Five Prime Therapeutics, Inc. (NASDAQ: FPRX)
is a biotechnology company focused on discovering and developing transformative protein-based medicines for patients with serious unmet medical needs. The company has an emerging portfolio of innovative products for inflammation and cancer, and currently has 3 protein therapeutics in clinical testing covering 11 indications.
FivePrime also focuses on developing world-class companion diagnostic and biomarker strategies for the appropriate therapeutic settings. FivePrime’s discovery platforms can rapidly interrogate the entire extracellular proteome in medically relevant in vitro and in vivo models leading to novel targets and drug leads. Our technology has been validated by our growing pipeline and through multiple partnerships with pharmaceutical companies including GlaxoSmithKline, UCB, and Bristol-Myers Squibb across a range of therapeutic indications. FivePrime is committed to innovation and outstanding science, values that are reflected in our people and our products.
We are currently seeking a highly motivated and dedicated Stability Manager 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 use-time 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 stability sections of regulatory submissions
- Assist in the study set up and data collection for the internal stability programs as needed
- Other assignments as needed
- BS or MS in Biochemistry, Biochemical Engineering, Pharmaceutics, or related fields. A minimum of 8+ years for BS degree or 5+ years for MS degree of industry experience 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