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Process Development Scientist

Worcester, MA, USA

Job Type

Full time



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.


· 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.


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.

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