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Manufacturing Associate II/III

1 month ago

Rockville, United States Joulé Full time

Title: Manufacturing Associate II/III
Location: Rockville, MD
Schedule: M-F 8am-5pm
Type: Contract to potential hire depending on performance
Start date: Immediate

Our client is a privately held company that leverages its expertise in synthetic biology and immunological drug development to create novel cellular-based immune therapies. They are focused on developing immunological-based biological medicines using a unique and proprietary oral biologics delivery platform. Their drug development focus is driven by new microbiome-related discoveries enabling the development of targeted, immune modulatory drugs for treating inflammation, autoimmunity, cancer, and infection.

They are seeking a Manufacturing Associate with a background in fermentation to work in their Rockville, Maryland laboratory. As a Manufacturing Associate, you will play a crucial role in the production of high-quality bioproducts by supporting various aspects of the fermentation process. This position offers an exciting opportunity to contribute to innovative biotechnological solutions and work in a collaborative environment

Responsibilities: Operate and monitor fermentation equipment, ensuring optimal conditions for bacterial growth and product yield. Follow standard operating procedures (SOPs) and protocols to maintain consistency and quality
Conduct regular quality checks on fermentation batches, including sampling, testing, and recording data to ensure compliance with quality standards and regulatory requirements.
Independently set and execute bioreactor runs and purification operations to develop, optimize, and scale up fermentation & purification unit operations
Develop subject matter expertise in internal scientific areas such as bacterial scale-up, freeze-drying and spore-development
Present data at internal meetings, work with research groups, and author scientific reports for internal documentation and external presentation
Author, manage, and own master batch records, SOPs, and Policy documents
Contribute to the authorship of INDs, Regulatory updates, and Grant reports

Requirements: Degree (BS or MS) in chemical engineering, biochemistry, microbiology, or related disciplines
1-4 years of experience working directly in the process development or bacterial fermentation areas
Background in bacterial fermentation with experience operating small to medium-scale (1-1000L) bioreactors
Background in bacterial growth optimization, freeze-drying, and other processing
Background in anaerobic microbiology and spore biology preferred but not required.
Background in yeast and mammalian cultures preferred but not required.
Experience in bench-scale protein purification
Experience with JMP, and other statistical tools
Familiarity with good manufacturing practices (GMP)
Comfort with collaboration in a fast-paced team-based environment

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