Arcellx is seeking a highly motivated individual with cell culture experience to work on innovative T cell therapy for cancer treatment. As a Scientist in the Cell Product Sciences Group, you will provide process development support for new INDs, technology transfers, process validations and GMP manufacturing for Arcellx’s engineered autologous T cell therapy products. Additionally, you will draft and review protocols, production procedures, and process development reports. You will work with the Cell Product Sciences team to design and scale-out cell therapy processes, manage equipment qualification as well as draft documentation for regulatory filings to advance Arcellx’s product portfolio
Essential Duties and Technical Proficiencies:
- Hands on execute and collaborate on process design laboratory studies to support process development, optimization and further characterization and essential process improvements.
- Perform hands on work in a cell culture lab and process training for GMP clinical production.
- Participate and influence a cross-functional development team to advance CMC activities
- Perform process analysis and trend process performance
- Develop manufacturing processes for cell therapy products
- Perform statistical analysis including design of experiments (DOEs) as appropriate
- Write and review technical documentation from writing technical SOPs, draft manufacturing batch records, technical reports and summary reports.
- Create slides and supporting data to communicate results to senior leadership.
- Other duties as assigned
- PhD Degree in Biology, biochemistry, chemical engineer, biomedical engineering or biotechnology degree or related discipline with 1-3 years of pharmaceutical manufacturing, technology transfer & process development experience required
- Demonstrated cell culture and aseptic processing experience is required including basic cell culture lab techniques such as cell passaging, cryopreservation, formulation of media, aseptic technique using a BSC, cell counting, and managing reagents.
- Practical knowledge of cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices.
- Practical demonstration of hands on process development including use of statistical design of experiments is required. Experience with bioreactors is desired.
- Mastery of scientific and engineering principles
- Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products and process development
- Ability to think critically, and demonstrated troubleshooting and problem solving skills
- Excellent interpersonal, verbal and written communication skills are required.
- Ability to function efficiently and independently in a changing environment
- Self-motivated, strong sense of responsibility, and willing to accept temporary responsibilities outside of initial job description
- Well-developed computer skills
- High energy level and a positive outlook coupled with the requisite “can do” attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles
- Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
- Ability to work and collaborate in cross functional teams, research, development, manufacturing in a fast pace, dynamic team setting
Job Type: Full-time
- bioprocessing: 1 year (Preferred)