ProBio-Scientist, Downstream Process Development (PD) and MSAT

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 individual functions with supervision as Scientist I II or III and is actively engaged in downstream plasmid DNA purification process development and MSAT within a dynamic project team. Displays strong technical knowledge, initiative, and scientific commitment and makes significant scientific and technical contributions within PD & MSAT group.

Position Information:

Worl Location: Piscataway, NJ/Hopewell, NJ

Reports to: Manager of PD Downstream and MSAT

Roles and Responsibilities:
Process Development: Collaborate with the team to design, develop, and optimize downstream processes for purifying plasmid DNA or proteins.
Experimental Work: Execute experiments and studies for PreCMC and CMC productions, evaluation of purification processes, including but not limited to bacterial lysis, chromatography, filtration, and ultrafiltration/diafiltration (UFDF) techniques. Focus on yield, purity, and process efficiency improvements.
Data Analysis: Analyze and interpret experimental data, troubleshoot any issues that arise during process development, translate data into findings, draw sound conclusions, and propose improvement solutions.
Technology Assessment: Stay updated on the latest downstream processing technologies and techniques advancements. Evaluate and recommend new methods or equipment for process enhancement.
Documentation: Prepare detailed process documentation, including standard operating procedures (SOPs), batch records, and technical reports. Maintain accurate and organized records of experiments and results.
Scale-Up and Tech Transfer: Assist in the scale-up of processes for larger-scale production. Participate in technology transfer activities to enable successful process implementation in manufacturing.
Collaboration: Collaborate effectively with cross-functional teams, including upstream process development, analytical development, quality control, and manufacturing teams.
Regulatory Compliance: Ensure all activities adhere to regulatory guidelines and quality standards. Contribute to regulatory submissions and audits as needed.
Safety and Compliance: Adhere to safety protocols and promote a safety culture in the laboratory.

Qualifications:
Bachelor's with minimum 4 years of industry experience or Master's degree with 6 years of experience in a relevant scientific discipline (e.g., Biochemistry, Biotechnology, Chemical Engineering).
Demonstrated experience in downstream process development, ideally in plasmid DNA purification, viral vector, or protein purification.
Hands-on experience with chromatography, filtration, and UF/DF techniques is highly desirable.
Knowledge and experience in buffer and reagent preparation, including pH and conductivity measurement, molarity calculation, and density measurement.
Proficiency in data analysis and laboratory techniques, including statistical analysis software and relevant bioprocess software.
Strong communication skills, both written and verbal, and the ability to collaborate effectively within a team.
Effectively communicates results of own work through client meetings, presentations, discussions, and documentation with input from supervisor.
Familiarity with regulatory requirements and quality compliance in the biopharmaceutical industry is a plus.
Self-motivated, detail-oriented, and able to work independently with minimum supervision.
Flexibility to adapt to changing project priorities and timelines.
Individual is required to sit, stand, and walk regularly
The ability to lift 10 - 50 pounds regularly
Be accessible to lab and office areas to interact with staff and use required office and lab equipment
Specific vision requirements include reading of written documents and frequent use of computer monitors

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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.
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