Requirements: English
Company: ireland.xpatjobs.com
Region: Sligo Sligo County
Process ScientistA West of Ireland based Pharmaceutical Multinational is seeking to recruit a Process Scientist ADC (Antibody Drug Conjugate) to join a team of 3 other Process Scientists, responsible for the tech transfer of the ADC process; generate documents (GAP assessments, cleaning assessments etc), CAPA's, master batch records, generation of process flows, etc. This offers an excellent opportunity to advance your career within a dynamic environment.Responsibilities:• Leverage detailed understanding of the science behind ADC manufacturing and the site manufacturing process.• 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 CQ 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 with specific academic knowledge/experience in ADC- Previous hands on experience in ADC (Antibody Drug Conjugate) manufacturing facilities and/or experience in upstream processing, UFDF, mixing, single use and chromatography- Detailed understanding of the chemistry of large molecule and protein conjugation as evidenced by successful project executionDesirable: Experience with new product introductions / technology transfers to fill finish manufacturing facility.For more information and a full job spec contact Nicola on (phone number removed) or email your CV in the strictest confidence to (email address removed)