Title: Analytical Scientist – Bioanalytical Assay Development
Cellics Therapeutics is seeking a self-motivated analytical scientist to join the analytical sciences team. This scientist is expected to have a solid scientific background and hands-on experience in bioanalytical assay and immunoassay method development to support our preclinical and clinical programs.
Essential Duties and Responsibilities:
- Develop, qualify, and validate biologics ELISA based/cell-based potency assays for drug candidate selection, process development, product release and stability, comparability, and technology transfer.
- Develop ELISA or LC-MS/MS based methods of bioanalysis to support nonclinical and clinical studies.
- Conduct analytical testing, collect analytical data, and collaborate with Quality Control (QC) and Process Development (PD) groups.
- Draft SOPs, methods, and reports, generate reference standards, establish sample and critical reagents tracking system.
- Draft assay qualification/validation protocols, assay qualification/validation reports, perform data QC.
- Draft technical documents and regulatory submissions.
- Other tasks as needed.
- Ph.D. or M.S. in Biology, Biochemistry, or related science discipline.
- 2+ years of experience for Ph.D. or 5+ years of experience for M.S. in bioanalytical assay development.
- Thorough knowledge of regulated bioanalysis in nonclinical development, along with the ability to translate those assays into clinical development.
- Hands-on experience with bioanalytical method development (e.g., cytotoxicity assays, flow cytometry/ELISA-based assays) and validation consistent with regulatory requirements.
- Hands-on experience with various analytical and bioanalytical techniques.
- Self-starter and team player.
If interested, please send your resume to email@example.com.