Scientist I/ Scientist II Cell Process Development

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.

ABOUT ARCELLX:  Arcellx (http://www.arcellx.com/) 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.

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.
• Aid in design and creation of development plans, contributing to process definition, process lock and optimization of process steps.
• Critically analyze process data and author technical reports and standard operating procedures.
• Summarize and present data in group meetings and contribute to group discussions.
• Conduct Technical Transfers to CMOs and provide manufacturing science and technology support to ensure robust production in GMP environment.
• Review batch records, SOPs, raw material specifications, development reports and GMP 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: BS in Chemical Eng., Biological Engineering, Chemistry, or Biology related discipline with a minimum of 7 yrs. of relevant experience, MS with 5-7 yrs. of relevant experience, or PhD with 0-3 yrs. of relevant experience
• Scientist II: BS in Chemical Eng., Biological Engineering, Chemistry, or Biology related discipline 10+ yrs. of relevant experience, MS 7+yrs of relevant experience, or PhD with 3+ 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