Position type: Full time
Required education: Bachelor's Degree
Area(s) of expertise desired: Laboratory, cGMP, GTP, Quality Assurance, Quality Control, Validation

The Process Development Associate will be responsible for:

1. Development and scale-up of processes for the manufacture of cell-based therapeutics, including yield optimization, cost of goods reduction, media optimization and improvement of regulatory compliance
2. Development of final product formulations
3. Execution of raw material, in-process intermediate and final product stability programs
4. Writing of development SOPs , development process production records and technical reports
   

Requirements
The position requires a minimum BS degree in Biology or Biochemistry and a minimum of 3 years of relevant experience in the development and manufacture of cell-based therapeutics, cell culture-based biopharmaceuticals, or an equivalent combination of education and related experience. Expertise in cell-based product manufacturing process development and qualification, aseptic technique and experience operating and maintaining cell processing equipment, including bioreactors, Cell Factories, COBE Cell Processors, Cytomate Cell Processors and magnetic separation systems are additional requirements as are good oral communication skills, detail orientation, problem solving ability and teamwork. A willingness to work flexible hours and shifts is important.