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Team Lead Bioassay

  • Location:

    Poland

  • Contact:

    Noreen Daly

  • Job type:

    Contract

  • Contact phone:

    +353 21 485 7281

  • Industry:

    Biotechnology

  • Contact email:

    noreen_daly@oxfordcorp.com

Job Description

This consultant will be expected to oversee the work of 10 analysts/scientists with the majority of these being late twenties/early thirties in age so quite a young team. The Client would like to see at least 2-3 years supervision experience and between 7-10 years' experience in total.

Responsibilities

  • QC Bioassays Team management, motivating employees towards achieving of the set objectives
  • Approval of specifications, sampling instructions, test methods and other biological procedures in Quality Control department
  • Preparation, review and approval of protocols, reports, methods, procedures, instructions and other Quality Control documents
  • Ensuring the performance of all necessary biological analysis and evaluation of records
  • Timely and reliable performance of analyses
  • Responsibility for Certificates of Analyses
  • Ensuring performance of appropriate validation of pharmacopeial methods
  • Ensuring maintenance and qualification of premises and equipment in the department
  • Providing introductory and other trainings according to employees' needs
  • Participation in internal and external audits
  • Performing all the duties according to current GMP requirements and other pharmaceutical regulations
  • Selection of and cooperation with contract laboratories
  • Supervision of the quality records
  • Preparation of the annual budget of Quality Control Bioassay based on production plans
  • Planning of subordinate employees' work and progress reporting

Requirements

  • ELISA/QPCR/Cell Based Assays
  • GMP
  • QC experience
  • QC Supervision/Team Lead experience/Manager
  • Method Transfer
  • Method Validation
  • Bio Method experience
  • Stability
  • Motivator/Teacher/Hands on/driver/approachable