Biologics Project Manager

JOB SPECIFICATION

Project Leader Biologics

LOCATION

County Mayo

REPORTS TO

Analytical Development Manager

One of our key clients, a well-established life sciences organisation, is seeking an experienced Project Leader to join its Biologics Division in County Mayo. Reporting to the Analytical Development Manager, you will lead the research, development and validation of new analytical methods, manage multiple GMP studies from study plan to final report, and act as the day-to-day technical point of contact for clients on current and new projects.

Key Responsibilities

■ Research and develop new analytical methodologies to meet client requirements and/or company strategic objectives.

■ Ensure all new methods are validated in accordance with ICH guidelines, where appropriate.

■ Draw up study plans and execute studies in strict accordance with the study plan and SOPs, ensuring full GMP regulatory compliance where appropriate.

■ Liaise with the Quality Department on audit responses, deviation reports and the compilation of study reports.

■ Lead laboratory investigations, where necessary.

■ Report project progress information to Management.

■ Provide technical training to the scientific team, as required.

■ Liaise with clients day to day regarding current and new projects.

■ Take part in regulatory and client audits.

■ Ensure all new equipment is qualified and validated in accordance with GMP and corporate validation standards and guidelines.

■ Generate new and update current standard operating procedures.

■ Generate risk assessments for projects as required.

Experience & Qualifications

■ Degree in a relevant science discipline (e.g. Chemistry, Biochemistry, Biotechnology, Immunology, Pharmaceutical Sciences or Molecular Biology); a PhD is preferred but not mandatory.

■ Minimum of 3 years' relevant experience in scientific research, preferably within a GMP-regulated environment (EMEA/FDA) in the pharmaceutical, medical device or CRO industry.

■ Experience in study design, assay development, optimisation, ICH analytical validation and project management.

■ Experience in analytical techniques (e.g. HPLC (ELS, CAD, UV/Vis etc.), UPLC, ELISA, SDS-PAGE, CE-SDS, UV/Vis, GC, flame photometry) is essential.

■ Ability to project manage multiple studies.

■ Knowledge of and experience with statistical software.

■ Strong problem-solving skills and the ability to work on your own initiative.