QC Scientist I - Raw Materials

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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. About ProBio ProBio proactively provides end-to-end CDMO service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in cell and gene therapy, vaccine, biologics discovery and antibody protein drug to accelerate drug development for customers. ProBio’s total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing.

Job Scope

The position reports to the Sr. QC Raw Materials Manager, is ideally suited for a professional with technical knowledge, and exposure to developing and carrying out processes, that are suitable for use in GMP manufacturing of a wide range of clinical trial materials, and participating in the technology transfer. There is a great opportunity to learn this function within a CDMO business, to support a broad portfolio and advance the manufacturing capabilities to deliver products to the client projects that transform the lives of patients.

Key Responsibilities

• Methods of testing 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 , USP , 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.

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.

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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.

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