Scientist
JHNA · Manchester, NH · 1 mo ago
AnalystFull-time
The Impact That You Will Make
ARMI is seeking an innovative, motivated scientist to join our phase-appropriate cell therapy manufacturing team. The successful candidate will use their experience and expertise to perform daily manufacturing and process development activities ensuring the generation of high-quality, cell-based therapy products for use in both research and Phase 1 clinical trials. This individual will work within a team of scientists and technicians working to scale-up processes and bring early phase manufacturing processes into phase-appropriate compliance with Good Manufacturing Practices (GMP).
Your Role
- Leadership and Oversight
- Provide guidance to technicians.
- Collaborate with cross-functional teams including Quality, Facilities, and Project Management.
- Engage on multiple projects simultaneously and confidentially while working with the team to meet critical timelines and deliverables.
- Work with management to ensure robust work schedules.
- Process Execution & Documentation
- Comply with GMP and safety standards.
- Perform technology transfers into and within ARMI's facility.
- Draft accurate SOPs, technical documentation, and batch records as needed.
- Report production deviations and manufacturing issues, performing root cause analysis, and aiding in the implementation of corrective actions.
- Instrumentation & Maintenance
- Collaborate with Operations, service engineers, and vendors for process equipment, calibration, preventative maintenance, optimization, and upgrades.
- Maintain proper training on process and safety procedures.
Your Skills and Experiences
- Education & Experience
- A Biotechnology, Biology, Biochemistry, or related life science degree. BS/MS with 2-4 years of experience in cell therapy manufacturing in an MSAT or GMP production role.
- Demonstrated experience working within cross-functional teams.
- Technical Skills
- 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.
- 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
- Shift: Sunday – Wednesday, 10-hour days
- Some holiday coverage may be necessary
- Occasional overtime may be required to meet project deadlines
- Some travel may be required for conferences, training, or client meetings