Scientist–Bioanalytical Assay Development at Pionyr Immunotherapeutics
South San Francisco, CA, US
Pionyr Immunotherapeutics is a growing South San Francisco-based immuno-oncology company focused on novel approaches to generate anti-tumor immunity. Pionyr is looking for a highly motivated and dedicated candidate for a full-time Scientist position in our Preclinical Sciencesgroup. The candidate will play an integral role in advancing our therapeutic candidates into the clinic and supportingtarget discovery efforts. The ideal candidate will have extensive experience in bioanalytical method validation and bioanalysis in regulated settings. He (or she)will be responsible for establishing and monitoring clinical enabling bioassays conducted both internally and at CROs, including pharmacokinetics (PK),immunogenicity (ADA), biomarker, and neutralizing antibody assays (NAb). This position will involve manual laboratory work using various assay platforms, and management of outsourcing efforts to allow timely bioanalytical support for research and development activities.
Specific Responsibilities Include (but not limited to):
- Develop fit-for-purpose PK, PD, ADA, and NAb assays that meet the needs of the program.
- Concisely summarize bioanalytical results and write technical reports to achieve required milestones and support regulatory filings.
- Report and interpret laboratory results to the project team and, where applicable, senior management.
- Manage method transfer and outsourcing activities.
- Review assay protocolsand study reports under regulatory guidance.
- This individual is expected to work independently and collaboratively, handle multiple projects, and deliver timely resultsin a fast-paced environment.
Pionyr Immunotherapeutics, Inc. offers competitive salaries, participation in company stock-incentive plans and benefits packages, in addition to a dynamic academic-driven scienceand collaborative environment.
- Ph.D. with 2+ years,M.S. with 10+ years, or B.S. with 12+ years of relevant biotechnology industry experience.
- Thorough understanding of the FDA’s and EMA’s regulatory guidance related to bioanalytical assays.
- Experience in developing large-molecule (protein and antibody) bioanalytical assays (PK, ADA and Nab) in a regulated environment.
- Extensive assay development experience on MSD, Luminex and/or Gyros platforms.
- Previous experience liaising and managing a CRO is desirable.
- Strong communication skills including verbal andwritten rports and updates as well as theability to contribute to multiple projects in a fast-paced environment.