Orion Group Life Sciences are currently recruiting a Process Scientist ADC (Antibody Drug Conjugate) on behalf of our Multinational Pharmaceutical Client based in Sligo on an initial 12-Month contract with huge potential to extend.
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.
Seniority level
Associate
Employment type
Temporary
Job function
Science
Industries
Pharmaceutical Manufacturing
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