Scientist/Senior Scientist, Analytical Development (Contract)

Position Summary

Orbital Therapeutics is seeking a motivated and skilled scientist to join the Analytical Development team. The successful candidate must possess extensive scientific knowledge and hands-on experience in cell biology/immunology and/or RNA therapeutics. The 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 research group to transfer the phase-appropriate methods to external testing labs for GMP release testing and stability program.
• Work as 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, 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 communicates data effectively through internal and external partners.
• The role is a lab-based contract position.

Qualifications:

• PhD or M.S. in cell biology, molecular biology, biochemistry or related discipline.
• Must have 2+ years of working experience in CAR-T cell therapy and/or related area.
• 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.
• Hands-on experience on Flow Cytometry is required.
• Experience with biochemical assays such as ELISA, Western blot, qPCR, 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.
• Demonstrated track record of consistently meeting deadlines in a dynamic, fast-paced environment.
• Detail-oriented in assay development and documentation in a regulatory environment is desired.