Associate Scientist, Cell Therapy Quality Control and Analytical Risk Management

Associate Scientist, Cell Therapy Quality Control and Analytical Risk Management

Work Location: Summit West, NJ

Assignment Duration: 06 Months

Work Schedule: Monday-Friday: 8 AM-5 PM

Work Arrangement: Onsite

The Associate Scientist (Contractor) is responsible for data collection, analysis, and verification of cell therapy quality control and analytical development data. This role works collaboratively across multiple departments to support risk management initiatives, ensure data integrity, and drive continuous improvement.

• Conduct comprehensive data analysis of cell therapy QC and analytical development datasets.
• Review GMP documentation and perform data verification to ensure data accuracy and integrity.
• Support document revision, project work, CAPA, deviation/investigation-related tasks, and continuous improvement efforts.
• Collaborate with cross-functional teams (Quality Control, Product Quality, Analytical Science & Technology) to support business needs and risk management initiatives.
• Train analysts on general job duties and data management practices as needed.
• Identify and communicate risks and opportunities based on data insights.
• Prepare and present data summaries, reports, and recommendations to stakeholders.
• Maintain compliance with regulatory and quality standards in all data-related activities.
• Perform other tasks as assigned and adapt quickly to changing priorities in a fast-paced environment.

• Bachelor's degree preferred in science (Analytical Chemistry, Biochemistry, Life Sciences, or related field). Associate's degree or equivalent combination of education and experience may be considered.
• 2+ years of relevant data analysis, analytical development, or QC experience, preferably in a regulated environment.
• Demonstrated experience with basic laboratory techniques and basic laboratory safety practices.
• Prior experience in cell and molecular biology techniques (e.g., cell-based assays, flow cytometry, qPCR, aseptic technique) is preferred.
• Experience in analytical chemistry and/or quality control, preferably in the biopharmaceutical or cell therapy industry, is a plus.
• Familiarity with regulatory requirements and quality standards in a GMP environment is preferred.
• Strong data analysis skills, with proficiency in relevant software and tools (e.g., Excel, statistical analysis software).
• Excellent attention to detail and demonstrated organizational skills.
• Ability to communicate effectively with peers and management.
• Ability to work collaboratively across multiple functions and departments.
• Ability to work in a fast-paced team environment, meet deadlines, and prioritize work.