Engineering - Assistant/Associate Scientist
TechDigital Corporation
Summit, NJ
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JOB DETAILS
SKILLS
Biochemistry, Biological Processes, Biotech and Pharmaceutical, Candidate Pipeline, Chemical Engineering, Chromatographic Systems, Chromatography, Communication Skills, Cross-Functional, Current Good Manufacturing Practice (cGMP), Data Analysis, Develop and Maintain Customers, Experiment Design, High Throughput, Manufacturing, Pilot Plant, Presentation/Verbal Skills, Process Development, Process Improvement, Regulatory Reports, Regulatory Submissions, Sales Pipeline, Team Player, Technical Writing, Unicorn Library Management System, Writing Skills
LOCATION
Summit, NJ
POSTED
30+ days ago
100% onsite
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
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
Lab w/o blood & animal
About the Company
T
TechDigital Corporation
COMPANY SIZE
100 to 499 employeesINDUSTRY
Other/Not Classified