Process Development Engineer - TP140552

TES is hiring 1 temporary Process Development Engineer 4.

• Duration: Assignments typically run for approximately 3-6 Months.
• Compensation and Benefits: $51.77/hr (exempt), including paid holidays and vacation/sick leave. Mid-level benefits are available.
• Work Schedule: Monday - Friday 8:00am - 4:30pm, but can vary.
• Location: 100% on Site

The R&D Engineer 4 uses advanced engineering concepts to address complex technical challenges for cell-based therapy production improvements and design. They are expected to possess a comprehensive understanding of the field and exhibit expertise in cell-based therapy technologies and scientific principles, enabling them to tackle problems that lack precedent or clear structure. Their responsibilities may extend to managing projects, formulating strategies, and overseeing the implementation of ACTL policies and processes. This senior technical contributor must also ensure that their activities align with the organizational goals and deliver solutions that meet the evolving needs of the department. Performs other duties as assigned.

Uses advanced engineering concepts and campus objectives to perform highly specialized engineering work on a training and/or research program. Regularly works on highly complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises independent judgment in selecting methods, techniques, and evaluation criteria for obtaining results.

• Eleven years of related experience, education/training, OR an Advanced degree in related area plus five years of related experience/training.
• Advanced knowledge of specialized design work as well as the overall field. Academic and/or industry background and experience in the selected area of research.
• Proficiency with several of the following technologies: cell processors such as CliniMACS plus or Prodigy systems, transfection/transduction technologies, and analytical methods such as ELISA, qPCR, ddPCR, flow cytometry.
• Advanced knowledge associated with the planning, development, and fabrication of engineering systems. Hands-on experience in cell therapy product engineering and production process development and analysis. Extensive knowledge of pluripotent cell-derived therapeutics and production technologies, of gene editing principles and cell engineering platforms.
• Strong creativity and problem-solving abilities to apply principles, practices, and procedures within discipline to complete difficult assignments.
• Strong project management skills needed to assume responsibility for accomplishment of research objectives.
• Advanced communication skills, both written and verbal, to convey complex information in a clear and concise manner.
• Ability to work in a highly collaborative manner; readily assess complex challenges and barriers and recommend effective resolutions.
• Strong understanding of GLP and GMP standards and U.S. Food and Drug Administration guidelines and regulations.
• Must have experience supporting process development as a seasoned, experienced R&D Engineer.

• Doctorate in related area and/or equivalent experience training preferred.
• Industry experience of production process development preferred.
• Advanced interpersonal and presentation skills.

• Willingness to work in BioSafety Level II environment where biological (including infectious agents and blood-borne pathogens) hazards are present.
• Willingness to work with human pluripotent stem cells and viruses that are infectious to humans, including adeno-associated viruses, sendai viruses, and lentiviral vectors which are derived from human immunodeficiency virus (HIV).
• Must be able to work various hours and locations based on business needs.
• Employment is subject to a criminal background check.