Process Engineer I/II – Downstream, Process Development & MSAT

Santa Monica

Neogene Therapeutics is a pre-clinical stage biotechnology company aiming to change the paradigm of treatment for solid cancers. Neogene is developing novel technologies to enable the engineering of ‘designer T cells’ with neo-antigen specificities that display an optimized ability to seek and destroy cancer cells.

We are seeking a highly motived, data-driven engineer to join our Process Development (PD) team as a Sr. Process Engineer I. The primary focus of this position is to support development and optimization of manufacturing processes with emphasis on harvest, fill/finish, and cryopreservation of the cell therapy drug product. The Sr. Process Engineer I will also be expected to develop, design, and participate in new platform technology evaluation and implementation. The successful candidate should have a knowledge of basic engineering principles, bioprocess development, and cGMP manufacturing. Additionally, the candidate should also have experience in primary cell culture and cryopreservation (T cells preferred), in different formats.

Responsibilities include, but are not limited to:

  • Execution of process development studies to develop, optimize, scale-up and transfer GMP cell therapy manufacturing processes
  • Perform cell culture of T cells in multiple formats including flasks, bags, and bioreactors
  • Development of robust downstream platform technologies including not limited to product harvest, formulation, cryopreservation, and fill finish for cell therapy product
  • Evaluate improvements to clinical fill processes/equipment and closure systems.
  • Define appropriate studies regarding process investigations as required to support manufacturing activities and regulatory filings
  • Collaborate within the project team to interpret study results and contribute to technical discussions for subsequent study design.
  • Prepare and review experimental proposals, technical reports, SOPs and manufacturing batch records.
  • Work collaboratively within PD group and cross-functionally with other groups to meet Tech Ops organization goals
  • Other responsibilities as assigned

Requirements:

  • MS degree in Biochemical Engineering, Biomedical Engineering, Biotechnology or related field with 1+ years relevant industry experience or BS degree with 2+ years relevant industry experience.
  • Experience in technical development of cell and gene therapy or biologics in early and late development setting
  • Hands-on experience in cell and gene therapy, specifically in T cells is highly desirable
  • Experience with clinical-scale cryopreservation of T cells is highly desirable
  • Knowledge of cGMP manufacturing and regulations and practical experience in GMP operations is highly desirable
  • Knowledge of QbD, DOE and appropriate statistical analysis for process development
  • Ability to think critically, analytically and have demonstrated troubleshooting and problem-solving skills based on deductive reasoning

We offer the opportunity to join a highly dynamic growth-stage biotech company. You can expect a collaborative environment created by a team with deep scientific expertise and an industrial track-record in T cell therapies. We value proactive team-players who pursue their goals with dedication, endurance, and a daring mindset. If you share our commitment to make a difference to patients in need, we can provide a unique opportunity to be a major contributor to the success of a well-positioned, well-financed growth-stage biotechnology company.

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