Process Engineer


We are currently seeking a Process Engineer, Cell Therapy Development. This position will support process development and stem cell therapy manufacturing related to induced pluripotent stem cell (iPSC) derived dopaminergic progenitor cells of a first-in-human clinical trial for the treatment of Parkinson’s Disease sponsored by Aspen Neuroscience, Inc. This newly created role reports to the Senior Director of Manufacturing.

Responsibilities will include:

  • Work within a cross-functional team of scientists, bioinformatic specialists and research/development associates to:

    • Optimize cryopreservation protocol and develop final product fill/finish, shipping and packaging with container closure system integrity and stability evaluation

    • Development of new processes or refinement of existing ones, e.g. for closure or automation of unit operations

    • Execute drug delivery system compatibility and consistent cell dose delivery bench study

    • Support manufacturing process qualification and aseptic process simulation runs

    • Prepare SOP, qualification protocols, reports and other documentation

    • Other duties and responsibilities as assigned

Essential Qualifications and Skills required:

  • Degree in Chemical Engineering, Biochemical/Biomedical Engineering or a related discipline. Advanced degree is a plus

  • 5+ years of hands-on experience in the biotechnology, biologics or pharmaceutical industry (GMP environment is a plus)

  • Must have a solid understanding of and experience with:

    • Aseptic tissue culture of mammalian cells (pluripotent stem cells is a plus)

    • Scale-out and process closure for cell culture (cryobiology is a plus)

    • Container closure and Drug delivery systems (e.g. injection cannula)

  • Working knowledge of:

    • cGMP guidelines

    • Design of Experiments (DoE) and/or Design Controls

    • Execution of Qualification/Validation protocols

    • Statistical analysis and modeling software

  • Strong organizational and documentation skills

  • Must be willing to work flexible hours

 

Aspen Neuroscience, Inc. offers a competitive compensation package, as well as time-off in addition to Company observed holidays, and Medical/Dental insurance benefits. We promote a culture in which employees are respected and rewarded for hard work, innovation, personal initiative, and teamwork.

To apply, please send your cover letter and resume to tgorba@aspenneuro.com, Subject: Process Engineer.