Process Scientist - Sligo

The role:

PE Global are currently recruiting for a NPI Process Scientist for our client site in Sligo on a 12-month initial contract:

• Process Scientist ADC (Antibody Drug Conjugate)
• Job Dept: Technical Operations
• Reports to: NPI Technical Manager

Responsibilities:

• Leverage detailed understanding of the science behind antibody drug conjugate (ADC) manufacturing and the manufacturing process as manufacturing plant-based Process 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 new product introduction (NPI).
• Author gap assessments, facility fit studies, process safety and risk assessments for NPI.
• Design, onboarding, 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.
• Understand and ensure compliance with safety, regulatory and compliance expectations.
• Other duties as assigned.

Requirements:

• Graduate degree in Chemistry, Biochemistry, Analytical Science or related discipline with 3-5 years' experience (MSc) or 2-5 years' 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.