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Process Development Engineer
1 month ago
Title: Process Development Engineer
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 development engineer with a background in bacterial fermentation to work in their Rockville, Maryland laboratory. This position offers a unique opportunity for entrepreneurial minded scientists to advance skills and experience necessary for a successful career in the biotechnology industry. The process development engineer will support strategies to create production processes for new synthetic biology-based cellular medicines. The position will focus on process optimization, process scale up, and GMP manufacturing.
Responsibilities: Design experiments, execute laboratory scale processes, present data in internal meetings, and contribute to the formulation of process strategies
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 (MS and/or PhD) 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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