Collins McNicholas

The role of Associate Group Leader is to provide support to our BioPharm department by providing management and direction to a group of 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. 

Key responsibilities:

  • Management of a team of analysts
  • Allocation, scheduling and managing laboratory resources for group’s project activities.
  • Preparation, review and approval of study protocols, project status reports, final study reports and other project-related technical documents.
  • Designing an 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, 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.

 Analytical Group Supervisor skills and experience:

  • Educated to a Bachelor’s Degree level in a relevant area, ie chemistry, biochemistry
  • Supervisory 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.
  • Knowledge and experience of a wide range of techniques, HPLC, UPLC, Electrophoresis (CE, iCE, SDS-PAGE), ELISA, spectrophotometry.

This role offers an excellent opportunity for someone who has previous GMP experience in a small molecule environment coupled with proven record of team leadership; who would now like to embrace a new technical environment/Biopharm specific techniques.

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