Scientist/Senior Scientist, Potency Assays

Position Summary:

Orbital Therapeutics is seeking a motivated and skilled scientist to join the Analytical Development team. This candidate will collaborate with the research team, delivery team, process development, and other CMC groups to develop novel bioassays, including potency assays. The candidate will also conduct method transfer and qualification activities.

Responsibilities:

• Manage the development and pre-qualification work of multiple cell-based assays for RNA/LNP drug substance and drug product.
• Coordinate with other colleagues within analytical development and the research group to transfer the phase-appropriate methods to external testing labs for GMP release testing and stability program.
• Work as the subject matter expert to ensure potency assay(s) are implemented at external QC testing lab(s) with technical support including troubleshooting potential issues during the transfer and qualification process.
• Draft and review development reports, testing methods, and other SOPs, and assist in the preparation of CMC regulatory filings.
• Work with other SMEs to onboard new bioassays and improve existing assay performance.
• Work collaboratively and communicate data effectively through internal and external partners.

Qualifications:

• Ph.D. with 2+ years or B.S/M.S. with 6-8+ years of working experience such as CAR-T cell therapy and/or related area. Title and scope of role will be commensurate with experience.
• Hands-on experience with multiple immortalized and primary cell lines is required.
• Extensive experience in characterization of immune cells using flow cytometry and other functional assays is highly desired.
• Experience with biochemical assays such as ELISA, MSD, Western blot, qPCR, ddPCR, etc. is desired.
• Experience with assay transfer and qualification from development lab to external testing labs for early-stage program is desired.
• Strong problem-solving skills and proven ability to work independently and in a team in a startup environment is preferred.
• Detail-oriented in assay development and documentation in a regulatory environment is desired.