Scientist I, 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 assay development, characterization and qualification of potency assays including both binding assays and cell-based bioassays for early-stage and late-stage clinical programs. In addition, this scientist will perform impurity assays including residual host cell proteins, DNA and protein A to support process development efforts. This scientist will act as a technical resource for supporting process development, formulation development and product characterization. This scientist will also collaborate with the Research Group and evaluate the transfer of bioassays from the Research Group to the Analytical Development Group and further develop/optimize the assays as necessary. Further, this scientist will leverage their expertise to implement new technologies that can accelerate program timelines. The position will report to the Senior Scientist, Bioassay Development.
Responsibilities include but are not limited to:
- Develop and qualify bioassays following ICH guidelines to implement at CMO/CRO
- Draft protocols, execute studies, analyze data and draft technical reports
- Provide training to analysts and supervise assay transfer to CMO/CRO
- Participate in data review for technical correctness and regulatory compliance
- Participate in troubleshooting technical and procedural issues
- Comply with all pertinent regulatory agency requirements
- Review test methods, SOPs and specifications for biological assays
- Design and execute studies to increase the understanding of candidate molecules
- Work with cross-functional groups and external contract facilities to meet program timelines
- Evaluate new methodologies and test procedures and implement when needed
- Author analytical sections for regulatory submissions
- A PhD degree in biology, cell biology, biochemistry, molecular biology, immunology, or a related discipline with 0-2 years of laboratory experience in industry
- Must have hands-on experience in sterile cell culture techniques
- Excellent analytical and problem-solving skills
- Excellent written and interpersonal communication skills
- Highly motivated, flexible, and ability to multi-task
- Ability to influence and collaborate in a team environment
- Experience in a GLP environment highly desirable
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.