Team Horizon is seeking an ADC Process Scientist for our client based in Sligo. This is an exciting role to be part of an important NPI project where you will utilise your antibody drug conjugates expertise and work with various international stakeholders in R&D and Drug Product Development functions.
Why you should apply:
• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
• Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally
What you will be doing:
• Leverage detailed understanding of the science behind antibody drug conjugate 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
What you need to apply:
• Degree in Chemistry, Biochemistry, Analytical Science or related discipline with 3-5 years experience/MSc with 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
• Experience with new product introductions / technology transfers to fill finish manufacturing facility
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