Senior Specialist, Formulation (Stability)
- 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 and dedicated Stability Manager/Coordinator to join our Formulation group. This person will be responsible for the management of development and GMP stability programs for Five Prime’s therapeutic proteins in early and late stage development. The primary responsibilities include:
- Develop protocols for various stability studies including development stability study, IND stability study, long-term stability study, and in-use compatibility study etc. in collaboration with team members and external partners to support various programs in early and late stage development
- Serve as the contact person to interact with CMOs who conduct GMP stability studies for Five Prime’s drug substance and drug product in development. Coordinate the required activities to ensure the stability studies are executed according to schedules. Review and maintain collected stability data. Work closely with QA and Analytical Development for OOS/OOT investigation
- Perform statistical analysis to extrapolate and predict drug substance retest date and drug product shelf-life based on collected GMP stability data. Write interim and complete stability study report as appropriate
- Manage the internal long-term development stability program in collaboration with team members. Review, maintain and analyze the collected stability data. Write interim and complete stability study report as appropriate
- Stay current on state-of-the-art scientific knowledge and regulatory requirement from health authorities on stability of biological drug product development.
- Author formulation development and support stability sections of regulatory submissions
- Assist in the study set up and data collection for the internal stability programs as needed
- Participate formulation development activities in lab to support projects as needed
- BS or MS in Biochemistry, Biochemical Engineering, Pharmaceutics, or related fields.
- A minimum of 8+ years for BS degree or 6+ years for MS degree of industry experience for the Senior Stability Specialist.
- 5 years for BS degree or 3 years for MS degree of industry experience for the Stability Specialist in conducting stability studies for biological product development is required
- Must be familiar with FDA and ICH guidelines for stability study, stability testing of biological drug products, and evaluation of stability data
- Proficiency in statistical analysis of stability data using software packages is required
- Good understanding of the biophysical and biochemical degradation pathways for protein therapeutics in liquid formulation is highly desirable
- Prior hands-on experience in formulation development or analytical development using size exclusion HPLC, capillary isoelectric focusing (cIEF), ion exchange HPLC, capillary electrophoresis (CE-SDS), and sub-visible particulate matter analysis is a plus
- Must have excellent scientific writing, interpersonal communication and presentation skills
- Good planning and organization skills to perform work effectively
- Excellent problem solving skills and identify solutions accordingly
- Attention to Detail
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.
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