In terms of plasmid service, GenScript ProBio supports the most clinical approvals for CGT drugs including mRNA vaccines, CAR-T in China. It is also the first GMP manufacturing platform to provide in vitro transcription (IVT) template linearized plasmids for mRNA vaccines and has supported several mRNA vaccine global enterprises to obtain clinical approvals. In terms of viral vector service, GenScript ProBio has a stable and high-yield viral vector platform.
Job Scope:
The position reports to the Validation Director/Manager and is ideally suited for a professional with background in facility/utility/equipment/CSV validation. This is a great opportunity to lead and evolve this function within a CDMO business, to support a broad portfolio and advance the manufacturing capabilities to deliver products to the client projects that transform the lives of patients.
Position Information:
- Work Location: Piscataway, NJ / East Hanover, NJ
- Reports to: Sr. QA Manager
Responsibilities
- Responsible for non-GMP QA support of production of CGT products, including plasmid, mRNA, and viral vectors.
- In-process monitoring of key steps in production process
- Responsible for training management and document archives
- Responsible for data integrity inspections
- Review and approval of quality events
- Participate in production support tasks as required
- Participate in other quality operation and quality systems tasks as required
Qualification
- BS in life science or related field
- Up to 3 years experience in drug/biologics production support
- Familiar with Non-Clinical, Pre-Clinical and GLP operational principles and practices
- Familiarity with bio-processing, including cell banking, fermentation, purification, fill and finish
- Works independently, self-motivated, and results oriented
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GenScript USA Inc/GenScript ProBio USA Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.
GenScript USA Inc./GenScript ProBio USA Inc. maintains a drug-free workplace.
