Temporary Research Associate II-III Analytical & Formulation Development
- South San Francisco, CA, USA
Five Prime Therapeutics, Inc. develops innovative protein therapeutics to improve the lives of patients with cancer. The company focuses on developing immune modulators and precision therapies for solid tumor cancers paired with companion diagnostics to identify patients who are most likely to benefit from treatment with Five Prime’s product candidates. The company’s product candidates have innovative mechanisms of action and address patient populations in need of better therapies. Five Prime has entered into strategic collaborations with leading global pharmaceutical companies and has promising product candidates in clinical and preclinical development. For more information, please visit www.fiveprime.com.
We are currently seeking a highly motivated individual to join our Analytical and Formulation Development group. This position will be responsible for the supporting a wide range of analytical assays and formulation development studies for pre-clinical and clinical programs at contract research organizations (CROs) or contract manufacturing organizations (CMOs). The motivated research associate will also contribute to designing and outsourcing protein characterization studies and be a key contributor to the development of the preclinical and clinical programs.
Responsibilities include but are not limited to:
- Support analytical method development, optimization, troubleshooting, and qualification to implement at GMP QC groups for lot release and stability studies.
- Collaborate with QC groups at CMOs sites to manage assay transfer, design of qualification protocols, assay maintenance, establishment of assay controls, manage timely sample analysis, and review of analytical results.
- Collaborate with formulation development CROs to design and draft formulation development study protocols, monitor study results, review study reports and troubleshoot unexpected results.
- Support outsourcing product characterization studies for preclinical programs and collaborate and manage CROs performing studies.
- Author test methods, study protocols, and method development reports for preclinical programs.
- Work within a team environment to gain greater understanding of the therapeutic programs.
- A BS or MS degree in biochemistry, chemistry, chemical engineering, or a related discipline with 3-8 years of laboratory research experience in industry
- A solid understanding of protein chemistry related to biological drug development.
- Extensive experience with a wide variety of analytical platforms including H/UPLC, CE, are ELISA is required
- Experience developing protein and antibody assays such as SEC, CE-SDS, icIEF, peptide mapping, and glycan analysis is highly preferred
- Experience with bioassays, qPCR and mass spectrometry is preferred
· Highly motivated, flexible, and multi-tasks
· Excellent written and interpersonal communication; ability to influence and collaborate in a team environment and CROs and CMOs
· Analytical and excellent problem-solving skills
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.
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.