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 Process Development Downstream Manager is a critical contributor to our organization. This role involves scouting for technology, providing insights for strategic technology selection, and leading its implementation within GenScript ProBio's CGT business unit. This position oversees the development and optimization of downstream processes for plasmid DNA production, with the goal of reducing development cycle times and improving cost-effectiveness (COGs). This position requires a deep technical background in downstream processes and extensive hands-on experience. The successful candidate will lead a team of senior scientists, scientists, and associates, driving process development, optimization, PreCMC and CMC production, new technology development, and technology transfer to deliver high-quality work to clients.
Position Information
- Work Location: Piscataway, NJ/East Hanover, NJ
- Reports to: Head of PD/MSAT
- Direct Reports: Senior Scientist/Scientist/Associate
Roles And Responsibilities：
- Lead a matrix group to develop, improve, troubleshoot, and implement scalable high-yielding processes using novel and/or existing technologies for plasmid DNA, and related new modalities to support early and late-stage cell and gene therapy programs.
- Supervise, mentor, and train a team of senior scientists and scientists for downstream process development in lysis, depth-filtration, TFF, and chromatography, and scale-up to MFG large-scale single-use systems to purify plasmid DNA from upstream cell broth.
- Oversee and execute experiment design, execution, analysis, and reporting for clients and internal programs using ultrafiltration, AKTA, etc. systems, focusing on improving yield, purity, and efficiency.
- Assess and adopt new methods, techniques, and technology platforms, including equipment demonstrations, to continually enhance the downstream process. Stay abreast of the latest developments in downstream processes for plasmid DNA purification.
- Play a key role in technical transfer, including scale-up activities, proposal and statement of work (SOW) reviews, and person-in-plant support as needed.
- Author and review detailed process descriptions and technical reports to document study outcomes and justify process changes and/or process updates. Prepare technical reports, documentation for regulatory submissions, and standard operating procedures (SOPs) based on your extensive knowledge and best practices.
- Collaborate and maintain open communication with colleagues in upstream, analytical, quality control (QC), quality assurance (QA), and manufacturing departments, ensuring they are well-informed about downstream projects.
- Foster a collaborative and results-oriented team environment, leveraging your wealth of experience to guide and support team members. Establish performance expectations based on your deep expertise, conduct regular performance reviews, and provide constructive feedback.
- Develop and implement advanced quality control procedures, drawing from your expertise, to monitor product quality throughout the downstream process.
- Maintain comprehensive records of all downstream processing activities, ensuring data accuracy and traceability.
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.