Scientist III, Bioassay Development
- 111 Oyster Point Blvd, South San Francisco, CA 94080, USA
Five Prime Therapeutics, Inc. (NASDAQ: FPRX) is a publicly traded, clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics to improve the lives of patients with serious diseases. We have an industry-leading and differentiated drug discovery platform. Our comprehensive proprietary libraries of the extracellular proteome, differentiated screening capabilities and protein therapeutic generation and engineering capabilities comprise a unique and powerful IND engine that will continue to generate important development programs. This uniquely positions us to discover novel pathways and targets in immuno-oncology. Our success with our drug discovery platform has led to a pipeline that is on track to more than double to five development programs in clinical trials across multiple indications in 2018. We also have several undisclosed research programs at different points of the target validation and molecule generation phases that have the potential to yield our next wave of development-stage therapeutic biologics. And we continue to fuel this process at the earliest stages with new screens planned this year.
Five Prime is committed to innovation and outstanding science to develop effective new drugs for the treatment of severe diseases. We value our culture of openness, collaboration and productivity. The company is in a strong financial position and has an effective executive team and Board of Directors. Discover more about FivePrime at www.fiveprime.com.
We are currently seeking a highly motivated individual to join our Analytical Development group. This position will be responsible for leading the development of potency (both binding and bioassay) assays for a number of pre-clinical and clinical programs. Additionally, the successful candidate will also lead the development of process impurity assays. The scientist will also leverage their expertise to implement new technologies that can accelerate program timelines. The position reports to the Director in Analytical Development.
Responsibilities include but are not limited to:
- Develop and qualify assays to implement at GMP QC groups following ICH guidelines
- Develop bioassays in line with USP requirements, including bioequivalence approaches
- Design and execute studies to increase the understanding of candidate molecules
- Work with Process Development functional groups to ensure program timelines are kept
- Author analytical sections for regulatory submissions and prepare reports for analytical characterization and technical transfer
- Manage staff to develop a number of different potency and process impurity assays
- Provide expert guidance to research groups on assay design
- Other projects when assigned
- A Ph.D. degree in biology, biochemistry, chemical engineering, or a related discipline with 5-8 years of laboratory research experience in industry
- Understanding of FDA and ICH guidelines as well as GLP/GMP principles associated with analytical development
- Experience transferring assays to contract laboratories is a plus
- Extensive experience developing bioassays and biophysical potency assays is required
- Experience developing process impurity assays such as HCP, DNA, and ProA methods is preferred
- Managing and leading a team while also providing analytical guidance within Process Development
- Highly motivated, flexible, and multi-tasks
- Excellent written and interpersonal communication; ability to influence and collaborate in a team environment
- Analytical and excellent problem-solving skills
At FivePrime, we believe a diverse workforce drives our success as a company. We are always working to create an environment where different backgrounds and viewpoints are valued and celebrated.
FivePrime is an equal opportunity employer. FivePrime makes employment decisions, including in recruitment and selection, without consideration of race, color, national origin, religion, sex, gender, gender identity or expression, sexual orientation, age, veteran status or disability.Please call or reply with any comments.
All your information will be kept confidential according to EEO guidelines.