Designs and implements process development (PD) experiments with minimal supervision, both upstream and downstream unit operations. Maintains processes according to the requirements for drug substances and drug products as mandated by the FDA, EMA and MHRA. Maintains excellent electronic notebooking skills and generates reports that summarize all process development activities. Develop production batch records based process development activities in collaboration with the Quality Assurance Department of Children's GMP, LLC. If needed, provides support in cGMP manufacturing.
Bachelor's degree in Biological Sciences, Chemical Engineering or Bioprocessing or related field required
MS or Ph.D. preferred.
Eight (8) years of related experience with a BS. Four (4) years of related experience with a MS. No related experience required with a Ph.D. Experience in process development in a cGMP environment is preferred
St. Jude Children's Research Hospital does not accept unsolicited assistance from search firms for employment opportunities. Please do not call or email. All resumes submitted by search firms to any employee or other representative at St. Jude via email, the internet or in any form and/or method without a valid written search agreement in place and approved by HR will result in no fee being paid in the event the candidate is hired by St. Jude.