Process Engineer I - Allogeneic Process Design

Job Description

This position works with both Allogeneic and Autologous process development partners including manufacturing, QC and analytical teams to discuss, and deliver against defined objectives. The candidate is responsible for planning, executing, analyzing, and presenting on studies related to cell therapy process development mainly but not limited to downstream process including formulation, fill/finish and cryopreservation. This role authors and reviews technical protocols, reports, and procedures.

Primary Responsibilities:

• Independent functioning as an engineer, capable of planning, executing, analyzing, and reporting on studies related to formulation, fill/finish and cryopreservation, cell banking and upstream cell therapy process.
• Performs hands on lab work to execute studies across multiple unit operations including process development, characterization, and new technology assessment.
• Manages samples and inventory related to each experiment.
• Evaluate impact of process parameters on product performance and develop processes to support early and late-stage process dev. Studies.
• Compiles and analyzes data, preparation of presentation and technical reports.
• Author and review process development study plans, reports, SOPs, and batch records Interacts with Manufacturing, MSAT, Quality and external partners as needed.
• Strong team member and contributor to overall cell therapy process characterization, development, and validation activities individually or in a team.
• Design and validate novel strategies for autologous or allogeneic cell therapy platforms.
• Collaborates with Analytical Development to meet testing needs.
• Facilitates team building and communication.

Basic Requirements:

• MS/MA Degree in Biochemical Engineering, Chemical Engineering, Biotechnology, or related fields with 0+ of cell culture and/or cell therapy manufacturing and process development experience OR
• BS/MA Degree in Biochemical Engineering, Chemical Engineering, Biotechnology, or related fields with 2+ of cell culture and/or cell therapy manufacturing and process development experience OR
• AS/AA Degree in Biochemical Engineering, Chemical Engineering, Biotechnology, or related fields with 4+ of cell culture and/or cell therapy manufacturing and process development experience OR
• High School Diploma with 5+ of cell culture and/or cell therapy manufacturing and process development experience

Preferred Requirements

• Excellent interpersonal, presentation, and written communication skills
• Excellent skill sets in data management and statistical analysis tools (JMP/ R/Minitab).
• Ability to work and collaborate in cross functional teams, research, development, manufacturing in a fast pace, dynamic team setting.
• General understanding of Cell Therapy process flow and unit operations and aseptic cell culture processing experience are required.
• Practical demonstration of hands-on process development including use of statistical design of experiment.
• Ability to think critically with troubleshooting and problem-solving skills.
• Accommodation of occasional weekend work