Collins McNicholas

The successful Analytical Laboratory Lead will be responsible for the planning, coordination and management of all activities in the Laboratory. This position is responsible for ensuring the effective implementation and compliance with policies, procedures and practices.

Analytical Laboratory Lead Key Responsibilities:

  • Test method development, validation and technical transfer as required. 
  • To assist in the generation of all relevant laboratory standard operating procedures. 
  • To carry out raw material, in process, development, finished product and stability testing as required. 
  • To maintain all laboratory notebooks, test sheets, specifications, records, chromatograms and documentation to an acceptable GLP standard. 
  • To maintain good housekeeping and hygiene within the laboratory. 
  • Initiation, coordination and completion of laboratory investigations, deviations and change controls 
  • To calibrate and maintain designated laboratory instruments. Assist with monitoring of the Equipment Calibration Schedule and being the point of contact for equipment breakdown and maintenance as requested.
  • To support the laboratory testing schedule in order to achieve an efficient system. To liaise between laboratory analysts and manager on all issues relating to raw materials, in process, finished product, and stability testing. 
  • To alert management to any discrepancies, deviations or non-conformances in testing or work practice. 
  • To follow up-to-date analytical practices with reference to specifications, regulations and industry standards. 
  • Trending of data as requested. 
  • To adhere to any agreed internal laboratory rota tasks. 
  • To liaise with other departments in relation to testing requirements as necessary. 
  • To liaise with external suppliers/vendors, raising purchase orders, chemical/reference standard COAs and MSDS as necessary. 
  • Staff Training and development.
  • Perform and assist with additional duties as requested.

Knowledge, Skills, and Abilities required:

  • BSc/MSc in science discipline required
  • At least 3 years in a pharmaceutical QC laboratory 
  • At least 2 years HPLC, dissolution and raw material (EP/USP) testing experience 
  • cGMP/GLP
  • Required subject matter expertise in analytical method development, validation, and transfer.
  • Participated in regulatory audits.
  • Comfortable liaising with external vendors.
  • Demonstrated ability to inspire high performance in others and align team members around shared goals.
  • Recognise areas for improvement, and use initiative to implement programs in support of progress.
  • Ability to deliver objectives in line with project plans.
  • Highly flexible, works well in a team and has necessary skills to organise, communicate, influence and lead.
  • Travel to Europe and international occasionally.

 

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