- Assists in the maintenance of the reference management program for US biologics sites.
- Maintains compliance according to USDA guidelines and requirements for reference standards and in vitro potency tests.
- Conducts in vitro testing for stability of reference standards of pre- and post-licensure products.
- Prepares and tests small-scale vaccines to support formulation of new reference standards.
- Supports the formulation, dispense and testing of new reference standards as part of the reference qualification process.
- Participates and collaborates in cross-functional teams with colleagues from R&D, Biotechnology Solutions-Analytics, Production, Quality Control, and Regulatory Affairs to support qualification of new reference standards.
- May assist in the preparation of protocols or reports for submission to USDA.
- May participate in critical reagent qualification studies.
- May provide technical support for approved Quality Control assays.
Quals
Education
Bachelor's degree / Master's degree in a relevant biological area (Bacteriology, Biology, Microbiology, Virology).
Either Candidates should have a biological education with - years ELISA experience in a lab setting (not college but industry).
Required Experience and Skills
- years laboratory experience with ELISA, preferably in Animal Health / industry.
- Detail-oriented with good documentation skills
- Ability to conduct scientific experiments, interpret results, and communicate with relevant team members and stakeholders.
- Effective written and oral communication
- Experience with Microsoft Office programs : Excel, PowerPoint, and Word
Preferred Experience and Skills
- Ability to independently design scientific experiments.
- Experience working in an R&D or Quality Control laboratory.
- Experience developing, working with, and troubleshooting in vitro analytical tests mainly ELISA
- Knowledgeable of USDA regulations for biological products
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