Vice President of Process Development

The successful candidate will lead the Process Development team, contribute to the development and establishment of an in-house manufacturing process for the company’s T cell platform. The position will work closely with experienced scientists in a dynamic, fast-paced and highly collaborative environment.

Responsibilities:

  • Manage process operations and performance including manufacturing of lentiviral vector and T cell product;
  • Identification and development of Standard Operating Procedures (SOPs), Master Batch Records, and Product Specification Sheets;
  • Generate, analyze experimental data and present results, document study results for enabling clinical studies;
  • Oversee assay validation and quality control;
  • Provide accurate production forecasting with continuous improvement through capacity optimization;
  • Support technology transfer of established process and communication with clinical manufacturing organizations;
  • Maintains production schedule with mindfulness of corporate goals, timelines, and budget initiatives;
  • Maintain a high level of professional expertise through familiarity of latest scientific and technology advancements, practice, and regulations in the T cell therapy and lentiviral vector field.

Qualifications:

  • Ph.D. in chemical engineering, bioengineering, or related discipline with a minimum of 8 years of manufacturing experience, preferably in a biotech or pharmaceutical setting
  • Expertise in cell culture process development and process automation (primary and mammalian cell lines), preferably with human T cells
  • Experience in lentiviral vector production, and upstream and downstream process development
  • Understanding of cGMP requirements for clinical manufacturing
  • Demonstrated success in identifying, negotiating and overseeing outsourced clinical operations and vendors
  • Outstanding critical thinking and organizational skills; excellent communication skills a must
  • Proven track record of scientific accomplishments demonstrated by publications in high-impact journals

Interested candidates should send their resume to careers@tcr2.com