Five Prime Therapeutics, Inc. (NASDAQ: FPRX) is a publicly traded, clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics for patients with serious unmet medical needs. Five Prime has entered into strategic collaborations with leading global pharmaceutical companies and has promising product candidates in clinical and preclinical development.
We currently have three protein therapeutics in clinical trials:
- FPA008: a monoclonal antibody that inhibits the CSF-1 receptor and is being studied in multiple tumor settings and pigmented villonodular synovitis (PVNS)
- FPA144: a monoclonal antibody targeting FGFR2b for selected gastric cancers
- FP-1039: a FGF ligand trap for mesothelioma
On the strength of our unique discovery platform and capabilities, we have entered into strategic collaborations with leading global pharmaceutical companies. We currently have three active research collaborations with Bristol-Myers Squibb, GlaxoSmithKline and UCB Pharma, S.A.
Five Prime is committed to innovation and outstanding science to develop effective new drugs for the treatment of severe diseases. These values are reflected in our people and our products. We value our culture of openness, collaboration and productivity. Discover more about FivePrime at www.fiveprime.com.
FivePrime is seeking a highly motivated Scientist to join our Bioanalytical Development group. The Bioanalytical Development group is part of a matrixed organization that serves both research and discovery as well as later stage development programs. The group develops assays that serve internal research purposes and are subsequently transferred to GLP and/or clinical laboratories for validation and clinical sample testing.
This individual will focus on the development of bioanalytical methods supporting FivePrime’s pipeline of preclinical and clinical therapeutics antibodies. The Scientist will develop robust assays that measure the pharmacokinetics, and anti-drug antibodies of FivePrime’s preclinical and clinical candidates. The individual will also work closely with pharmacology and translational science departments to develop assays to measure predictive and pharmacodynamic biomarkers.
Responsibilities include but are not limited to:
- Develop tests for specific analytes and biomarkers to interrogate the biology of the pathways being targeted
- Develop, troubleshoot and transfer the following assay type:
- ELISA-based assays to detect monoclonal antibodies and other protein-based therapeutics in different matrices
- Meso-Scale Detection (MSD) technology to detect anti-drug antibodies
- Neutralizing Antibody Assays
- Knowledge and use of the Gyros Technology
- Keeping current and tracking changing trends in the regulatory requirements for bioanalysis as pertains to protein based therapeutics and monoclonal antibodies
- Contribute to appropriate sections of regulatory documents (INDs, CTA, BLAs)
- May represent the bioanalytical functions on project teams
- Ph.D. degree in biochemistry, chemistry, immunology or related science with a 2+ years of direct experience
- Proven experience working in a bioanalytical laboratory environment is essential
- Familiarity with GLP requirements is essential.
- First hand-experience in designing, developing and troubleshooting methods for pharmacokinetic and anti-drug antibodies that are suitable for use in GLP and clinical studies
- Track record of success as demonstrated by successful regulatory submissions (e.g., IND CTA, BLA), peer-reviewed publications and/or presentation at industry meetings is required
- Excellent written and interpersonal communication skills
- Ability to lead and work with others in a positive and collaborative manner
- Analytical and excellent problem-solving skills