GenScript USA Inc.
(Sr). Scientist, Downstream Process Development Pennington, NJ
GenScript USA Inc., Trenton, New Jersey, United States
Sr. Scientist, Downstream Process Development
Pennington, NJ Overview
GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. GenScript’s businesses include life science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy. ProBio provides end-to-end CDMO services from drug discovery to commercialization for cell and gene therapy, vaccine, biologics discovery and antibody protein drug development. Responsibilities
Hands-on experimental work in the development and optimization of downstream unit operations (TFF, affinity/ion exchange/multimodal chromatography, viral clearance, sterile filtration, etc.) for viral vector manufacturing processes. Contribute to planning, design, and execution of AAV/LVV purification-related experiments; analyze, interpret, and report data in summary packages. Collaborate with internal/external partnerships to evaluate and implement new bioprocessing technologies and strategies. Work with cross-functional teams (Analytic, Manufacturing, Supply Chain, Facility, QA, QC) to support process technology transfer, cGMP risk evaluation, and deviation management. Maintain and follow detailed project timelines. Assist in preparing CMC sections for regulatory submissions (IND, Annual Reports, BLA), invention disclosures, progress reports, and publications. Present updates to project or upper management on process development and manufacturing support activities. Read and interpret scientific literature in gene and cell therapy to generate ideas and contribute to process design and development. Perform other duties as assigned based on business needs. Qualifications
Bachelor’s degree with 3-7 years, or Master’s/Ph.D. with 1-3 years in Chemical/Biochemical Engineering, Biological Sciences, or related biotech field; experience in gene and cell therapy product design is desired. LVV and AAV process development experience is a plus. Previous experience in viral vector process development and manufacturing is highly preferred. Strong understanding of process scale-up and scale-down modeling. Knowledge of Design of Experiment (DOE) and statistical analysis. Experience with CMC regulatory affairs for FDA/EMA is a plus. Strong organizational skills and detailed documentation abilities. Ability to work independently in a hands-on laboratory setting; self-motivated to learn and develop new techniques. Strong interpersonal, verbal, and written communication skills. Results-oriented with the ability to prioritize and complete tasks on time. Collaborative and team-oriented; able to thrive in a fast-paced, multi-tasking biotech environment. Compensation
The salary range, dependent upon experience level, is $80,000 - $110,000 annually. Equal Opportunity
GenScript USA Inc./ProBio Inc. is an 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 provide 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 partnership status, genetic information, citizenship status, veteran status, or any other characteristic protected by law. GenScript USA Inc./ProBio Inc. maintains a drug-free workplace. Application and Privacy
GenScript/ProBio communicates with candidates through verified application sources. The company does not request personal information from candidates through individual email or other platforms.
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Pennington, NJ Overview
GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. GenScript’s businesses include life science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy. ProBio provides end-to-end CDMO services from drug discovery to commercialization for cell and gene therapy, vaccine, biologics discovery and antibody protein drug development. Responsibilities
Hands-on experimental work in the development and optimization of downstream unit operations (TFF, affinity/ion exchange/multimodal chromatography, viral clearance, sterile filtration, etc.) for viral vector manufacturing processes. Contribute to planning, design, and execution of AAV/LVV purification-related experiments; analyze, interpret, and report data in summary packages. Collaborate with internal/external partnerships to evaluate and implement new bioprocessing technologies and strategies. Work with cross-functional teams (Analytic, Manufacturing, Supply Chain, Facility, QA, QC) to support process technology transfer, cGMP risk evaluation, and deviation management. Maintain and follow detailed project timelines. Assist in preparing CMC sections for regulatory submissions (IND, Annual Reports, BLA), invention disclosures, progress reports, and publications. Present updates to project or upper management on process development and manufacturing support activities. Read and interpret scientific literature in gene and cell therapy to generate ideas and contribute to process design and development. Perform other duties as assigned based on business needs. Qualifications
Bachelor’s degree with 3-7 years, or Master’s/Ph.D. with 1-3 years in Chemical/Biochemical Engineering, Biological Sciences, or related biotech field; experience in gene and cell therapy product design is desired. LVV and AAV process development experience is a plus. Previous experience in viral vector process development and manufacturing is highly preferred. Strong understanding of process scale-up and scale-down modeling. Knowledge of Design of Experiment (DOE) and statistical analysis. Experience with CMC regulatory affairs for FDA/EMA is a plus. Strong organizational skills and detailed documentation abilities. Ability to work independently in a hands-on laboratory setting; self-motivated to learn and develop new techniques. Strong interpersonal, verbal, and written communication skills. Results-oriented with the ability to prioritize and complete tasks on time. Collaborative and team-oriented; able to thrive in a fast-paced, multi-tasking biotech environment. Compensation
The salary range, dependent upon experience level, is $80,000 - $110,000 annually. Equal Opportunity
GenScript USA Inc./ProBio Inc. is an 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 provide 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 partnership status, genetic information, citizenship status, veteran status, or any other characteristic protected by law. GenScript USA Inc./ProBio Inc. maintains a drug-free workplace. Application and Privacy
GenScript/ProBio communicates with candidates through verified application sources. The company does not request personal information from candidates through individual email or other platforms.
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