hESC Associate Scientist/Scientist
hace 4 días
Germantown
Job Description Overview Our client is a biotechnology company that uses a TM proprietary process to turn somatic cells into totipotent cells, and then to any cell or tissue, faster, more reliably, more efficiently, and with none of the challenges of alternative methods. Products developed using this TM process holds enormous potential to revolutionize cell and gene therapies, food and water testing, and regenerative medicine. These new products will open new markets and enable safer drugs, other products and consumables for humans and animals. Embryonic Stem Cell Associate Scientist/Scientist I/II Our client is seeking a highly skilled Associate Scientist/Scientist to contribute to our efforts in embryonic stem cell biology and early development processes. This role involves hands-on work with human pluripotent stem cells, development of differentiation protocols and stem cell-based solutions, and application of advanced analytical methods to study lineage specification and embryogenesis. The successful candidate will design, execute, and optimize experiments, interpret complex datasets, and collaborate closely with multidisciplinary teams to advance our scientific and translational objectives, deepen our understanding of embryonic stem cell development, facilitate next-generation therapeutic platforms, and help drive high-quality, reproducible science in a fast-paced, cross-functional environment. Education: • MSc/PhD in Stem Cell Biology, Developmental/Cell Biology, Embryology, Molecular/Cell Biology, Reproductive Biology, or related fields., • 3-6 years of relevant industry experience., • Prior experience in biotech, GMP, or regulated lab environments strongly preferred., • Demonstrated expertise in applied research, translational projects, process development, and a strong product‑oriented approach., • Certification as a stem cell professional (CSCP) is preferred but not a requirement. Responsibilities: • Expand and maintain human embryonic stem cells (hESCs) under feeder-free and feeder-based conditions, including media optimization and validation., • Develop 2D and 3D (organoid) cell cultures., • Ensure stable pluripotency, perform routine passaging, and prevent spontaneous differentiation., • Execute and optimize differentiation protocols into specific lineages (endoderm, mesoderm, ectoderm)., • Perform colony picking, clonal expansion, and establish new and stable hESC lines., • Scale up hESC cultures from research grade to clinical grade production (suspension, bioreactors, automation-ready systems)., • Apply knowledge of early embryo development (cleavage to blastocyst), germ layer formation, and lineage specification., • Characterize stem cells using flow cytometry for pluripotency and lineage markers. Potency assay development. Immunostaining assays. qPCR, and gene expression profiling. Protein assays (Western blotting and ELISA). Fluorescence or confocal microscopy and live-cell imaging. Single cell RNA-Seq and other omics platforms., • Assess genomic stability through karyotyping and related assays., • Analyze experimental data using appropriate software and statistical tools (e.g., FlowJo, ImageJ, GraphPad Prism, etc.)., • Design, express, and troubleshoot mRNA constructs, perform transfections for transient gene expression, optimize delivery methods for high efficiency, isolate clones, express and validate encoded proteins in hESCs., • Create and maintain master and working cell banks., • Conduct QC assays for viability, identity, sterility, and contamination control (e.g., bacteria, mycoplasma)., • Optional: Optimize culture system, differentiation protocols under defined conditions, and assay workflows., • Work within GLP/GMP guidelines for stem cell and their derived products when applicable., • Ensure compliance with ethical and regulatory requirements for hESC research., • Design, execute, and troubleshoot complex experiments independently., • Maintain accurate lab notebooks, documentation, and follow SOPs and quality systems., • Present data clearly in meetings, reports, and cross-functional reviews., • Lead independent research projects and contribute to scientific strategy., • Support white paper/manuscript preparations and conference presentations as needed. Technical expertise: • Experience with translational research or clinical trials involving embryonic stem cells and developmental embryology., • Proficient in the isolation and derivation of hESC lines, characterization using analytical and molecular assays, and karyotyping/genomic stability analysis., • Familiarity with key signaling pathways, including Wnt, BMP, FGF, TGF-b., • Knowledgeable in clonal isolation, screening, and validation; transfection and transduction methods; and cryopreservation, thawing, stability testing, and recovery of hESCs., • Strong understanding of ethical guidelines overseeing hESC research., • Familiarity with Institutional Review Board (IRB) processes and institutional compliance requirements., • Knowledge of national and international stem cell regulations (NIH and FDA guidelines) and regulatory expectations for clinical grade ESC/iPSC products (identity, purity, potency assays)., • Experienced contributing to IND-supporting studies and ethical compliance in human and animal research., • Understanding of FDA regulatory frameworks, CMC and batch records, and SOP development, optimization, and documentation., • Strong collaboration skills with various teams and clear, effective scientific communication, including data presentation and detailed reporting., • Demonstrated problem-solving ability and expertise in troubleshooting complex experimental workflows., • Experience mentoring junior scientists or technicians., • Exceptional attention to detail, essential for embryonic stem cell workflows., • Ability to present research outcomes and contribute to white papers/manuscripts., • Demonstrate project management capabilities and work within timelines and budgets., • Proficient in aseptic techniques and experienced working in BSL-2 environments., • Competence in experimental design and data analysis.