ABOUT GENSCRIPT

GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript’s businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.
GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology.

QUALIFICATIONS:

• Master’s degree with 2-3 years of relevant work experience, or Bachelor’s degree with 4-6 years of relevant work experience. Degree 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 a Grade D or Grade C, ISO complaint environment.
• Knowledge of global pharmacopeia testing requirements from USP/NF, Pharmaco Europa/EP, JP.
• Expertise in global regulatory requirements for raw material testing and release from FDA, EMA, 21CFR210, 21CFR211, 21CFR600, 21CFR Part 11, Eudralex Volume 4 ATMPs.
• Experience in authoring, revising, and reviewing document such as testing methods, SOPs, material specifications.
• Experience in Quality Risk Management and Quality Events such as Deviations, Change Controls, Quality Audits, Laboratory Testing Investigations.
• Ability to problem solve and work independently and as part of a team.
• Strong interpersonal, verbal, and written communication skills.
  Please note that this role is based fully onsite in Pennington, New Jersey. The estimated salary range is $75,000 - $90,000 annually.
  

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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

• Methods of testing within a GMP-regulated environment that include FTIR Microscopy, Raman, UHPLC, physical testing, wet chemistry.
• Experience with Osmolality testing, Karl Fischer, HIAC/MFI, Solo-VPE, Electrophoresis is a plus.
• Experience in the method development and qualification/validation processes for analytical testing methods according to USP <1225>, USP <1226>, ICHQ2R2.
• 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, material specifications.
• Up to 15% traveling to support CDMO projects or business development activities.