Position: Senior Bioassay Scientist/Manager
A senior bioanalytical scientist/manager is required to guide the existing bioassays for qualification/validation and use in a regulatory environment. The Senior Bioassay Scientist will work part of a group of scientists that investigates mechanisms of immune modulation by novel pathogen-derived products in a small biotechnology research company.
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)
- DNA assays
- 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
- A MS/PhD in Biological Sciences (cell biology/immunology), combined with 3-5 years of relevant industry experience in bioassay development and validation.
- Good verbal and written communication skills and the ability to promote positive communications that enhance teamwork
- Able 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.
- Previous experience in managing a team of scientists is a plus.
Contact
Send resume to jobs@biothera.com. No calls please.