Job Scope:
The position reports to the Sr. QC Manager, is ideally suited for a professional with extensive technical knowledge, and a proven track record of 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 lead and evolve 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.
Responsibilities:
- Support the set-up, development and optimization of GMP QC-Analytics Lab.
- Generate and characterize engineered cell lines, including production of MCB and WCB for cell-based assay development.
- Develop, optimize, and execute molecular and cellular assays to assess vector performance using qPCR/ddPCR based assay, Western blot, ELISA and Flow cytometry.
- Independently plan, perform, analyze, and interpret experiments, present clear data summaries and recommendations to cross-functional teams and clients.
- Prepare technical reports, study summaries, and presentation materials to support decision-making.
- Collaborate closely with other teams in CMC and coordinate cross-functional activities to support tech transfer and CMC activities.
- Drive continuous improvement by identifying and implementing new tools, technologies, and best practices in CGT CMC analytics.
- Ensure compliance with BSL-2 biosafety standards, cGMP, and applicable regulatory requirements.
- May travel up to 10% to support CDMO projects or business development activities.
Qualifications:
- PHD with 2+ years or M.S. with 3+ years in Molecular Biology, Cell & Gene Therapy, Biochemistry, or related field.
- Demonstrated hands-on experience in lentiviral vector release testing and characterization (required).
- Expertise in molecular and cell biology techniques, including qPCR, ddPCR, ELISA or DNA Sequencing/Analysis.
- Hands-on experience with Western blotting and flow cytometry for protein and cell-based analyses.
- Exposure to NGS-based methods for vector or genome characterization is a plus.
- Working knowledge of Good Documentation Practices, data integrity, and ALCOA+ principles.
- Strong problem-solving skills with the ability to work independently and collaboratively in a team environment.
- Excellent interpersonal, verbal, and written communication skills.
- Familiarity with regulatory requirements and guidance from agencies such as FDA and ICH; experience with EU Annex 1 and laboratory audits is a plus.
Compensation: The salary range, dependent upon experience level, is $90,000 - $120,000 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.
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What We Do
Founded in 2002 and listed on the Hong Kong Stock Exchange in 2015, GenScript has an established global presence across Greater China, North America, the EU, and Asia Pacific. Today, over 300,000 customers from over 160 countries and regions worldwide have used GenScript’s premier, convenient, and reliable products and services. GenScript currently has over 5,000 employees globally, 33% holding master’s and/or Ph.D. degrees. In addition, GenScript has a number of leading commercial technologies developed in the fields of synthetic biology, immunotherapy, antibody design, chemical synthesis, and bioinformatics, including more than 100 patents and over 270 patent applications. As of June 2022, GenScript's products and services have been cited by 74,700 scientific papers worldwide. GenScript is committed to striving toward its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology.
