QC Scientist – Raw Materials
Listed on 2026-02-07
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Healthcare
Data Scientist -
Quality Assurance - QA/QC
Data Analyst
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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 Pro Bio Pro Bio 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.
Pro Bio’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
- 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, 21
CFR
210, 21
CFR
211, 21
CFR
600, 21
CFR 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/Pro Bio 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…
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