Job Description :
- 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.
- May support local, regional, and global program initiatives.
Responsibilities :
- 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.
- May support local, regional, and global program initiatives.
Qualifications : Education Bachelor’s degree / Master’s degree in a relevant biological area (Bacteriology, Biology, Microbiology, Virology).
Either Candidates should have a biological education with 1-3 years ELISA experience in a lab setting (not college) Or other science degree with 2-3 years’ experience in an animal health biologics setting with ELISA.
Required Experience and Skills
- 1-3 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 *Note* :
- This is an Onsite role at De Soto, KS for 40 hrs / week. Flexible work schedule : 8am-5pm / 9am-6pm / 8am-4pm / 6am-2pm / 7am-3pm.
- The possibility of conversion to permanent employee or extension depending upon the performance.
- Managers are open to non-local candidates who are comfortable relocating at their expense.
- Panel interviews will be conducted for this role for approximately 60 minutes.
30+ days ago