Cognizance Technologies, LLC | Full time
Researcher I - Biomanufacturing and Product Quality Assessment
Silver Spring, United States | Posted on 09/29/2026
Support FDA research on biologic product quality by testing therapeutic proteins and helping integrate new analytical technologies with bioprocess equipment. You will work across a broad instrument suite — chromatography, rapid microbial detection, light scattering and protein stability — and help connect analytical tools to bioreactor and FPLC setups for online sampling.
Requirements
Key responsibilities
- Perform analytical testing on monoclonal antibodies, therapeutic proteins and other protein products; compile sample information into multiple databases.
- Operate and maintain U/HPLC, rapid microbial detection and identification systems, and multimodal spectrophotometers, including for in-line and on-line measurement development.
- Operate and maintain protein purification systems, protein stability analyzers, microfluidic capillary systems and multi-angle light scattering (MALS) systems.
- Culture mammalian (CHO) and bacterial cells in suspension using aseptic technique.
- Help integrate existing technologies with bioreactor and FPLC setups for online sampling.
- Collect, process and analyze sample and test data from multiple sources.
- Help maintain and repair equipment and keep inventories of supplies and instruments current.
- Prepare Word summaries and PowerPoint presentations; meet weekly with the program lead and provide scheduled status reports.
- Contribute to manuscripts, technical reports and white papers.
- Complete all mandatory FDA training and maintain required credentials.
Required qualifications
- BA/BS in biochemistry, cell biology, biotechnology, chemistry, chemical or bioengineering, or a related field, with 4 years of relevant experience; or an MS with 1 year.
- Experience in biopharmaceutical manufacturing, quality analytics, biotechnology R&D or a related field.
Preferred qualifications
- MS or other advanced degree (highly preferred).
- Hands-on experience with HPLC/UHPLC, MALS, protein purification (e.g., FPLC) or protein stability instrumentation.
- Aseptic CHO or bacterial suspension culture experience.
- Exposure to process analytical technology or online bioprocess sampling.
- PPO/HMO Health Plan (includes medical, dental, and vision)