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Associate Director-GMP Analytical | Meath

  • Sector: Science & Pharma
  • Contact Email: aisling.lane@collinsmcnicholas.ie
  • Job Ref: 19386

Associate Director-Biologics GMP Analytical

The Associate Director is a hybrid scientific/managerial role tasked with working closely with the group Director to define group strategy and to lead a team of scientists responsible for GMP biochemical assays. Experience leading small groups of technical personnel, leading projects, and defining group or departmental strategy essential. The group is not only responsible for the oversight of the execution of GMP release and stability activities, but also oversight of analytical method transfer from development labs, oversight of method transfers to commercialization sites and support of regulatory filings including INDs/IMPDs and BLAs.

You will be a team player with strong leadership skills and ability and passion for mentoring and managing scientists in a laboratory setting. 

Overview of Main Responsibilities (full job description available on request):

  • Demonstrated ability to develop talent through good mentoring skills
  • Demonstrated ability for taking initiative, creativity and innovation in problem solving
  • Productivity and efficiency working in GMP laboratories
  • Thorough understanding of GMP policies and procedures and proven experience working with Quality
  • Subject matter expertise in Ultrahigh Pressure Liquid Chromatography (UPLC)/High Performance Liquid Chromatography (HPLC), Capillary Electrophoresis, or other large molecule characterization technique
  • Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment
  • Established scientific reputation supported by publications and external presentations
  • Broad experience in analysis of biologics (e.g., Size Exclusion Chromatography (SEC), Ion Exchange Chromatography (IEX) and Capillary Electrophoresis (CE) techniques
  • Background in the development of new methods and sound scientific understanding of Quality by Design (QbD) and Design of Experiments (DOE) principles as well as data analysis and statistics

What the ideal candidate looks like:

  • Ph.D. in analytical chemistry/biochemistry or related field with a minimum of 4 years of experience in the pharmaceutical industry, M.S. in analytical chemistry/biochemistry or related field with a minimum of 7 years of experience in the pharmaceutical industry, or B.S. or equivalent in analytical chemistry/biochemistry or related field with a minimum of 10 years of experience in the pharmaceutical industry.
  • Previous experience leading and developing teams
  • Previous experience in a regulated GMP environment

What you will get in return:

  • Competitive salary.
  • Bonus.
  • Pension.
  • Healthcare.

For a confidential discussion and more information on the role, please contact Aisling Lane.

aisling.lane@collinsmcnicholas.ie

(021) 4320675