GenScript USA Inc.
Scientist, Analytical Development Pennington, NJ
GenScript USA Inc., Trenton, New Jersey, United States
Overview
GenScript Biotech Corporation and ProBio seek a professional to support GMP QC-Operations Laboratories, primarily launching and supporting Non-GMP and GMP AAV production. 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 carrying out processes for GMP manufacturing of clinical trial materials and participating in technology transfer. There is an opportunity to lead and evolve this function within a CDMO business, supporting a broad portfolio and advancing manufacturing capabilities to deliver products to client projects that transform lives of patients. Responsibilities
Support in the set-up, development and optimization of GMP QC-Operations Laboratories, primarily launching and support 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% traveling to support CDMO projects or business development activities. Qualifications
Master’s degree with 4 years of relevant work experience, or Bachelor’s degree with 7 years of relevant work experience. Degree in Molecular Biology, Biochemistry, or related scientific field. Experience in gene and cell therapy by way of Viral Vectors. Experience working with CE-SDS and/or AUC and/or SEC-MALS HPLC. Familiar with principles of 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 tools. 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 Employment 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 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./ProBio Inc. maintains a drug-free workplace.
#J-18808-Ljbffr
GenScript Biotech Corporation and ProBio seek a professional to support GMP QC-Operations Laboratories, primarily launching and supporting Non-GMP and GMP AAV production. 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 carrying out processes for GMP manufacturing of clinical trial materials and participating in technology transfer. There is an opportunity to lead and evolve this function within a CDMO business, supporting a broad portfolio and advancing manufacturing capabilities to deliver products to client projects that transform lives of patients. Responsibilities
Support in the set-up, development and optimization of GMP QC-Operations Laboratories, primarily launching and support 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% traveling to support CDMO projects or business development activities. Qualifications
Master’s degree with 4 years of relevant work experience, or Bachelor’s degree with 7 years of relevant work experience. Degree in Molecular Biology, Biochemistry, or related scientific field. Experience in gene and cell therapy by way of Viral Vectors. Experience working with CE-SDS and/or AUC and/or SEC-MALS HPLC. Familiar with principles of 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 tools. 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 Employment 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 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./ProBio Inc. maintains a drug-free workplace.
#J-18808-Ljbffr