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Researcher I - Biomanufacturing and Product Quality Assessment

Silver Spring, MDOnsiteFull TimePosted 1 month agoVisa sponsorship available

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Required skills

biologic product quality
therapeutic proteins
analytical technologies
bioprocess equipment
chromatography
rapid microbial detection
light scattering
protein stability
bioreactor
FPLC

Nice to have

HPLC/UHPLC
MALS
protein purification
protein stability instrumentation
aseptic CHO culture
bacterial suspension culture

Role summary

The FDA is seeking a Researcher I to support biomanufacturing and product quality assessment. This role involves testing therapeutic proteins, integrating analytical technologies with bioprocess equipment, and operating a suite of instruments including chromatography, microbial detection, light scattering, and protein stability analyzers. Responsibilities include cell culture, data analysis, equipment maintenance, and preparing reports and presentations. A BS degree with 4 years of relevant experience or an MS with 1 year is required, preferably in a scientific or engineering field related to biopharmaceuticals.

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

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