What are the responsibilities and job description for the Researcher I - Biomanufacturing and Product Quality Assessment at FDA CDER OPQR position at Women In Science?
Cognizance Technologies
Laurel, MD
Job posting number: #7372786 (Ref:TO4ResearcherI)
Posted: October 16, 2026
Salary / Pay Rate: $90,000 - $100,000
Application Deadline: Open Until Filled
Job Description
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.
Benefits
PPO/HMO Health Plan (includes medical, dental, and vision)
401K Retirement Plan
Paid Time Off (PTO)
Apply Now
Please mention to the employer that you saw this ad on WomenInScience.com
More Info
Job posting number: #7372786 (Ref:TO4ResearcherI) Application Deadline: Open Until Filled Employer Location: Cognizance Technologies
Gaithersburg,Maryland
United States More jobs from this employer Institution Website
Laurel, MD
Job posting number: #7372786 (Ref:TO4ResearcherI)
Posted: October 16, 2026
Salary / Pay Rate: $90,000 - $100,000
Application Deadline: Open Until Filled
Job Description
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.
Benefits
PPO/HMO Health Plan (includes medical, dental, and vision)
401K Retirement Plan
Paid Time Off (PTO)
Apply Now
Please mention to the employer that you saw this ad on WomenInScience.com
- Share this job:
- [Save this Job]
More Info
Job posting number: #7372786 (Ref:TO4ResearcherI) Application Deadline: Open Until Filled Employer Location: Cognizance Technologies
Gaithersburg,Maryland
United States More jobs from this employer Institution Website
Salary : $90,000 - $100,000