Scientist, Analytical Development

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. 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:

• Apply knowledge of bio separation techniques to support method development, troubleshooting, and process characterization
• Support the establishment, 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.
• Own method lifecycle management activities, including authoring and reviewing protocols, reports, and technical documentation.
• 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 UPLC/HPLC, CE-SDS, and analytical ultracentrifugation (AUC).
• Drive continuous improvement initiatives across AD and QC, identifying opportunities to enhance assay robustness, efficiency, and data quality.
• Analyze complex datasets and effectively communicate results, observations, and recommendations to internal and external stakeholders
• Collaborate cross-functionally with Process Development, Manufacturing, and Quality teams to support product and process advancement.
• Perform other duties as assigned based on business needs
• Up to 15% traveling to support CDMO projects or business development activities.

Qualifications:

•  Master’s degree with 2+ years of relevant industry experience, or Bachelor’s degree with 5+ years, or Ph.D. with 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 UPLC/HPLC, CE-SDS and/or AUC; experience working with MALS and/or CAD detectors is a plus.
• Experience executing assays in accordance with Standard Operating Procedures and protocols in a regulated or controlled environment.
• Strong problem-solving skills with the ability to work independently and collaboratively in a fast-paced environment.
•  Familiar with principles of Good Documentation Practices, Data Integrity, and ALCOA+.
• Strong interpersonal, verbal, and written communication skills.
•  Experience with Next-Generation Sequencing (NGS) is a plus.
•  Experience with Microsoft Office tools. Experience with statistics, coding, programming, troubleshooting, and/or data management software is a plus.

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

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