Scientific Process Specialist

2 days ago

Sligo, Sligo, Ireland beBeeScientific Full time
Job Title: Scientific Process Specialist

Location: Ireland, Sligo

This is a 12-month contract opportunity with a leading pharmaceutical company in Ireland. We are seeking a highly skilled Scientific Process Specialist to join our team in Sligo.

The ideal candidate will have a strong background in process science and engineering, with experience in the biopharmaceutical industry. You will be responsible for developing and transferring well-understood, robust, fit-for-purpose process control strategies for new product introductions (NPI).

Key Responsibilities:
  • Leverage detailed understanding of the science behind antibody drug conjugate (ADC)
  • Scientist SME for technology transfers and ongoing manufacturing.
  • Work with Research & Development and Drug Product Development functions to develop and transfer a well understood, robust, fit-for-purpose process control strategy for each NPI.
  • Author gap assessments, facility fit studies, process safety and risk assessments for NPI.
  • Design, on boarding, and testing of single use assemblies for use in sterile manufacturing of ADC.
  • Process SME for equipment selection and C&Q activities for any new equipment.
  • Author scientific reports and technical documentation and presentations to document and communicate project status to internal and external stakeholders.

Requirements:
  • Graduate degree in Chemistry, Biochemistry, Analytical Science or related discipline with extensive experience (MSc) or strong experience (PhD) in biopharmaceutical industry.
  • Experience with at scale ADC manufacturing including conjugation and fill finish operations.
  • Detailed understanding of the chemistry of large molecule and protein conjugation as evidenced by successful project execution
  • Desirable: Experience with new product introductions / technology transfers to fill finish manufacturing facility.

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