Senior Scientist, Bioassay Development/Validation
Description
Biothera is seeking a senior scientist to guide the development of existing bioassay for validation and use in a regulatory environment. Key responsibilities and tasks include:
- Assist in troubleshooting/optimizing existing bioassays for existing projects as part of ongoing commitments
- Drive qualification activities for the bioassays
- Lead and/or participate in validation of bioassays
- Author SOPs, qualification/validation protocols and reports
- Assay leader responsibilities – act as an internal expert in bioassay development, provide scientifically and technically sound evaluation of assay performance, troubleshooting and failure investigations)
- Ensure that the testing method used are in accordance with the appropriate regulatory requirements
- Review and approve data generated by laboratory personnel
- Train staff in new technologies if applicable
Qualifications
- Requires a MS/PhD degree in biological sciences (cell biology/immunology) combined with 3-5 years of relevant experience in bioassay development/validation
- Demonstrated experience in assay development and validation in compliance with regulation standards/guidelines
- Working knowledge of biological R&D and QC operation
- Hands-on technical skills in various biological systems combined with working knowledge of statistics used to support method development
- Strong literature review abilities and aptitude to develop methods based on information gained from scientific literature
- Excellent writing, interpersonal, and communication skills
Send resume to jobs@biothera.com. No calls please.