Senior Scientist

Desired Skills: HPLC,UPLC,Troubleshooting,Validation,tech transfer

PE Global is currently recruiting for a Senior Scientist for a leading multi-national Pharma client based in South Dublin.

This is a contract position.

The role:
The Analytical Methods and Strategy group is committed to supporting our global biologics analytical network with reliability, integrity, active engagement, and cross functional collaboration. The Method Lifecycle Group provides analytical oversight for the transition of programs entering the commercial space following clinical development. The Method Lifecycle Group is looking for a candidate with strong background and hands-on experience in separation and compendia methods. Successful candidate will take a role in defining new scientific approaches, data analysis, facilitate method transfers and method qualifications and validations. Critical thinking, trouble-shooting and attention to detail is a must. This is a non-GMP, part laboratory based and part office based role. Candidate will be required to plan & execute experiments as well as analyze data generated at other sites for method improvements. Ability to work collaboratively and across different functions in fast-paced environment is required. Hands on Qualification/ Validation experience in compliance with regulatory requirements is desired.

Responsibilities:
• Provide technical oversight and ownership of analytical methods. This includes partnering with analytical development to ensure method readiness for validation, assisting with validation protocols, gathering data generated by analytical development/QC labs and assisting with validation reports.
• Lead complex projects and lead a team of scientists to meet deadlines and collaborate with key stakeholder groups.
• Provide technical oversight of method revisions.
• Lead method transfers to QC GMP labs within and outside of BMS.
• Assist in obtaining critical reagent supply for assigned methods.
• Provide expert input during periodic review of method performance and work with team leader to design and execute remediation experiments and implement changes to existing commercial methods.
• Review method summaries in regulatory filings.
• Assist with Health Authority queries regarding analytical methods.
• Work collaboratively across organization and sites for method readiness, transfer, performance and trouble shooting in commercial environment.
• Work closely with all AMS team members to understand their deliverables to achieve organization goals.

Requirements:

• Pharmaceutical sciences or bio-analytical related degrees or experience is desirable. A BS with 10+ years or MS/PhD with 5+ years is desirable.
• Demonstrated trouble shooting and hands on experience with protein separation methods, for example, CE_SDS or iCIEF Electrophoresis, HPLC and UPLC Chromatography including Size-Exclusion chromatography, ion exchange and UVIS spectroscopy based technologies.
• Good understanding of the fundamentals of protein characterization methods such as peptide mapping, and carbohydrate analysis.
• Experience leading complex projects, projects teams and meeting tight deadlines
• Demonstrated critical based thinking skills and good organizational and presentation skills
• Experience of method validation and transfer is desired.
• Ability to work independently.
• Strong written and communication skills and experience working in a matrix organization.

Travel

• This position requires occasional domestic and international travel.

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***