Process Scientist

Process Scientist

A 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 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 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 execution
  Desirable: 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)