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 Sr. Research Specialist or Scientist I to join our Analytical Development group. This position reports to Scientist III, Analytical Development.
- Design and conduct ELISA and cell-based potency assay development and qualification
- Develop and test ELISA assays for in-process impurity analysis
- Troubleshoot and optimize assay performance
- Maintain detailed records of laboratory notebook
- Perform timely data trending and statistical analysis to evaluate assay performance
- Write and review technical reports and protocols
- Provide analytical testing support to process development and formulation development
- Monitor and qualify critical reagents and Reference Standard
- B.S. with 10+ years or M.S. with 8+ years or Ph.D. with 1+ years of industry experience in biochemistry, cell biology, molecular biology, immunology, analytical chemistry or related discipline
- Must have extensive technical expertise in either immunoassay (such as binding ELISA, competitive ELISA, SPR, MSD, DELFIA, etc.) and cell-based bioassay (such as ADCC, CDC, luciferase reporter assay, etc.) development and qualification
- Experience in qPCR based residual DNA assay development is highly desired
- Experience in host cell protein (HCP) and residual Protein A impurity assay is a plus
- Working knowledge of IHC guidelines on analytical method validation
- Familiar with GLP, GMP and FDA regulatory requirement is highly desired
- Familiar with data analysis and statistical analysis software, such as MS Excel, SoftMax, PLA, and JMP is preferred
- Excellent written and interpersonal communication skills to promote dialogue and influence others to reach solution
- Excellent organizational skills and detail-oriented at both the bench top and desktop. This includes the ability to manage work plans and timelines efficiently and independently manage competing priorities
- Ability to lead and work collaboratively with other team members in a positive and collaborative manner.
- Analytical and excellent problem-solving skills