Manager, Formulation (Stability)
Location: South San Francisco, CA
Position type: Full-time
Five Prime Therapeutics, Inc. (NASDAQ: FPRX) is a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics to alter the tumor microenvironment to enhance tumor cell killing. Our company has a growing portfolio of product candidates and currently has three protein therapeutics in clinical development.
- Cabiralizumab (FPA008) – a monoclonal antibody targeting CSF1R in a Phase 1/2 clinical trial in pigmented villonodular synovitis (PVNS) and in a Phase 1a/1b clinical trial in multiple cancers in combination with Bristol-Myers Squibb Company’s PD-1 immune checkpoint inhibitor, Opdivo® (nivolumab)
- FPA144 – a monoclonal antibody targeting FGFR2b in a Phase 1 clinical trial in FGFR2b over-expressing gastric cancer
- FP-1039 – an FGF ligand trap in a Phase 1b clinical trial in mesothelioma
Five Prime has a differentiated target discovery platform and library that we use to rapidly interrogate the entire extracellular proteome in medically relevant in vitro and in vivo models to discover novel targets and drug leads. Our technology has been validated by our growing pipeline and through multiple collaborations with pharmaceutical companies, including Bristol-Myers Squibb, UCB Pharma, S.A. and GlaxoSmithKline across a range of therapeutic areas. 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 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
- Participate other formulation development activities in lab to support projects 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
Please upload your cover letter & resume.