Associate Scientist, Analytical Operation

GenScript/ProBio • Pennington, NJ

1d • Onsite

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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 with statistics, coding, programming, troubleshooting, and/or data management software is a plus.

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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree