Job Description

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 ProBio:

ProBio Inc. is a New Jersey-based fully integrated contract development and manufacturing organization (CDMO) dedicated to accelerating the discovery, development, and manufacturing of life-changing medicines. We partner with biotech and pharmaceutical companies to drive innovation by leveraging our multi-disciplinary expertise and proprietary platform technologies to advance the promise of cell and gene therapies. With facilities in the US, specifically our 128,000-square-foot Hopewell site, ProBio integrates stringent quality control and robust quality assurance at every step of the way from process development to clinical and commercial-scale manufacturing. Our team is committed to ensuring the success of our client’s breakthrough therapies by providing seamless tech transfer, rigorous quality control, and comprehensive manufacturing support for plasmid DNA and viral vectors. At ProBio, we are passionate in realizing the potential of your breakthrough discovery to treat diseases and improve lives.

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 $90k - $120k based on skill set and experience.

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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.