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Job Details

Laboratory Manager-149707

Company: PPD
Location: Europe, Middle East & Africa-Ireland-Westmeath-Ath
Reference: 149707
Closing Date: 13 Jan 19
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

Laboratory Manager – Biopharm   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 with large and small molecules, including active pharmaceutical ingredients (API), drug products, inhaled products and other medical devices. ...

Requirements:

Laboratory Manager – Biopharm   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 with large and small molecules, including active pharmaceutical ingredients (API), drug products, inhaled products and other medical devices.

Due to further expansion of our site in Athlone, Ireland in 2018, we have a new opening for a Laboratory Manager in our BioPharm team.

About the Laboratory Manager position   PPD provides laboratory services that are designed to provide the best and highest level of service to our clients. Our lab employees are committed to quality results and strict compliance with regulatory standards. 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 Biopharm Associate Director in strategic planning, business development and expansion initiatives.   The Laboratory Manager will foster a positive and encouraging environment and motivate the team for success. In total, the Laboratory Manager will have accountability of a team of around 30, with this group continually growing.     Key responsibilities

  • Manages/directs work responsibilities of group leaders as well as prioritize projects and resources
  • Providing 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. 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

Qualifications

Skills and experience
  • Educated to a Bachelor's Degree level in a relevant area, ie chemistry, biochemistry
  • 10 years’ experience in the Pharmaceutical, Biotech, or Analytical Contract Laboratory industries within Stability, QC or analytical development departments
  • 5 years’ experience managing a team of technical staff 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 EMEA 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
  This role offers an excellent opportunity for someone who has previous leadership and management experience in GMP small molecule environment; who would now like to embrace a new technical environment/Biopharm specific products.   The successful candidate can look forward to job stability with a leading CRO that has experienced year-on-year growth. With future expansion plans, there is the opportunity to progress in your career with PPD at our Athlone labs. We offer a generous salary, medical insurance, pension, life insurance and relocation assistance to those qualified candidates based outside of the Republic of Ireland.
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Apply for this job: Laboratory Manager-149707

Contact Information:

Address:  PPD Cambridge
Granta Park
Great Abington
Cambridge

CB21 6GQ
England
Website:  Visit Our Web Site

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