Scientist / Senior Scientist - Process Development

Scientist/Senior Scientist – Process 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 differentiation technology platform TFome™ was developed in Professor George Church’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 Process Development (PD) team. This role focuses on iPSC scale-up and differentiation from benchtop to production-scale bioreactors. The ideal candidate will have deep expertise in induced pluripotent stem cell (iPSC) process development, scale-up and differentiation and will contribute to the development of cGMP processes for early-phase clinical trials as part of a team developing iPSC derived cellular products and related quality control assays.

Duties and Responsibilities

• Design and execute process development experiments to optimize and troubleshoot upstream and downstream manufacturing processes for iPSCs and iPSC-derived cells including culture, expansion, differentiation, isolation, formulation, sterile filling, and cryopreservation.
• Scale iPSC expansion and iPSC differentiation processes from benchtop to bioreactor production for GMP manufacturing.
• Execute process optimization studies using QbD principles (e.g., FMEA, DOE) to define Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs), ranges and criteria for iPSC scale-up and differentiation.
• Analyze and interpret experimental data, ensuring comprehensive documentation of methodologies and outcomes.
• Troubleshoot upstream and downstream iPSC bioprocessing challenges, improving process robustness for GMP readiness.
• Implement process changes for GMP compliance and support technology transfer to manufacturing.
• Contribute to the development of product characterization assays (e.g., identity, purity, potency, mechanism of action and functional assays).
• Draft and review technical reports, regulatory support documents and CMC regulatory submissions (e.g., Module 3, IMPD).
• Author batch records for technology transfer and provide on-the-floor support for clinical-grade cell manufacturing.
• Maintain accurate and complete records, ensuring compliance with documentation management systems.
• Collaborate with a multidisciplinary team including Analytical Development, Quality Assurance, Manufacturing, Operations, R&D, etc.

Qualifications

Essential Qualifications:

• Advanced degree in biochemical or biomedical engineering, cell therapy, or a related field with 5 years of industry experience.
• Strong expertise in iPSC scale-up, differentiation, and process development using 3D culture and bioreactor systems.
• Hands-on experience with upstream and downstream bioprocessing (e.g., cell expansion, transfection, isolation, formulation, sterile filling, cryopreservation, etc.).
• Experience with documentation management systems.
• Familiarity with relevant guidelines from the FDA, EMA and ICH.
• Proficiency in statistical analysis tools (e.g., JMP, SigmaPlot, Stata).
• Strong problem-solving, analytical, and documentation skills.
• Ability to work independently and collaboratively in a cross- functional team.
• Willingness to work outside normal hours including weekends to support lab activities as needed.

Additional Preferred Qualifications:

• Experience in genome editing and characterization of engineered cells.
• Proven track record and strong publications in stem cell or developmental biology.
• Knowledge of next generation sequencing (NGS), bioinformatics (R, Python), Bionano instrument and FlowJo.
• Expertise in genome integrity assessment and off-target characterization.
• Familiarity with automation, high throughput (HTP) imaging and cell cloning.

Experimental Techniques:

Cellular Biology:

• Design and execute synthetic biology-based differentiation of iPSCs.
• Optimize, and scale iPSC derived differentiation for therapeutic cell products.
• Perform assays including flow cytometry, ELISA and microscopy.
• Conduct DOE studies to optimize parameters affecting engineered iPSC growth and differentiation.

Molecular Biology:

• Perform PCR, qPCR and ddPCR for cell characterization.
• Characterize target cells using next-generation sequencing (e.g., library preparation for bulk and single cell RNA-seq).
• Conduct genome integrity assessment and off-target characterization.

General Laboratory:

• Lead experimental design, data analysis, and presentation of results to team members.
• Maintain detailed and well-organized records of all experimental activities.
• Provide scientific and technical guidance to junior staff or contract manufacturing organizations (CMOs).
• Ensure compliance with GDP, GMP, safety regulations, and company policies.
• Stay current on scientific advancements and contribute to innovative research.

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’ 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.