CMC Analytical Scientist

About ProBio

ProBio, a subsidiary of GenScript, is a global CDMO offering end-to-end services from discovery to GMP for plasmids, antibodies, and cell & gene therapies. We bring together multidisciplinary expertise to accelerate development and manufacturing through customized, and comprehensive services. ProBio has established companies in the United States, the Netherlands, South Korea, and China (Hong Kong, Shanghai, and Nanjing) and other regions to serve global customers, and has helped customers in the United States, Europe, Asia Pacific and other regions obtain more than 150 IND approvals since October 2017

Position Overview:

The position reports to the Sr. Scientist, 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 maintenance of a 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.

Qualifications:

• Ph.D. 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.

Pay range is estimated between $80k - $110k based on skill set and experience.

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