Process Development Senior Scientist
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Join the process development team that supports commercial sterile vial filling at a leading biotechnology company in Juncos, Puerto Rico. You will design the studies and set the process parameters that keep aseptic manufacturing robust. This is a hands-on development role, not a documentation role.
What you'll do
Design and run process characterization and optimization studies for aseptic filling. Set and justify process parameters; troubleshoot commercial process issues. Analyze data in JMP or Minitab and recommend improvements. Author protocols, technical reports, investigations and change controls; support PPQ and tech transfer. Requirements Bachelor's degree + 5 years, Master's + 3 years, or PhD/PharmD (Engineering, Pharmaceutical Sciences, Biotechnology, Biology or Microbiology). Experience developing processes and establishing parameters for sterile drug product (not only validation). Aseptic processing, contamination control and GMP. JMP or Minitab, LIMS; bilingual English/Spanish. Benefits Contract: 6 months, with possible extension Shift: Administrative, Monday–Friday Start: Immediate
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