SlipstreamJobs tracks this role from the company's public career site. Apply directly on the employer's site.
Harton is seeking a Senior Scientist to lead biological process development for stem and stem-derived cell manufacturing. You will develop robust and reproducible iPSC expansion processes and refine the process architecture required to support automated stem and stem-derived cell manufacturing on Harton's novel bioprocessing platform.
You will work within a small multidisciplinary science and engineering team, taking ownership of the stem cell manufacturing program. Your immediate focus will include determining starting cell state, seeding and perfusion culture strategy, 3D culture matrix environment, analytical and QA/QC requirements, cell recovery and passage, and passage-to-passage reproducibility.
Key responsibilities include:
- Lead development and optimization of robust, reproducible iPSC expansion processes on Harton's automated 3D perfusion bioprocessing platform
- Design and execute systematic studies to define fundamental process architecture for iPSC expansion, including starting cell state, seeding strategy, perfusion culture conditions, cell density, spatial organization, 3D culture matrix environment, passage strategy, and recovery/harvest
- Establish appropriate input specifications, process parameters, acceptance criteria, and output measures for reproducible stem-cell expansion
- Develop, establish, and interpret analytical methods to characterize iPSC identity, pluripotency, viability, growth, differentiation state, and overall process performance using imaging, cytometry, molecular assays, and other techniques
- Establish robust approaches for cell-line handling, cryopreservation, recovery, banking, passage history, and long-term maintenance of cell quality
- Define biological and process requirements for Harton's instrumentation, automation, consumables, and software
- Work closely with external scientific collaborators and internal engineering teams to translate established protocols into reproducible automated workflows
- Support translation of established directed-differentiation workflows onto the platform, including stem-cell-derived cell types relevant to regenerative medicine and advanced cell manufacturing
- Help establish the scientific basis for new workflows, applications, and cell products enabled by Harton's platform
- Build experimental practices and documentation that support reproducibility, process transfer, future productization, and manufacturing use
- Mentor and provide day-to-day scientific direction to research associates and other team members as the program grows
REQUIREMENTS:
- PhD in stem cell biology, cell biology, bioengineering, developmental biology, or a related discipline with relevant experience; OR BS/MS with 3+ years of equivalent industry or pharma experience developing human stem-cell processes
- Extensive hands-on experience culturing and expanding human iPSCs, with strong practical understanding of maintenance, passage, morphology, culture quality, and common failure modes
- Strong experimental-design and process-development skills, including ability to systematically investigate sources of biological and process variability
- Demonstrated experience developing, optimizing, and troubleshooting complex stem-cell culture processes
- Demonstrated ability to establish and interpret analytical methods relevant to stem-cell identity, pluripotency, viability, growth, and process performance
- Strong understanding of biological factors governing iPSC state, growth, differentiation, and long-term culture quality
- Ability to independently analyze complex biological data, make technical decisions, and drive a program from early feasibility to robust process
- Exceptional scientific communication skills and ability to collaborate effectively with scientists and engineers from different technical disciplines
- Enthusiasm for a hands-on role in a small, fast-paced biotechnology company
PREFERRED QUALIFICATIONS:
- 3+ years industry or pharma experience developing iPSC expansion or culture processes intended for GMP, therapeutic, translational, or commercial manufacturing
- Experience using 3D culture techniques for iPSC expansion and/or differentiation, particularly hydrogel-, matrix-, or scaffold-supported culture
- Experience developing commercial research-use stem-cell products, standardized stem-cell workflows, media, culture systems, or related cell-based products
- Experience with stem cell line establishment, qualification, and banking
- Experience establishing process-related quality attributes and analytical strategies for stem-cell products or manufacturing processes
- Familiarity with GMP principles, controlled manufacturing environments, technology transfer, or manufacturing process development
- Familiarity with directed differentiation of iPSCs into therapeutically relevant cell types, particularly neural-lineage differentiation
- Experience developing or qualifying media or other critical culture inputs
