GenScript
Job Overview
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. The company’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 in cell and gene therapy, vaccine, biologics discovery and antibody protein drug, supporting IND filings through clinical and commercial manufacturing. This role is onsite in Pennington, New Jersey and reports to the Sr. QC Raw Materials Manager. The position is suited for a professional with technical knowledge and experience in developing and carrying out GMP manufacturing processes for a wide range of clinical trial materials and technology transfer within a CDMO environment. There is a significant opportunity to contribute to a broad portfolio and advance manufacturing capabilities to deliver client projects that transform patients\' lives. Key Responsibilities
Methods of testing within a GMP-regulated environment including FTIR Microscopy, Raman, UHPLC, physical testing, and wet chemistry. Manage the sampling and disposition of raw materials in a regulated cleanroom environment. Perform manufacturing consumable and processing aids inspections and release. Maintain sample and reference material inventory. Qualify and validate new laboratory instrumentation and equipment. Author and review new specifications, qualification/validation reports for raw materials and consumables. Author and revise procedural SOPs, testing methods, and material specifications. Up to 15% travel to support CDMO projects or business development activities. Qualifications
Master’s degree with 2-3 years of relevant work experience, or Bachelor’s degree with 4-6 years of relevant work experience. Degrees in Molecular Biology, Biochemistry, Microbiology or related scientific field. Experience with SAP, LIMS, ELN, Veeva Vault Quality Document Management System or equivalent is desirable. Hands-on experience in sampling raw materials in Grade D or Grade C, ISO-compliant environments. Knowledge of global pharmacopeia testing requirements (USP/NF, EP, JP). Knowledge of global regulatory requirements for raw material testing and release (FDA, EMA, 21 CFR 210/211/600, 21 CFR Part 11, Eudralex Volume 4 ATMPs). Experience in authoring, revising, and reviewing documents such as testing methods, SOPs, and material specifications. Experience in Quality Risk Management and Quality Events (Deviations, Change Controls, Quality Audits, Laboratory Testing Investigations). Experience with osmolality testing, Karl Fischer, HIAC/MFI, Solo-VPE, electrophoresis is a plus; experience with method development and qualification/validation for analytical testing methods per USP
, USP
, ICH Q2(R2). Ability to problem solve and work independently and as part of a team; strong interpersonal, verbal, and written communication skills. Note: This role is based fully onsite in Pennington, New Jersey. The estimated salary range is $75,000 - $90,000 annually. Equal Opportunity and Workplace Information
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, or any other characteristic protected by law. GenScript USA Inc./ProBio Inc. maintains a drug-free workplace.
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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. The company’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 in cell and gene therapy, vaccine, biologics discovery and antibody protein drug, supporting IND filings through clinical and commercial manufacturing. This role is onsite in Pennington, New Jersey and reports to the Sr. QC Raw Materials Manager. The position is suited for a professional with technical knowledge and experience in developing and carrying out GMP manufacturing processes for a wide range of clinical trial materials and technology transfer within a CDMO environment. There is a significant opportunity to contribute to a broad portfolio and advance manufacturing capabilities to deliver client projects that transform patients\' lives. Key Responsibilities
Methods of testing within a GMP-regulated environment including FTIR Microscopy, Raman, UHPLC, physical testing, and wet chemistry. Manage the sampling and disposition of raw materials in a regulated cleanroom environment. Perform manufacturing consumable and processing aids inspections and release. Maintain sample and reference material inventory. Qualify and validate new laboratory instrumentation and equipment. Author and review new specifications, qualification/validation reports for raw materials and consumables. Author and revise procedural SOPs, testing methods, and material specifications. Up to 15% travel to support CDMO projects or business development activities. Qualifications
Master’s degree with 2-3 years of relevant work experience, or Bachelor’s degree with 4-6 years of relevant work experience. Degrees in Molecular Biology, Biochemistry, Microbiology or related scientific field. Experience with SAP, LIMS, ELN, Veeva Vault Quality Document Management System or equivalent is desirable. Hands-on experience in sampling raw materials in Grade D or Grade C, ISO-compliant environments. Knowledge of global pharmacopeia testing requirements (USP/NF, EP, JP). Knowledge of global regulatory requirements for raw material testing and release (FDA, EMA, 21 CFR 210/211/600, 21 CFR Part 11, Eudralex Volume 4 ATMPs). Experience in authoring, revising, and reviewing documents such as testing methods, SOPs, and material specifications. Experience in Quality Risk Management and Quality Events (Deviations, Change Controls, Quality Audits, Laboratory Testing Investigations). Experience with osmolality testing, Karl Fischer, HIAC/MFI, Solo-VPE, electrophoresis is a plus; experience with method development and qualification/validation for analytical testing methods per USP
, USP
, ICH Q2(R2). Ability to problem solve and work independently and as part of a team; strong interpersonal, verbal, and written communication skills. Note: This role is based fully onsite in Pennington, New Jersey. The estimated salary range is $75,000 - $90,000 annually. Equal Opportunity and Workplace Information
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, or any other characteristic protected by law. GenScript USA Inc./ProBio Inc. maintains a drug-free workplace.
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