Pearl River, NY
Production Associate
Job Description
Work with the production team to supply clinical and/or commercial product supply.
Maintain and clean production equipment. Carry out all aspects of the NuBiyota drug product manufacturing process, including (but not limited to): o Media/Material preparation o Anaerobic bacterial culture work o Lyophilization o Encapsulation o Product packaging o Sample collection for QC and in-process testing Author and adhere to standard operating procedures (SOPs).
Ensure compliance with institutional, state and federal regulatory policies, procedures, directives and mandates, and meet future FDA/ EMEA inspections.
Meet GMP and GLP requirements and principles.
Complete paperwork and associated documentation in compliance with GMP guidelines.
Process scale up.
Design and build GMP pilot plant for clinical supply.
Perform other tasks as required
DESIRABLE/PREFERRED
Recent graduate with a Science background (Biology, Microbiology, etc.).
Experience with Microsoft 365 and SharePoint.
Desire to work in the microbiome or biotechnology industries
Maintain and clean production equipment. Carry out all aspects of the NuBiyota drug product manufacturing process, including (but not limited to): o Media/Material preparation o Anaerobic bacterial culture work o Lyophilization o Encapsulation o Product packaging o Sample collection for QC and in-process testing Author and adhere to standard operating procedures (SOPs).
Ensure compliance with institutional, state and federal regulatory policies, procedures, directives and mandates, and meet future FDA/ EMEA inspections.
Meet GMP and GLP requirements and principles.
Complete paperwork and associated documentation in compliance with GMP guidelines.
Process scale up.
Design and build GMP pilot plant for clinical supply.
Perform other tasks as required
DESIRABLE/PREFERRED
Recent graduate with a Science background (Biology, Microbiology, etc.).
Experience with Microsoft 365 and SharePoint.
Desire to work in the microbiome or biotechnology industries
Recommended Skills
- Biology
- Biotechnology
- Clinical Works
- Industrial Production
- Microbiology
- Microsoft Share Point
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