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Research and Development Scientist

2 months ago

Cambridge, Massachusetts, United States GC Therapeutics Full time
Job Summary

We are seeking a highly motivated and talented Senior Research Scientist to support the qualification and validation of assays for the testing, characterization, and release of novel Pluripotent Stem Cell (PSC) derived products.

Key Responsibilities
  • Design, develop, and validate assays for testing the safety and efficacy of stem cell-derived drug substances, products, and critical starting material.
  • Analyze data and contribute to complex technical reports and team meetings.
  • Contribute to and author module 3 documents, including analytical procedure development and validation of analytical procedures necessary for IND submissions.
  • Develop procedures and protocols for the genetic, transcriptomic, proteomic, and functional characterization of pluripotent stem cells and their derivatives.
  • Qualify and validate product-specific assays to determine identity, purity, and potency of PSC-derived products, including various cell-based assays, flow cytometry, immunohistochemistry, ELISA, and ddPCR.
  • Prepare complex technical reports, including SOPs, test methods, and method development reports.
  • Lead the transfer of assays to the quality control (QC) team and external contract manufacturing organizations as needed.
  • Contribute to team and company presentations.
General Laboratory Roles
  • Responsible for experimental design, data generation, analysis, and communication of results to supervisor and team members.
  • Maintain well-organized and up-to-date records of all research activities, including writing detailed protocols, technical reports, and developing appropriate documentation for processes.
  • Provide scientific and technical supervision to junior staff or contract manufacturing organizations for defined projects.
  • Maintain a detailed laboratory journal, summarize results, and create presentations for internal group meetings.
  • Exemplify scientific curiosity and deep expertise with relevant literature and cutting-edge technologies to advance research directions.
  • Work with other members of the research team and process development team to accomplish company goals.
  • Follow all safe laboratory practices and company policies.
Experimental Techniques
  • Analyze differentiated cell products and establish QC assays.
  • Qualify and validate cell-based biological assays and other quantitative assays, including flow cytometry and immunohistochemistry.
Qualifications
  • PhD with 2 years of molecular and cellular assay development in the biotech industry, or MS in Biology, Molecular Biology, or similar with 5+ years of related experience, or BS with 10+ years of related experience.
  • Experience in the development and validation of cell-based assays and flow cytometry assays to assess major cell populations detected in several differentiated PSC-derived products.
  • Expertise in designing and executing experiments to determine assay performance, including specificity, accuracy, precision, linearity, range, reproducibility, and robustness.
  • Experience in developing assays that use methods such as flow cytometry, qPCR, and ddPCR, immunoassays, and/or next-generation sequencing.
  • Experience writing technical documents for assays, including SOPs, test methods, and method development reports.
  • Demonstrated ability to work in a dynamic environment as a team player and committed to completing projects within timelines.
  • Experience in writing technical documents for assays, including SOPs, test methods, and IND-ready documentation for submission to regulatory authorities.
  • Proficient in analysis, presentation, and documentation of scientific data, as well as preparation of scientific reports.
  • Effective communicator with excellent interpersonal skills.
  • Strong project management and organizational skills, with the ability to prioritize and multitask.
Additional Preferred Qualifications
  • Desired skills include stem cell culture experience and computational biology.
  • Knowledge of PSC manufacturing principles, risk assessments, Chemistry, Manufacturing, and Controls (CMC) principles.
  • Experience with PSC, with practical familiarity with stem cell differentiation protocols.
  • Knowledge of R, Python, Bionano instrument, and FlowJo.
  • Familiarity with techniques used to measure genome integrity and off-target characterization.
  • Familiarity with automation, high-throughput (HTP) imaging, and cell cloning.