Senior Research Specialist - Process 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.
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.
We are currently seeking a highly motivated individual to contribute to the development of downstream protein purification processes for early to late-stage clinical manufacturing of mAbs and Fc-fusion proteins. You will be responsible for designing and performing bench and pilot scale experiments to produce material to support preclinical studies and work closely with scientists to ensure the successful technology transfer of well-designed unit manufacturing operations for clinical manufacturing.
The primary responsibilities include but not limited to:
- Independently develop scalable antibody purification processes
- Perform scale-up/down antibody purification experiments
- Small to medium-scale purification to support pre-clinical pharmacology studies
- Plan and execute process characterization studies for downstream operations
- Interact with Analytical Development and Cell Culture development groups within Manufacturing Sciences function
- Develop and implement new technologies for optimization and continuous improvement of current manufacturing process operations
- Lead technical discussions internally and with partnered contract manufacturing organizations
- Interpret data, present results of work, and draw conclusions on presented materials
- BS/MS in Chemical/Biochemical Engineering, Biochemistry or a related scientific discipline with 10+ years of relevant laboratory or manufacturing experience.
- Possess a solid understanding of all downstream manufacturing unit operations for biologics.
- Hands on experience in protein purification process development of downstream operations including normal flow filtration, affinity, ion exchange, hydrophobic interaction, and mixed-mode chromatography operations, tangential flow filtration, and virus inactivation/removal.
- Proficiency in performing protein analytical assays such as A280, SDS-PAGE, and SEC/IEX-HPLC.
- Proficiency in interpreting protein analytics and characterization data of macromolecules such as charge/glycan profile, sialic acid content, ELISA, HCP, etc.
- Extensive experience with Akta chromatography systems and proficient usage of Unicorn software is required
- Solid understanding and experience in process scale-up from bench scale to large scale.
- Knowledge of FDA and ICH guidelines for biologics manufacturing.
- Very strong organizational skills with the ability to maintain excellent records and documentation of process, procedures, and data are a must.
- Excellent analytical and problem-solving skills.
- Strong attention to detail and the ability to manage multiple assignments concurrently.
- Excellent verbal communication and interpersonal skills and ability to influence others.
- Prior experience with technology transfer of downstream processes to clinical manufacturing is preferred.
- Experience working with monoclonal antibodies and Fc-fusion proteins is strongly preferred.
- Experience with Design of Experiments and Quality by Design methodology is a plus.
- Familiarity with cGMP requirements and/or experience in a cGMP manufacturing setting.
- Some travel may be required.
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.
Five Prime acknowledges that providers may be a valuable resource for identifying and recruiting candidates for employment. However, we require that all recruiters engage directly with Five Prime’s Talent Acquisition Team and comply with Five Prime’s requirements prior to transmitting any resumes/CVs or introducing any candidates to Five Prime. Five Prime’s Talent Acquisition Team is the only function within the Company that can enter into contractual relationships with external recruiters and recruiting agencies. As such, all unsolicited resumes, CVs, anonymous profiles, or candidate information you may submit to employees of Five Prime will become property of Five Prime and Five Prime will have no obligation to pay you or anyone else for the use of such information, including any finder’s, placement, introduction or placement fee.