Scientist I-II/ Senior Scientist Cell Process Development

Arcellx is a venture-backed, early-stage biotech company focused on the development of novel cell-based cancer therapies.  The company is located in Gaithersburg, Maryland and has assembled a team of biotechnology professionals with expertise in biologics discovery, characterization, and development.  Lead products will incorporate proprietary technologies that enhance tumor-specific killing by genetically engineered human immune cells.

Primary Objective

Key contributor to the development of phase-appropriate manufacturing processes for Arcellx cell therapy products. The candidate will bring to the role a good understanding and expertise with cellular bioprocessing technologies, process development, and technical transfers. The candidate will be a highly motivated engineer/scientist with good laboratory skills, who will work on process development initiatives in process design, GMP adaptation, process characterization, unit operation research, technology transfer to CMOs, data tracking and trending, and management of process technical documents.  The successful candidate will be working across functional areas such as research, development, clinical, and manufacturing to produce cellular therapeutics for the Arcellx portfolio.

MAIN ACCOUNTABILITIES:

The main responsibilities will include but are not limited to:

• Organize, plan, and execute laboratory experiments to support cell culture processes development and GMP processes transfer activities to enable clinical manufacturing
• Lead cell culture process development initiatives to enable process improvements, characterize the process, and develop the process control strategy.
• Aid in design and creation of development plans contributing to process definition and process lock.
• Work with MSAT scientists on cell processes GMP adaptation
• Critically analyze process data and author technical reports and standard operating procedures
• Summarize and present data in group meetings and contribute to group discussions
• Help to conduct Technical Transfers to CMOs and provide manufacturing science and technology support to ensure robust production in GMP environment
• Review SOPs, raw material specifications, development reports and protocols at Arcellx and CMOs.
• Maintain accurate and detailed laboratory notebook and documentation
• Participate in management of laboratory equipment and supplies
• Work independently as well as with other team members to perform and troubleshoot experiments or assay performance
• Contribute to relevant CMC sections of IND/BLA and other regulatory documents.
• May supervise a team of Research Associates

Preferred Qualifications:

• Scientist I: MS in Chemical Eng., Biological Engineering, Biomedical or Biochemical Engineering with 5+ yrs. of relevant experience or PhD with 0-3 yrs. of relevant experience
• Scientist II: MS in Chemical Eng., Biological Engineering, Biomedical or Biochemical Engineering 7+ yrs. of relevant experience or PhD with 3+ yrs. of relevant experience
• Senior Scientist: MS in Chemical Eng., Biological Engineering, Biomedical or Biochemical Engineering 10+ yrs. of relevant experience or PhD with 6+ yrs. of relevant experience
• Strong scientific and operational background in implementation of bioprocess unit operations and aseptic cell culture.
• Strong understanding of process development, technical transfer, and GMP requirements.
• Experience with T or B-cell cultures is a plus

Competencies:

• Detail oriented, good documentation practices, technical writing, and verbal communication skills
• Must have strong organizational skills and an ability to handle track and execute multiple priorities
• Possess strong problem solving and analytical skills and be an independent and creative thinker.
• Ability to navigate and be successful in a fast-paced, highly matrixed work environment.
• Highly motivated, with willingness to acquire new skills and ability to learn quickly
• Strong engineering/scientific understanding, and ability to apply knowledge to process development
• Possess strong problem solving and analytical skills and be an independent and creative thinker
• Ability to navigate and be successful in a fast-paced, highly matrixed work environment.
• Interpersonal and leadership skills to work with teams in different functions and organizations

Without exception, applicants must submit both a cover letter and resume to be considered for these positions and must have experience in one of the fields listed above.