Associate Scientist, Analytical Operation

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

Job Scope:

We are seeking an enthusiastic and dedicated Associate Scientist to join our team at ProBio US Site in Pennington, New Jersey. The position reports to the Sr. Scientist, Analytical Operations, 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.

Location: Pennington, New Jersey, US

Responsibilities:

• Perform a wide range of analytical tests, including UV-Spectrophotometry, qPCR, ELISA, HPLC, Endotoxin, MicroBCA, Electrophoresis, and DNA Sequencing/Analysis.
• Responsible for following cGMP in carrying out functions related to QC testing.
• Support development and optimization of Analytical Development (AD) and Quality Control (QC) laboratories to enable both Non-GMP and GMP testing.
• Design, develop, and execute analytical methods, including method development, method qualification/validation, technology transfer, and product testing.
• Support procedure lifecycle activities, including authoring and reviewing Standard Operating Procedures (SOPs) and associated forms.
• Perform and interpret a broad range of analytical assays, including but not limited to qPCR, ddPCR, ELISA and HPLC.
• Drive continuous improvement initiatives across AD and QC, identifying opportunities to enhance assay robustness, efficiency, and data quality.
• Collaborate cross-functionally with Process Development, Manufacturing, and Quality teams to support product and process advancement.
• Ensure compliance with cGMP and regulatory requirements

Qualifications:

• Bachelor’s degree or master's degree with 1+ years or relevant experience.
• Degree in Chemistry, Biochemistry, Molecular Biology, or related scientific field; experience in gene and cell therapy is a plus.
• Hands-on experience with analytical techniques such as qPCR, ELISA, UPLC/HPLC, CE-SDS is a plus.
• Experience executing assays in accordance with Standard Operating Procedures and protocols in a regulated or controlled environment.
• Familiar with principles of Good Documentation Practices, Data Integrity, and ALCOA+.
• Strong interpersonal, verbal, and written communication skills
• Experience with Microsoft Office tools. Experience with statistics, coding, programming, troubleshooting, and/or data management software is a plus.

The estimated pay range for the role is between $60,000 - $80,000 based on qualifications and experience.

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