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Associate Director Downstream Development - Biologics

Job Seekers Ireland Health, Science Pharmaceutical

Job Summary

  • Waterford
  • Permanent
  • 1808
  • May 05, 2022
  • Competitive
Job Description

The candidate will implement downstream development equipment into the lab to enable downstream process development and characterization.

Qualifications and Skills Required:

  • Bachelor's degree in engineering or an applied science is required. An advanced degree is preferred.
  • Over seven years of relevant pharmaceutical development and manufacturing experience in Biologics.
  • Experience working with downstream technologies at both lab and manufacturing scales.
  • Experience scaling up downstream processes and an understanding of the critical elements associated.
  • Completed tech transfers, have familiarity with gap analyses and risk assessments.
  • Understand IQ, OQ, facility as well as cleaning and process validation.
  • Hold a deep understanding of biological processes that includes critical and key process parameters, process and product based impurity generation and removal in support of scale-up and technology transfers.
  • Have a working knowledge of process development and/or manufacture of biological products using microbial and/or mammalian expression systems that includes hand-on experience with downstream technologies and understanding of chromatography dynamics and purification principles.
  • Demonstrate expertise in technology transfer and/or scale-up/down of processes.
  • Have a familiarity with quality systems and both FDA and EU regulations as they relate to process / product development and manufacture of biologics.
  • Experience with process characterization activities and Quality by Design (QbD) principles.
  • Have a demonstrated track record of delivering timely and consistent results and familiarity with project management skills for technical programs.