BioSpace
Company Overview
GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group founded in 2002. With a presence across North America, Europe, the Greater China, and Asia Pacific, GenScript’s businesses include Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy. GenScript is committed to becoming the most reliable biotech company in the world to improve human health. ProBio provides end‑to‑end CDMO services for cell and gene therapy, vaccine, biologics discovery, and antibody protein drugs, covering CMC of plasmid and virus for IND filing, clinical manufacturing, and commercial production.
Job Scope The position reports to the Sr. QC Manager and is ideally suited for a professional with extensive technical knowledge and a proven track record of developing and carrying out processes suitable for use in GMP manufacturing of a wide range of clinical trial materials. The role includes participation in technology transfer and offers the 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 patients’ lives.
Responsibilities
Support set‑up, 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, execution 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.
Travel up to 15% 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, especially viral vectors.
Experience with CE‑SDS and/or AUC and/or SEC‑MALS HPLC.
Familiar with Good Documentation Practices, Data Integrity, ALCOA+ principles.
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.
Job Details
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Research, Analyst, and Information Technology
Equal Opportunity Employer 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. 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.
Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.
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Job Scope The position reports to the Sr. QC Manager and is ideally suited for a professional with extensive technical knowledge and a proven track record of developing and carrying out processes suitable for use in GMP manufacturing of a wide range of clinical trial materials. The role includes participation in technology transfer and offers the 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 patients’ lives.
Responsibilities
Support set‑up, 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, execution 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.
Travel up to 15% 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, especially viral vectors.
Experience with CE‑SDS and/or AUC and/or SEC‑MALS HPLC.
Familiar with Good Documentation Practices, Data Integrity, ALCOA+ principles.
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.
Job Details
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Research, Analyst, and Information Technology
Equal Opportunity Employer 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. 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.
Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.
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