Scientist l, Formulation

Location: South San Francisco, CA
Position type: Full-time, Exempt

Five Prime Therapeutics, Inc. (NASDAQ: FPRX) is a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics to alter the tumor microenvironment to enhance tumor cell killing. Our company has a growing portfolio of product candidates and currently has three protein therapeutics in clinical development. 

  • Cabiralizumab (FPA008) – a monoclonal antibody targeting CSF1R in a Phase 1/2 clinical trial in pigmented villonodular synovitis (PVNS) and in a Phase 1a/1b clinical trial in multiple cancers in combination with Bristol-Myers Squibb Company’s PD-1 immune checkpoint inhibitor, Opdivo® (nivolumab)
  • FPA144 – a monoclonal antibody targeting FGFR2b in a Phase 1 clinical trial in FGFR2b over-expressing gastric cancer
  • FP-1039 – an FGF ligand trap in a Phase 1b clinical trial in mesothelioma

Five Prime has a differentiated target discovery platform and library that we use to rapidly interrogate the entire extracellular proteome in medically relevant in vitro and in vivo models to discover novel targets and drug leads.  Our technology has been validated by our growing pipeline and through multiple collaborations with pharmaceutical companies, including Bristol-Myers Squibb, UCB Pharma, S.A. and GlaxoSmithKline across a range of therapeutic areas.  FivePrime is committed to innovation and outstanding science, values that are reflected in our people and our products. Discover more about FivePrime at www.fiveprime.com.

Position:

We are currently seeking a highly motivated and innovative scientist to join our Formulation Development (FD) group. The primary responsibilities of the scientist include:

  • In collaboration with team members, design and execute formulation development strategies for Five Prime’s therapeutic proteins to support toxicology and various clinical studies and commercial launch
  • Carry out lab experiments to generate study results to support the formulation development of the programs. These include design of study protocols, set up of the formulation screening/stability studies, manage the development stability programs and generate study reports
  • Collaborate with colleagues in Analytical Development to define and apply analytical methods for the characterization and stability testing of the protein therapeutics. Maintain the lab instruments in good working conditions
  • Participate in the interaction with CMO to support the fill-finish of GMP drug product for clinical supply. Prepare formulation report and technology transfer reports, participate in process transfer to CMOs for fill-finish of drug product, review manufacture batch records, and author documents for regulatory submissions
  • Interact and coordinate with Analytical Development, Clinical Supply Chain, Clinical Development, and Project Leaders in defining product presentation, dosing requirements and product shelf life
  • Stay current on state-of-the-art scientific knowledge and practice in biological drug product development. Innovatively integrate new technologies into the work stream within the company
  • Other assignment as needed

Qualifications:

  • Ph. D in Biochemistry, Biochemical Engineering, Pharmaceutics Sciences, or related fields with 0-2 years of industry experience in biologic formulation development
  • Good understanding of the biophysical and biochemical degradation pathways for protein therapeutics in liquid formulation
  • Hands-on experience in formulation development of therapeutic proteins. Prior experience with monoclonal antibodies or Fc-fusion proteins is a plus
  • Experience in common practices and procedures such as aseptic sample handling, stability program and stability pull, analytical method development and testing are required. Experience with SE-HPLC, iCE, IEX-HPLC, CE-SDS, DSC, light scattering, and HIAC particle counting are required
  • Good understanding of FDA and ICH guidelines associated with drug product development and drug substance and drug product stability assessment are plus  
  • Familiar with selection of container/closure systems including prefilled syringes is a plus
  • Self-motivated and capable of demonstrating technical competence and problem-solving skills  
  • Capable of working independently in a fast-paced, team-oriented environment, demonstrating multitasking capabilities
  • Must have excellent scientific writing, communication, presentation, documentation, and organization skills

Please upload your cover letter & resume.

Apply Here