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BioPharmaceuticals Team Lead

Expired
  • Salary: Negotiable
  • Job type: Permanent
  • Location: Westmeath
  • Sector: Science
  • Date posted: 26/02/2018
  • Job reference: J380207A

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BioPharmaceuticals Team Lead

Job Description:

The role of Biopharmaceuticals Team Lead is to provide support to the BioPharm 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. The Team Lead will have ownership to ensure responsiveness to the client and overall client satisfaction.

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.

Skills/Responsibilities:

  • 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 guidelines
  • Knowledge and experience of a wide range of techniques, HPLC, UPLC, Electrophoresis (CE, iCE, SDS-PAGE), ELISA, spectrophotometry

Contact Kathryn on kathryn.whyte at experis.ie or call 01 6455244/0873555378 for additional information about this or other new opportunities.