Senior Director, Cell Therapy R&D & Process Development

Advanced Regenerative Manufacturing Institute (ARMI) | BioFabUSA; Manchester (NH); On-site; USD 120,000 - 180,000; Full time

Job summary

ARMI BioFabUSA in Manchester, NH seeks an independent leader to oversee diverse R&D teams focused on cell therapies, analytical assays, and early‑phase manufacturing processes. The role emphasizes GLP/safety, root‑cause analysis, CAPA, and collaboration with Quality, Facilities, and Project Management to meet milestones and grant program goals.

You will mentor scientists and technicians, drive technology transfer, document ELN entries, SOPs, and reports, and help shape studies from design

Qualifications

• Biotechnology, Biology, Biochemistry, or related life science degree.
• PhD preferred with 4‑6 years of experience in human stem cell biology, tissue engineering, or analytical assay development.
• Experience with GMP considerations and FDA regulatory familiarity.

Responsibilities

• Oversee daily R&D operations and ensure milestones.
• Ensure GLP and safety standards compliance.
• Coach team on root‑cause analysis, documentation, and CAPA.
• Collaborate with Quality, Facilities, and Project Management.
• Manage multiple projects with timelines and deliverables.
• Support tech transfer and client interactions.
• Handle external communications on projects.

Skills

Cell biology

RNASeq

Flow cytometry

Statistical analysis (ANOVA)

Cell culture techniques

ELN usage

Project management tools

Education

Biotechnology, Biology, Biology-related life science degree

PhD in related life sciences

Tools

GraphPad

JMP

ELN

Job description

Overview

The Advanced Regenerative Manufacturing Institute (ARMl)IBioFabUSA is a Member-based non-profit, member-driven, public-private partnership with a mission to advance the bioeconomy and transform the future of human health. ARMI provides technical and wrap-around commercialization services to companies seeking to advance technologies that will contribute to this impact.

Overview

The Advanced Regenerative Manufacturing Institute (ARMl)IBioFabUSA is a Member-based non-profit, member-driven, public-private partnership with a mission to advance the bioeconomy and transform the future of human health. ARMI provides technical and wrap-around commercialization services to companies seeking to advance technologies that will contribute to this impact.

The Impact That You Will Make

ARMI is seeking an independent, self-starter with experience overseeing diverse research teams including analytical and early-stage process development focused on advancing cell therapies. The successful candidate will be responsible for oversight of R&D activities, management of personnel to ensure milestones and timelines are met, and collaboration with leadership to develop study plans and hypotheses. This individual will lead a team of scientists and lab technicians to develop early phase manufacturing processes and analytical assays as part of grant programs, for internal transfer, or in collaboration with external parties. This role requires particularly strong attention to detail, a deep understanding of analytical tests, extensive experience with stem cell biology, and the ability to think outside the box to solve problems creatively and proactively. The ideal candidate will have experience with hPSCs, cell and tissue engineering, flow cytometry, RNASeq, assay development, ELNs, SOP drafting, root-cause analysis, and other documentation.

Your Role

Leadership and Oversight

• Lead daily R&D operations/tasks.
• Ensure team compliance with GLP and safety standards.
• Coach team members on root-cause analysis, documentation, and CAPA.
• Collaborate with cross-functional teams including Quality, Facilities, and Project Management.
• Manage multiple projects simultaneously and confidentially while meeting critical timelines and deliverables.
• Work with management to develop robust, well controlled, hypothesis driven research.
• Support internal tech transfer and client interactions as needed.
• Manage external communications on projects as needed.
  
  

Process Execution & Documentation

• Conduct technology transfers within ARMI's facility.
• Draft and review/approve accurate SOPs, technical documentation, ELN entries, and detailed reports as needed.
• Monitor research progress through experimental design and data analysis.
• Troubleshoot issues, perform root cause analysis, and implement corrective actions.
  
  

Instrumentation & Maintenance

• Collaborate with Operations, service engineers, and vendors for process equipment, calibration, preventative maintenance, optimization, and upgrades.
• Ensure proper training of laboratory personnel on process and safety procedures.
  
  

Your Skills And Experiences

Education & Experience

• Biotechnology, Biology, Biochemistry, or related life science degree. PhD with 4-6 years of experience in human stem cell biology, tissue engineering, and/or analytical assay development.
• Familiarity with phase appropriate GMP and relevant FDA regulations and requirements.
• Demonstrated experience leading teams and cross-functional interactions.
  
  

Technical Skills

• Extensive cell biology experience
• Experience with process equipment including a variety of cell culture technologies from flasks to stirred tank reactors, counterflow and continuous centrifugation, etc.
• Experience with ELN, data analysis software (e.g., GraphPad, JMP), and statistical methods (e.g. ANOVA).
• Familiarity with RNASeq or other sequencing modalities and flow cytometry
• Familiarity with Phase appropriate application of regulations
• Familiarity with project management tools and techniques
  
  

Professional Qualities

• Commitment to quality, scientific integrity, and company mission
• Strong analytical and proactive problem-solving skills with a strong attention to detail
• Excellent written and verbal communication abilities
• Ability to work independently and manage competing priorities
• Team-oriented mindset with collaborative cross-functional approach
  
  

Working Conditions

• BSL2 and cleanroom laboratory environment with exposure to biologics, chemical reagents, and analytical instruments
• Overtime, weekend, and holiday coverage may be required
• Occasional overtime may be required to meet project deadlines
• Some travel may be required for conferences, training, or client meetings
  
  

By applying, I understand that any offer of employment is contingent upon the successful completion of a background check, in accordance with applicable laws.