GenScript
GenScript Biotech Corporation / ProBio
GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group with a presence across North America, Europe, the Greater China, and Asia Pacific. ProBio provides end-to-end CDMO services from drug discovery to commercialization in cell and gene therapy, vaccine, biologics discovery and antibody protein drug, including CMC support for plasmid and virus IND filing and clinical/commercial manufacturing. Job Scope
The position reports to the Sr. QC Manager and is suited for a professional with extensive technical knowledge and a proven track record of developing and executing processes for GMP manufacturing of a wide range of clinical trial materials, and for participating in technology transfer. This role offers the opportunity to lead and evolve QC-Operations within a CDMO setting, supporting a broad portfolio and advancing manufacturing capabilities to deliver client projects that impact patients’ lives. Responsibilities
Support in the setup, development and optimization of GMP QC-Operations Laboratories, primarily launching and supporting Non-GMP and GMP AAV production. Support QC-Operations initiatives including equipment qualification, method development, method validation, and tech-transfer. Support method lifecycle initiatives. Author and/or review protocols, executions and reporting for developed methods. Perform a wide range of analytical tests, including CE-SDS, AUC, ELISA, ddPCR, HPLC, and DNA Sequencing/Analysis. Develop and lead optimization initiatives to improve QC and AD departments. Effectively communicate and present results, observations, solutions, and scientific strategies to internal and external stakeholders. Perform other duties, as assigned based on business needs. Up to 15% travel to support CDMO projects or business development activities. Qualifications
Master’s degree with 4 years of relevant experience, or Bachelor’s degree with 7 years of relevant experience. Degree in Molecular Biology, Biochemistry, or related scientific field. Experience in gene and cell therapy by way of Viral Vectors. Experience with CE-SDS and/or AUC and/or SEC-MALS HPLC. Familiar with Good Documentation Practices, Data Integrity, ALCOA+. Experience following Standard Operating Procedures or protocols. Strong interpersonal, verbal, and written communication skills. Experience as a trainer is a plus. Ability to problem solve, and work independently and as part of a team. Experience with Microsoft Office; experience with statistics, coding, programming, troubleshooting, and/or data management software is a plus. Compensation
The salary range, dependent upon experience level, is $75,000 - $100,000 annually. Equal Opportunity
GenScript USA Inc./ProBio Inc. is an equal opportunity/affirmative action employer. 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/civil partnership status, genetic information, citizenship status, or other protected characteristics. The company maintains a drug-free workplace. Applications will be contacted through verified application sources. Candidates are advised to avoid sharing personal information via unverified channels.
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GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group with a presence across North America, Europe, the Greater China, and Asia Pacific. ProBio provides end-to-end CDMO services from drug discovery to commercialization in cell and gene therapy, vaccine, biologics discovery and antibody protein drug, including CMC support for plasmid and virus IND filing and clinical/commercial manufacturing. Job Scope
The position reports to the Sr. QC Manager and is suited for a professional with extensive technical knowledge and a proven track record of developing and executing processes for GMP manufacturing of a wide range of clinical trial materials, and for participating in technology transfer. This role offers the opportunity to lead and evolve QC-Operations within a CDMO setting, supporting a broad portfolio and advancing manufacturing capabilities to deliver client projects that impact patients’ lives. Responsibilities
Support in the setup, development and optimization of GMP QC-Operations Laboratories, primarily launching and supporting Non-GMP and GMP AAV production. Support QC-Operations initiatives including equipment qualification, method development, method validation, and tech-transfer. Support method lifecycle initiatives. Author and/or review protocols, executions and reporting for developed methods. Perform a wide range of analytical tests, including CE-SDS, AUC, ELISA, ddPCR, HPLC, and DNA Sequencing/Analysis. Develop and lead optimization initiatives to improve QC and AD departments. Effectively communicate and present results, observations, solutions, and scientific strategies to internal and external stakeholders. Perform other duties, as assigned based on business needs. Up to 15% travel to support CDMO projects or business development activities. Qualifications
Master’s degree with 4 years of relevant experience, or Bachelor’s degree with 7 years of relevant experience. Degree in Molecular Biology, Biochemistry, or related scientific field. Experience in gene and cell therapy by way of Viral Vectors. Experience with CE-SDS and/or AUC and/or SEC-MALS HPLC. Familiar with Good Documentation Practices, Data Integrity, ALCOA+. Experience following Standard Operating Procedures or protocols. Strong interpersonal, verbal, and written communication skills. Experience as a trainer is a plus. Ability to problem solve, and work independently and as part of a team. Experience with Microsoft Office; experience with statistics, coding, programming, troubleshooting, and/or data management software is a plus. Compensation
The salary range, dependent upon experience level, is $75,000 - $100,000 annually. Equal Opportunity
GenScript USA Inc./ProBio Inc. is an equal opportunity/affirmative action employer. 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/civil partnership status, genetic information, citizenship status, or other protected characteristics. The company maintains a drug-free workplace. Applications will be contacted through verified application sources. Candidates are advised to avoid sharing personal information via unverified channels.
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