ProBio
Scientist, Downstream Process Development
GenScript Biotech Corporation 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 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. ProBio proactively provides end-to-end CDMO service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in cell and gene therapy, vaccine, biologics discovery and antibody protein drug to accelerate drug development for customers. Position Overview : The position reports to the Associate Director, Downstream Viral Vector Process Development & MSAT Department. This role is ideally suited for a dynamic bench-focused individual to support/lead translation of research process to GMP-compliant manufacturing, and will develop, scale-up, and evaluate the technology transfer of viral vector processes. Hands-on experimental work in the development and optimization of downstream unit operations for viral vector manufacturing process. Contribute to the planning, design, and execution of AAV/LVV purification-related experiments to analyze, interpret, and report data summary packages. Interact and collaborate with internal/external partnerships to evaluate and implement new bioprocessing technologies and strategies. Interact with cross functional teams to support process technology transfer, cGMP risk evaluation, and deviation management. Maintain and follow detailed and comprehensive project timelines. Support in the preparation of CMC sections for regulatory submissions. Present updates to project or upper management teams on process development and manufacturing support activities. Read and understand scientific literature in gene and cell therapy. Perform other duties as assigned based on business needs. Qualifications : Bachelor’s degree with 3-7 years, or Master’s or Ph.D. degree with 1-3 years’ relevant industry experience in Chemical/Biochemical Engineering, Biological Sciences, or a related scientific discipline in biotech development. Previous experience in viral vector process development and manufacturing is highly preferred. Strong understanding of process scale-up and scale-down modeling. Good understanding of Design of Experiment (DOE) and statistical analysis. Experience in CMC regulatory affairs for FDA, and EMA is a plus. Strong organizational skills and detailed documentation abilities are required. Work independently in hands-on laboratory setting, self-motivated to learn and develop new techniques. Strong interpersonal, verbal, and written communication skills. Results oriented, be able to effectively prioritize and complete tasks on time. Collaboration and teamwork. Compensation : The salary range, dependent upon experience level, is $80,000 - $110,000 annually. GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce.
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GenScript Biotech Corporation 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 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. ProBio proactively provides end-to-end CDMO service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in cell and gene therapy, vaccine, biologics discovery and antibody protein drug to accelerate drug development for customers. Position Overview : The position reports to the Associate Director, Downstream Viral Vector Process Development & MSAT Department. This role is ideally suited for a dynamic bench-focused individual to support/lead translation of research process to GMP-compliant manufacturing, and will develop, scale-up, and evaluate the technology transfer of viral vector processes. Hands-on experimental work in the development and optimization of downstream unit operations for viral vector manufacturing process. Contribute to the planning, design, and execution of AAV/LVV purification-related experiments to analyze, interpret, and report data summary packages. Interact and collaborate with internal/external partnerships to evaluate and implement new bioprocessing technologies and strategies. Interact with cross functional teams to support process technology transfer, cGMP risk evaluation, and deviation management. Maintain and follow detailed and comprehensive project timelines. Support in the preparation of CMC sections for regulatory submissions. Present updates to project or upper management teams on process development and manufacturing support activities. Read and understand scientific literature in gene and cell therapy. Perform other duties as assigned based on business needs. Qualifications : Bachelor’s degree with 3-7 years, or Master’s or Ph.D. degree with 1-3 years’ relevant industry experience in Chemical/Biochemical Engineering, Biological Sciences, or a related scientific discipline in biotech development. Previous experience in viral vector process development and manufacturing is highly preferred. Strong understanding of process scale-up and scale-down modeling. Good understanding of Design of Experiment (DOE) and statistical analysis. Experience in CMC regulatory affairs for FDA, and EMA is a plus. Strong organizational skills and detailed documentation abilities are required. Work independently in hands-on laboratory setting, self-motivated to learn and develop new techniques. Strong interpersonal, verbal, and written communication skills. Results oriented, be able to effectively prioritize and complete tasks on time. Collaboration and teamwork. Compensation : The salary range, dependent upon experience level, is $80,000 - $110,000 annually. GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce.
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