Process Development Scientist

ONK Therapeutics
San Diego, CA Full Time
POSTED ON 12/1/2022 CLOSED ON 4/27/2023

What are the responsibilities and job description for the Process Development Scientist position at ONK Therapeutics?

ONK Therapeutics is an innovative cell therapy company dedicated to the development of best-in-class, off-the-shelf/allogeneic chimeric antigen receptor (CAR) natural killer (NK) cell therapies for patients suffering from both hematologic and solid tumors. The company’s innovative approach to CAR therapy harnesses the innate biology of NK cells, whose function is further optimized through additional genetic engineering of the cells to improve their cytotoxicity and their function, even in the hostile tumor microenvironment.


We are looking for an energetic and highly motivated Scientist with demonstrated expertise in allogeneic cell therapy process development, with an emphasis on Natural Killer (NK) cell therapy. This candidate will be responsible to provide support to specific cell therapy programs in ONK’s pipeline. They will be responsible for establishing infrastructure, integrating innovative technologies, developing, and designing a robust and scalable end-to-end manufacturing process for uniquely engineered NK cells. This candidate will also lead the transfer of the in-house developed manufacturing process to external partners and collaborators for clinical manufacturing.


Essential Functions include but are not limited to:

  • Member of a cross-functional team supporting preclinical and clinical stage programs, focusing on CMC development
  • Contribute to the establishment of laboratory capabilities and systems
  • Design and lead and/or support phase-appropriate process development studies focusing on individual unit operations and overall manufacturing process for NK cell therapy products
  • Evaluate raw materials, culture systems, and scale-up options for NK cell therapy manufacturing processes
  • Lead and/or support process optimization efforts to increase process robustness, reduce costs, and improve yield, including evaluation and implementation of innovative technologies for specific manufacturing processes, as appropriate. 
  • Collaborate with the Manufacturing team to identify potential process improvements and design appropriate experiments to evaluate and implement those changes and drive successful technology transfer
  • Design and execute experiments independently; accurately record, analyse and communicate data to senior staff and team members
  • Present results in team meetings and deliver presentations to both small and large groups
  • Other duties as required, in line with a start-up environment, maximum flexibility is essential.


Education

Possession of a PhD, or a Master’s degree with 3 years of relevant experience, or a Bachelor's degree with at least 6 years of experience, preferably in an industry environment in one of the following disciplines: immunology, cancer cellular therapy, cancer immunology, or related field.


Experience and Skills

  • Prior experience with cellular therapies is essential. Experience with developing lymphocyte-based cell therapies, especially in an industry setting would is preferred. Experience of working with NK cells is desirable.
  • Experience with isolation and culturing of lymphocytes and/or NK cells from various sources is necessary.
  • Previous hands-on experience with equipment and unit operations typically used in Process Development or Manufacturing of cell therapy products is required.
  • Experience with cell culture, bioreactor operations and process scale up of cell therapy products is required.
  • Experience working with nucleic acid constructs, electroporation, transfections, viral or non-viral methods of modification of immune cells is preferred.
  • Experience in different techniques such as flow cytometry, ELISA, cell killing assays etc. typically used in immunology and cancer cell biology for characterizing modified immune cells is preferred
  • Excellent ability to document, organize and analyse data in a high quality and timely manner using relevant software and working knowledge of statistical and analytical tools is required. 
  • Ability to work independently and in a team setting is essential.
  • Effective communication skills (written and oral) and collaborative skills are required
  • Ability to mentor and guide junior lab scientists is preferred
  • Ability to be flexible, innovative, highly organized and manage multiple tasks in a growing fast-paced start-up environment is necessary.
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