Qureos Mentor

GC Therapeutics

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 Scientist / Senior Scientist &ndash; Cell Line Development
 
 
 
 
 
 
 
 Company Overview
 
 
 
 GC Therapeutics is the first genome-wide cell landscape exploration company using an integrated synthetic biology and AI-driven platform for cell programming. Its patent-pending and proprietary pluripotent stem cell di&fflig;erentiation technology platform TFome&trade; was developed in Professor George Church&rsquo;s lab, a pioneerin synthetic biology,and allows for the development of unique cell therapies with significantly streamlined manufacturing, improved cell quality, efficiency, and speed. GC Therapeutics is basedin Cambridge, MA. For additional information, please visitwww.gc-tx.com.
 
 
 
 
 
 
 Job Purpose
 
 
 
 GC Therapeutics is seeking a highly motivated Scientist or Senior Scientist to join our Cell Line Development (CLD) team. This role focuses on iPSC scale-up and differentiation from benchtop to production-scale bioreactors. The ideal candidate will engineer novel cell therapy products derived from human induced pluripotent stem cells (iPSCs) for regenerative and cell-based therapies and will contribute to the development of cell line candidates for early-phase clinical trials as part of a team developing iPSC derived cellular products and related quality control assays.
 
 
 
 
 
 
 Duties and Responsibilities
 
 
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 Culture iPSC lines including maintenance and analysis (e.g. cell culture, preparation of media, passaging, cryopreservation)
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 Perform cell engineering on iPSCs to generate products for cell therapies.
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 Design and execute experiments to optimize cell engineering processes for iPSCs and iPSC-derived cells .
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 Perform, analyze and interpret experimental data, ensuring comprehensive documentation of methodologies and outcomes.
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 Maintain a detailed laboratory journal, summarize results, and create presentations for meetings
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 Troubleshoot iPSC cell line engineering challenges, improving process robustness for GMP readiness.
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 Implement process changes for GMP compliance and support technology transfer to process development team.
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 Contribute to the development of product characterization assays (e.g., identity, purity, potency, mechanism of action and functional assays).
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 Draft and review batch records, SOPs and regulatory support documents for cell line engineering processes.
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 Maintain accurate and complete records, ensuring compliance with documentation management systems.
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 Collaborate with a multidisciplinary team including Analytical Development, Quality Assurance, Manufacturing, Operations, R&amp;D, etc.
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 Qualifications
 
 
 
 
 
 Essential Qualifications:
 
 
 
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 Advanced degree in cell biology, biochemical or biomedical engineering, cell therapy, or a related field with 2+ years of industry experience.
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 Strong expertise in iPSC culture and maintenance, cell engineering, characterization of engineered cells, and cloning
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 Hands-on experience with various cell type differentiation, characterization and experimental in-process and endpoint analysis including flow cytometry, ELISA and microscopy
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 Significant experience with molecular biology tools for integration site and off-target analysis.
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 Analyze differentiated cell products and establish QC metrics.
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 Optimize, refine and scale differentiation protocols for candidate cell therapeutic products.
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 Experience with documentation management systems
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 Experience with working in the Controlled Non-classified Space.
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 Knowledge of iPSC 2D and 3D cultures.
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 Proficiency in quality management system and data analysis tools.
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 Strong problem-solving, analytical, and documentation skills.
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 Ability to work independently and collaboratively in a cross-functional team.
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 Willingness to work outside normal hours including weekends to support lab activities as needed.
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 Additional Preferred Qualifications:
 
 
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 Experience with operations in GMP facilities and GMP guidelines.
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 Experience in scale-up, process development using 3D culture, organoids and bioreactor systems.
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 Proven track record and strong publications in stem cell or developmental biology.
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 Knowledge of FlowJo, next generation sequencing (NGS), bioinformatics (R, Python).
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 Expertise in genome integrity assessment and off-target characterization.
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 Familiarity with automation, high throughput (HTP) imaging and cell cloning.
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 Familiarity with relevant guidelines from the FDA, EMA and ICH.
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 Experimental Techniques:
 
 
 
 
 Cellular Biology:
 
 
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 Design and execute synthetic biology-based differentiation of iPSCs.
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 Optimize, and scale iPSC derived differentiation for therapeutic cell products.
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 Perform assays including Flow Cytometry, ELISA, ICC, cell-based assays and microscopy.
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 Conduct DOE studies to optimize parameters affecting engineered iPSC growth and differentiation.
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 Molecular Biology:
 
 
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 Perform PCR, qPCR and ddPCR for cell characterization.
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 Characterize target cells using next-generation sequencing (e.g., library preparation for bulk and single cell RNA-seq)
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 Conduct genome integrity assessment and off-target characterization
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 General Laboratory:
 
 
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 Lead experimental design, data analysis, and presentation of results to team members.
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 Maintain detailed and well-organized records of all experimental activities.
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 Provide scientific and technical guidance to junior staff or contract manufacturing organizations (CMOs).
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 Ensure compliance with GDP, GMP, safety regulations, and company policies.
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 Stay current on scientific advancements and contribute to innovative research.
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 Pay Range
 
 
 
 $120,000 - $145,000
 
 
 (This range reflects the base salary only and does not include additional compensation such as annual bonus and equity awards, which are part of the total compensation package.)
 
 
 
 
 
 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
 
 
 
 
 
 At GC Therapeutics, our generous competitive benefits package also include generous PTO, paid holidays, Medical, Dental, Vision, 401(k), Life and Disability Insurance and transportation subsidy.
 
 
 
 
 
 
 Equal Opportunity Workplace:
 
 GC Therapeutics is an equal opportunity employer. We provide equal employment opportunities to all applicants for employment and existing employees without regard to ancestry, national origin, place of birth, race, color, gender, sexual orientation, marital status, pregnancy, religion, age, disability, gender identity, results of genetic testing, service in the military or otherwise to the full extent of all federal, state and local laws. GC Therapeutics&rsquo; equal employment opportunity policy applies to all terms and conditions of recruiting, hiring, placement, training, compensation, transfer, leave of absence, employment, promotion, layoff and termination of employment.
 
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Scientist/Senior Scientist - Cell Line Development

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GC Therapeutics

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Scientist/Senior Scientist - Cell Line Development