Altor BioScience Corporation is a leading biotech company in immune-therapeutics for cancer and infectious disease in south Florida. We are a participant of Cancer Breakthroughs 2020 Initiative. We also have a CRADA with NCI/NIH for development of Cancer therapeutics. As we are growing rapidly in order to initiate a phase 3 development and manufacturing program we are hiring an Associate Scientist/Scientist for our Assay Development Group.
The successful candidate will contribute to assay development at Altor Bioscience to develop, optimize and validate new and existing assays for product and clinical trial testing.
Summary of Responsibilities
• Timely execution of all aspects of assay development
• Support development, optimization and validation of new and existing assays for stability and release testing of clinical products in preparation for Phase 3/commercial manufacturing
• Support development, optimization and validation of new and existing assays of correlative markers in clinical trial patient samples
• Develop and implement bioanalytical assays for pharmacokinetic and immunogenicity for early and late phase product pipeline
• Troubleshoot and improve currently existing assays, as necessary
• Support assay development novel pipeline products in preparation for IND submissions
• Compile data to support/contribute to technical/development reports for regulatory submission
• Support technology transfer of assay methodology to contract manufacturing organizations
• Support troubleshoot technical issues and improve assays to increase robustness and efficiency
• Perform bench science with self-direction of work plans and experimental procedures
• Maintain scientific excellence and attention to detail
• Work collaboratively with project teams to advance Company goals
Scientist- Ph.D. in a Biotechnology related Scientific field
Associate Scientist- M.S. or B.S. in a Biotechnology related Scientific field.
Professional Work Experience Requirements
• 1+ years of Biopharma, Biopharmaceutical, Pharmaceutical or Biotechnology industry/academia experience
• Experience with flow cytometry, ELISA, mammalian cell culture, cell based assays, SDS-PAGE and western blot assays
• Prior preclinical or clinical bioanalytical immunoassay development experience is required. Experience with human matrices is preferred
• Ability to produce high quality and timely SOPs and reports
• Knowledge of GLPs, 21 CFR Part 11, FDA and EMA bioanalytical and immunogenicity guidance/guideline. Working knowledge in a GLP regulated environment is preferred.
• Fluency with MS Office suite (Word/Excel/PowerPoint)
• Excellent oral and written communication skills
• Strong interpersonal skills, a collaborator/ team player, open minded to the diverse opinions of others