Role Description
We are a stealth-mode life sciences start-up, seeking a hands-on Scientist, Process Development to design and execute experiments that advance our clinical-stage cell therapy program. This role is central to our path to a Phase 2 clinical trial: you will own the development of an “industrialized” cell culture process, integrating automation and robotics, closing open unit operations, and generating the data packages needed to demonstrate process readiness.
This is a high-impact, bench-level role. You will be working alongside internal team members and external partners, bringing scientific rigor and a problem-solving mindset to one of the most technically demanding challenges in cell therapy manufacturing. If you are energized by the intersection of biology, engineering, and clinical translation in a lean start up environment, we would love to hear from you!
Key Responsibilities
R&D Process Development (85%)
- Serve as the in-lab lead for developing a phase 2-ready manufacturing process for our cell therapy product.
- Design and execute well-controlled studies independently, with accountability for experimental design, data analysis, and interpretation.
- Integrate automation, robotics, and liquid-handling platforms into cell culture workflows; develop and validate closed unit operations to replace open processes.
- Collaborate closely with Bioanalytical and Quality Assurance team members to build a well-characterized and controlled process.
- Develop and qualify critical process analytics and assays supporting process development and CMC readiness.
- Author and review data reports, experiment summaries, batch records, and SOPs in compliance with GMP documentation standards.
- Maintains meticulous records of experimental plans, raw data, and analyses in the electronic lab notebook (ELN) and company server.
- Trains and coordinate the activities of research associates contributing to process development workflows.
External Partner Collaborator (15%)
- Assist in co-development projects with third party technology partners to advance our
manufacturing capabilities
- Evaluate and conduct technical due diligence on external partner technologies and
platforms.
- Translate and implement external technologies into our cell therapy processes, provide technical training to third party groups as needed.
Qualifications:
- PhD in a relevant discipline (cell biology, bioengineering, pharmaceutical sciences, or related field)
- Hands-on experience in cell therapy development, including iPSC reprogramming, maintenance and differentiation.
- Experience with adherent cell culture and cell therapy manufacturing principles including GMP compliance.
- Demonstrated ability to design experiments, analyze complex datasets, and translate findings into actionable process decisions.
- Familiarity with GMP documentation practices, including SOPs, batch records, and deviation reporting.
- Comfortable operating in a lean startup environment as a self-directed, adaptable, hands-on contributor.
Preferred Experience or Qualifications:
- 3+ years of biotech/pharma experience, with a strong preference for cell therapy or biologics manufacturing and CMC.
- Experience in ophthalmological cell systems or ocular cell types (e.g., RPE) is strongly preferred.
- Experience with automation, robotics, or liquid-handling platforms (e.g., Hamilton, Tecan, Beckman) for high-throughput or closed-process workflows.
- Experience developing, implementing, or operating closed cell culture systems.
- Proficiency with advanced microscopy or automated imaging workflows.
- Experience applying Design of Experiments (DoE) methodology to process optimization.
- Familiarity with tech transfer from research-grade to clinical or GMP grade manufacturing.
The annual base salary we expect to pay is$110,000-$150,000. Individual pay decision depends on various factors such as responsibility of role, job duties/requirements, and relevant experience and skills.
We are an equal opportunity employer.
We do not discriminate on the basis of race, gender, religion, gender, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any characteristic protected under applicable law.
Pay: $110,000.00 - $150,000.00 per year
Benefits
Work Location: In person