Analytical Development Scientist (Senior Scientist)

CiRC Biosciences, a pioneering cell therapy company, is seeking a talented and experienced analytical development scientist to contribute to development of innovative therapies for various therapeutic indications. The successful candidate will serve as a key member of the development team, strengthening our cell therapy platform by improving our capabilities to characterize and understand our products. This position requires a hands-on individual with a strong understanding of analytical technologies and strategies. The successful candidate will have experience in a wide range of methods used for cell characterization. Specific expertise in cell therapy development or characterization of differentiated cells derived from human stem cells is a plus. The analytical development scientist will work in close collaboration with colleagues in R&D, process development, and quality, and will play a key role in transferring methods to a contract development and manufacturing organization (CDMO) for implementation in GMP manufacturing.

As a member of CiRC's analytical development team, you will work under the direction of the Sr Director, Cellular Engineering to develop novel methods to characterize cell therapy candidates and/or be transferred for testing and release GMP product. This is an exciting interdisciplinary role in a dynamic, rapidly advancing company that will contribute directly to the progression of new therapies.

Responsibilities

• Collaborate with R&D and process development to develop analytical testing strategies for in-process, lot release, or product characterization.
• Serve as a subject matter expert on analytical methods for characterization of cell therapy candidates.
• Develop novel methods and improve existing methods for analysis and characterization of cell therapy candidates.
• Design, execute and analyze experiments to optimize and qualify developed methods.
• Assist R&D and process development with analysis and characterization of cell cultures using a wide range of molecular and cell biology assays (e.g. ELISA, q-PCR, flow cytometry, immunoassays, plate-based assays, and high content imaging).
• Train personnel on methods and help to improve methods as necessary.
• Work with CDMO to transfer developed methods and provide technical support for cGMP testing of pre-clinical and clinical study materials. Review test records, OOS, deviations, change control, or investigations related to the implemented methods.
• Participate or lead cross functional teams or projects
• Assist in the preparation of relevant CMC sections of regulatory submissions
• Draft and review SOP, experimental plans, protocols, and technical reports.

Qualifications

• Degree in biological engineering, life sciences, or related field with experience in analytical development. PhD and 3+ years of relevant experience, Master's degree and 5+ years of relevant experience, or bachelor's degree and 8+ years of relevant experience. Prior experience in the biotech or pharmaceutical industry strongly preferred.
• Strong understanding and significant experience with cell characterization technologies, including high-content imaging and flow cytometry.
• Significant experience in common cell and molecular biology techniques (e.g., qPCR, ELISA, flow cytometry, cell-based assays).
• Strong understanding of assay development and validation and statistical methods. Familiarity with typical statistical software packages (e.g., JMP) a plus.
• Prior experience with method qualifications, verifications, and validations preferred.
• Experience authoring of CMC sections of regulatory submissions a plus.
• Self-motivated with good problem-solving skills and an ability to learn new skills.
• An ability to multi-task and prioritize assignments and to work effectively both independently and in a collaborative team environment.