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Analytical Team Lead - Inhalation devices

Expired
  • Salary: Negotiable
  • Job type: Permanent
  • Location: Leinster
  • Sector: Science
  • Date posted: 18/01/2018
  • Job reference: J380203A

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Analytical Team Lead - Inhalation devices

About the Associate Group Leader position

My clients lab employees are committed to quality results and strict compliance with regulatory standards. The role of Team lead is to provide support to my clients Inhalation Technology Services department by providing management and direction to laboratory staff and resources for project activities and needs, overseeing daily operations to monitor quality and project timeliness, and assist in preparation and implementation of company policies, quality systems and training programs. You will have ownership to ensure responsiveness to the client and overall client satisfaction. This position is lab based, with direct supervisory responsibilities of a small group of Scientists.


Key responsibilities:

  • Management of a team of analysts
  • Allocation, scheduling and managing laboratory resources for group's project activities and updates LIMS for project status. Reviews timesheet reports for billing accuracy.
  • Preparation, review and approval of study protocols, project status reports, final study reports and other project-related technical documents.
  • Designing experimental study and participates in technical troubleshooting.
  • Reviewing data for technical quality and compliance to protocols, methods and SOPs. Review and approve laboratory investigations, deviations, QA facility and data audits. Assists in client and regulatory authority audits.
  • Responding to client questions and needs; leads client technical meetings.
  • Assisting in preparation of proposals, project definition and pricing.
  • Coordinating and prioritizing project activities with internal functional groups (physical testing, analytical development, microbiology, etc.) and support functions (QA, sample management, etc.)
  • Assisting senior group leaders and/or managers in their responsibilities.
  • Preparation and implementing SOPs and company operational policies. Ensuring adherence and making recommendations to quality system improvements.

Qualifications

Skills and experience:

  • Educated to a Bachelor's Degree level in a relevant area, ie chemistry.
  • Management experience in the pharmaceutical, biotech or analytical contract laboratory industries.
  • Stability/QC/analytical R&D/project and program management.
  • Direct supervision of technical staff.
  • Full understanding of GMP requirements, client SOPs, ICH guidelines, EP and USP requirements and EMEA and FDA guidance's.
  • Knowledge and experience with inhalation products such as Pressurised Metered Dose Inhalers, (pMDI), Dry Powder Inhalers (DPI), Aqueous Nasal Sprays, Nebulisers and Nebuliser solutions.

Contact Kathryn on or call 01 6455244/0873555378 for aditional information about this or other new opportunities.