Sep 18, 2021
PPD GMP Laboratory Athlone, Ireland is currently in construction stage for a large extension that will see us double our footprint and expand our Cell & Gene therapy testing capabilities in Ireland in the next three years. One of the largest Labs of its kind in Europe, our GMP laboratory based in Athlone, Ireland offers fully integrated solutions for product development and analytical development, including analytical testing services in method development, method validation, method transfer, release and stability studies. Our highly qualified GMP lab staff work across Biopharm, Cell / Molecular Biology, Small Molecule and Inhalation laboratory groups.
The role of Laboratory Manager is to provide leadership and support to Group Leaders, Scientists, and Project Managers in laboratory operations with tasks such as scheduling, resource management, technical and compliance related issues. They will plan, direct and implement improvements in systems, processes and procedures to increase efficiency, productivity and quality in the laboratory.
They will assist the Site management in strategic planning, business development and expansion initiatives.
Manages/directs work responsibilities of group leaders as well as prioritize projects and resources
Provides leadership and support to multiple employees in a positive and encouraging manner to motivate the team with drive, energy and enthusiasm
Reviews data for technical quality and compliance to protocols, methods and SOPs. Reviews and approves laboratory investigation, deviations, and QA facility and data audits. Leads client and regulatory audits
Reviews and approves study protocols, project status reports, final study reports and other project related technical documentation
Interacts with clients and business development on requests for proposals and project definition, Prepares, reviews, and approves bids and proposals, scope of work and pricing and negotiates with clients on timelines and pricing
Prepares and updates revenue projection reports and timesheet reports for revenue recognition and billing, evaluates resource utilization reports and project profitability
Assists upper management in strategic planning, budgeting, new capabilities development, makes recommendations on process improvement and fosters a GMP culture
Educated to a Bachelor's Degree level in a relevant area, ie chemistry, biochemistry.
10+ years' experience in the Biotech, Pharmaceutical or Analytical Contract Laboratory industries within Stability, QC or analytical development departments.
Experience in Cell and Gene Therapy is an advantage.
5+ years' experience managing teams of technical staff, including Lab supervisors, team Leaders / Lab leaders, with proven leadership record and evidence of team development.
Demonstrated strategic planning skills.
Knowledge of budgeting, forecasting and fiscal management.
Full understanding of cGMP requirements, client SOPs, ICH guidelines, EP and USP requirements and EMA and FDA guidance's.
Strong ability to perform root cause analysis and implement effective CAPA.
Knowledge and experience of a wide range of techniques, HPLC, UPLC, Electrophoresis (CE, iCE, SDS-PAGE), ELISA, spectrophotometry with proven technical troubleshooting and problem-solving abilities.
Knowledge and experience in Cell based assays, qPCR, ddPCR is an advantage.
Experience in drug product development, manufacturing and filing will be valued.
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture , where PPD truly value a work-life balance. We've grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.
Joining Bonus
Pension scheme
Annual Leave 25 days
Medical Health care cover
Life Insurance
Relocation package can be considered for candidates outside Ireland