Associate Director, Research & Development

About the role

The Advanced Regenerative Manufacturing Institute (ARMl)IBioFabUSA seeks an experienced leader to oversee R&D activities, manage a team of scientists and technicians, and collaborate with cross-functional teams.

Responsibilities

• 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.
• Support internal tech transfer and client interactions as needed.
• Manage external communications on projects as needed.
• 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.
• 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.

Requirements

• 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.
• 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.

Qualifications

• 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.

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.