| Job Description | The Senior Bioassay Scientist will work part of a group of scientists that investigates mechanisms of immune modulation by novel pathogen-derived products.
Responsibilities:
1. Primary responsibility is to perform qualified/validated assays for the Quality Control group as required to support non-clinical and clinical programs. Prior experience in the following areas is required:
• ELISA assay development and application.
• Cell culture experience (primary and established cell lines).
• Working knowledge of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
• Working knowledge of biological R&D and QC operation.
2. Lead and/or participate in qualification and validation of bioassays.
3. Author SOPs, qualification/validation protocols and reports.
4. Act as an internal expert in bioassay development, provide scientifically and technically sound evaluation of assay performance, troubleshooting and failure investigations).
5. Ensure that the testing method used are in accordance with the appropriate regulatory requirements.
6. Review and approve data generated by laboratory personnel.
7. Demonstrates awareness and complies with accrediting agency and regulatory requirements related to their area of responsibility.
8. Meets department standards for productivity and quality. Participates in detecting and documenting occurrences that deviate from defined procedures.
9. Participates in departmental financial responsibilities through the appropriate use of supplies and materials and assists with inventory management.
10. Performs miscellaneous support duties as defined by the department.
Qualifications:
• MS/PhD in Biologicals Sciences (cell biology/immunology), combined with 3-5 years of relevant experience in bioassay development validation.
•Strong verbal and written communication skills that enhance teamwork.
•Ability to work independently, adhere to timelines, perform detailed work, multi-task, problem solve, and take direction and assimilate instructions quickly.
•Good organizational skills (i.e. organization of data for presentations, reports and regulatory documents such as INDs and BLAs) are also required.
Contact:
Please send resumes to jobs@biothera.com. No calls please.
Biothera is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Biothera complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Biothera in the U.S. |
| | Company | | Biothera | Job Code | | State or Province | | Minnesota | | |
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