Senior Associate Quality Control

PE Global is currently recruiting for a Science Snr Associate for a leading multi-national Pharma client based in South Co Dublin.

This is a contract position.

Role:
This role will require the candidate to provide Process Development (PD) support primarily to the Forensics and Defect Laboratory at ADL. The candidate will establish themselves as an expert in forensic identification of Drug Product defects and maintain and produce extensive defect panels used to support automated and manual visual inspection of vial (liquid / lyophilised) and syringe packaged drug products.

Responsibilities:
• Leads / assists forensic investigation and identification of defects arising from drug product manufacture at ADL and write up of these investigations to cGMP standards.
• Be accountable for the maintenance, distribution and upkeep of extensive defect panels used for the set-up, training and characterisation of automated / semi-automated / manual finished drug product visual inspection equipment at ADL.
• Working as part of the PD laboratory team be expected to contribute to upkeep / maintenance of a GMP laboratory environment.
• Provide process development expertise for commercial drug product particle / defect identification and contribute to the maintenance of local and global particle / defect libraries.
Requirements:
• Third level bachelor’s degree in science, engineering or a relevant quality discipline with 2 – 4 years’ experience in a similar role OR Associate’s degree and 5 years of directly related experience.
• Experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as sterile processing, process characterization, inspection, tech transfer (to commercial DP sites) or validation.
• Be familiar with advanced microscopy (scanning electron microscopy) and spectroscopy (Fourier-transform infrared spectroscopy).
• Understanding of degradation mechanisms for biologics, analytical methods, laboratory practices, and basic statistical methods.
• Project management skills including the ability to manage multiple projects and evaluate project resource requirements.
• Strong knowledge of Quality systems, Drug Product Manufacturing and Validation.
• Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion.

Interested candidates should submit an updated CV.
Please click the link below to apply, or alternatively send an up to date CV to niamh.mcdonald@peglobal.net
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***