Job Description: 100% onsite
Work Schedule: M-F(normal business hours)
Note: Summit, NJ is primary site. Will require flexibility to travel to New Brunswick depending on project load and resource requirement
Position Summary:
The Assistant Scientist position will be part of the Biologics Downstream Development department in Summit, NJ that is responsible for early and late stage process development of Client’ growing biologics pipeline. The candidate will be responsible for developing efficient, robust, and scalable purification processes for therapeutic biologics. The candidate will focus on chromatography and filtration unit operations.
Key Responsibilities:

• Perform hands-on laboratory experiments involving filtration and chromatography process development using AKTA-Unicorn chromatography systems.
• Downstream process development, process optimization, process characterization, and tech transfer.
• Support process scale-up activities in the pilot plant, clinical and commercial manufacturing sites.
• Prepare/review technical documents including development/tech transfer reports and CMC regulatory submissions
• Participate on cross-functional teams to progress both early and late stage drug candidates.
• Perform experiments to evaluate and implement innovative next generation technologies.

Qualifications & Experience:

• B.S. in Chemical/Biochemical Engineering, Biotechnology, Biochemistry, or related biologics fields with 0 - 2 years of industry experience is required
• Prior hands-on experience with downstream process development, including preparative chromatography, ultrafiltration/diafiltration, viral inactivation, viral filtration and high throughput robotic platforms is desired.
• Knowledge of statistical experimental design and data analysis is desired.
• Knowledge of cGMPs as applied to process development and scale up is desired.
• Sound oral and written communication skills.
• Ability to work collaboratively in a team environment

Additional Job Requirements:
Position Handles Hazardous Materials