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BioPharmaceuticals Team Lead

Expired
  • Salary: Negotiable
  • Job type: Permanent
  • Location: Westmeath
  • Sector: Science
  • Date posted: 27/08/2018
  • Job reference: BBBH13774

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BioPharmaceuticals Team Lead

My clients GMP laboratory offers fully integrated solutions for product development and analytical development, including analytical testing services in method development and secondary packaging, labelling and storage. Thier highly qualified GMP lab staff work with large and small molecules, including active pharmaceutical ingredients (API), drug products, inhaled products and other medical devices.

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

  • 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 of a wide range of techniques, HPLC, UPLC, Electrophoresis (CE, iCE, SDS-PAGE), ELISA, spectrophotometry.

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

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