Senior Scientist: iPSC Process Development & Scale-Up

GC Therapeutics; Cambridge (MA); On-site; USD 150,000 - 170,000; Full time

Benefits offered by this job

PTO

Health benefits

401(k)

Transportation subsidy

Life insurance

Disability insurance

Paid holidays

Job summary

GC Therapeutics in Cambridge, MA is seeking a Scientist or Senior Scientist for the Process Development team. This role focuses on iPSC scale-up and differentiation from benchtop to production-scale bioreactors, contributing to cGMP processes for early-phase clinical trials as part of a team developing iPSC-derived cellular products.

The ideal candidate has 5+ years in iPSC scale-up, differentiation and bioprocess development, with hands-on upstream and downstream capabilities, DOE/QbD

Qualifications

• 5+ years of industry experience in biochemical/biomedical engineering or related field.
• Deep expertise in iPSC scale-up, differentiation, and process development using 3D culture and bioreactor systems.
• Hands-on upstream and downstream bioprocessing experience (expansion, isolation, formulation, sterile filling, cryopreservation).
• Familiarity with FDA/EMA/ICH guidelines and statistical analysis tools.
• Strong problem-solving, analytical and documentation skills.
• Ability to work independently and collaboratively in a cross-functional team.

Responsibilities

• Design and execute process development experiments to optimize and troubleshoot upstream and downstream manufacturing processes for iPSCs and iPSC-derived cells.
• Scale iPSC expansion and differentiation from benchtop to bioreactor using stirred-tank bioreactor for GMP manufacturing.
• Conduct DOE/QbD studies to define CQAs and CPPs for scale-up and differentiation.
• Analyze and interpret data; meticulously document methodologies and outcomes.
• Troubleshoot bioprocessing challenges to improve GMP readiness and robustness.
• Implement GMP changes and support technology transfer to manufacturing.
• Contribute to product characterization assays (identity, purity, potency, mechanism of action).
• Draft and review technical reports, regulatory submissions (Module 3, IMPD) and batch records.

Skills

iPSC scale-up

Bioprocess development

GMP knowledge

Documentation

Cross-functional collaboration

Education

Advanced degree in biochemical/biomedical engineering or related

Tools

Stirred-tank bioreactor

Job description

GC Therapeutics in Cambridge, MA is seeking a Scientist or Senior Scientist for the Process Development team. This role focuses on iPSC scale-up and differentiation from benchtop to production-scale bioreactors, contributing to cGMP processes for early-phase clinical trials as part of a team developing iPSC-derived cellular products.

The ideal candidate has 5+ years in iPSC scale-up, differentiation and bioprocess development, with hands-on upstream and downstream capabilities, DOE/QbD