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.
We are currently seeking a highly motivated and innovative Ph. D level scientist to join our Process Development (PD) group. The primary responsibilities of the scientist include:
- In collaboration with team members, design and execute overall 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
- Provide guidance and supervision to junior research associates in formulation development activities
- Other assignment as needed
- Representing pharmacology functions on multiple immuno-oncology project teams and to senior management.
- Selection, management and oversight of mouse tumor models to support preclinical and clinical programs.
- Writing and authorizing study protocols and reports.
- Authorizing appropriate sections of regulatory documents (INDs, CTA, BLAs)
- Management of PhD and associate-level staff to execute department and corporate goals.
- Ph. D in Biochemistry, Biochemical Engineering, Pharmaceutics Sciences, or related fields with a minimum of 2 years of industry experience in biologic formulation development
- Must have in-depth understanding of the biophysical and biochemical degradation pathways for protein therapeutics in liquid formulation.
- Must have 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, cIEF, 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 required
- Familiar with selection of container/closure systems including prefilled syringes is required. Experience on extractables/leachables assessment is a plus.
- Direct experience on high concentration protein formulation and lyophilized formulation is highly preferred.
- Experience of GMP fill-finish of protein therapeutics is highly desirable
- Must have excellent scientific writing, communication, presentation, documentation, and organization skills
- Must be able to exercise critical judgment and make decision independently
Please upload your cover letter and resume