Associate Director of Biomanufacturing

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 Manufacturing, Science and Technology (MSAT) experience to lead our phase-appropriate cell therapy manufacturing team. The successful candidate will be responsible for oversight of daily manufacturing operations ensuring the generation of high-quality, cell-based therapy products for use in both research and Phase 1 clinical trials. This individual will lead a team of scientists and technicians working to bring early phase manufacturing processes into phase-appropriate compliance with Good Manufacturing Practices (GMP). This role requires particularly strong attention to detail, a deep understanding of phase-appropriate GMP manufacturing, and the ability to think outside the box to solve problems creatively and proactively. The ideal candidate will have experience with tech transfer, aseptic technique and operations within a controlled manufacturing environment, SOP/Batch Record drafting, audit response support, deviations and CAPAs, continuous improvement activities, and other aspects of contract manufacturing.

Your Role

Leadership and Oversight

• Lead daily manufacturing operations/tasks.
• Ensure team compliance with GMP 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 the broader management team to develop work schedules ensuring robust coverage.
• Support regulatory submissions and client/internal/regulatory audits as needed.
• Manage external communications on project as needed.

Process Execution & Documentation

• Conduct technology transfers into and within ARMI's facility.
• Draft and review/approve accurate SOPs, technical documentation, batch records, and detailed reports as needed.
• Monitor process performance through data analysis.
• Investigate production deviations and manufacturing issues, performing root cause analysis, and implementing 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. BS/MS with 10-15 years of experience or PhD with 4-6 years of experience in cell therapy manufacturing in an MSAT or GMP production role.
• Familiarity with phase appropriate GMP and relevant FDA regulations and requirements.
• Demonstrated experience leading teams and cross-functional interactions.

Technical Skills

• Extensive proficiency with cell therapy manufacturing.
• Experience with clean room operations for cell therapy production.
• Familiarity with process equipment including a variety of cell culture technologies from flasks to stirred tank reactors, counterflow and continuous centrifugation, etc.
• Demonstrated knowledge of GMP regulations, including change control, deviations, CAPA, etc.
• Understanding process modeling, data analysis software (e.g., Minitab, JMP), and statistical methods (e.g. ANOVA).
• Experience with Phase appropriate application of regulations
• Familiarity with project management tools and techniques

Personal Attributes

• 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

• Cleanroom laboratory environment with exposure to biologics, chemical reagents, and analytical instruments
• 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.