Description
Overview
The successful candidate will join the Process Development group in the preparation of robust processes for various clients and their technologies including CAR-T, mRNA, and lipid nanoparticles (LNP). The PD Scientist’s responsibilities will include the design and execution of process development experiments, analyzing data and presenting results for a wide range of programs. The position represents an excellent opportunity for career development, working closely with peers and senior internal and external personnel in a fast-paced and highly collaborative environment.
Responsibilities
· Design, execute, and facilitate studies to understand process performance.
· Liaison between PD and manufacturing. Prepare reports and batch records that will become part of the tech transfer package to send to manufacturing.
· Assist in training manufacturing personnel on CAR-T, mRNA and LNP processes.
· Support cross-functional projects with analytical development and manufacturing stakeholders.
· Maintain organized documentation of experimental procedures, utilize lab notebooks and batch records, maintain databases.
· Evaluate new proposals for feasibility within the Process and Analytical Development groups and for eventual transfer to manufacturing.
Requirements
About You
Education: MS or Ph.D. Degree in Biology/Biomedical Engineering/or related scientific discipline
Qualifications and Experience:
· 4 - 7 years of experience in Biotechnology industry, research, or academics, with at least three years in a process development role, either biologics and/or cell therapy.
· Experience in cell culture/aseptic technique required.
· Experience with CAR-T and/or HSC production and familiarity with CliniMACS, Fresenius Kabi, X-Lab, and flow cytometry instrumentation is highly preferred.
· Experience with GMP principles and working within a Quality Management System.
· Experience with Design of Experiment (DoE) software such as Jmp or Minitab a plus.
Skills and Abilities:
· Innovative thinking to solve problems and find creative solutions.
· Strong interpersonal and diplomatic skills
· Attention to detail, organizational skills, and ability to multi-task in a dynamic environment.
· Identify opportunities for process improvements and communicate appropriately.