Scientist III, Analytical Development

GenScript/ProBio•Pennington, NJ

1d•$90,000 - $120,000

About The Position

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.

Requirements

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 Microsoft Office tools.

Nice To Haves

experience in gene and cell therapy is a plus.
experience working with MALS and/or CAD detectors is a plus.
Experience with Next-Generation Sequencing (NGS) is a plus.
Experience with statistics, coding, programming, troubleshooting, and/or data management software is a plus.

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.