Collins McNicholas


QC Bioassay Team Leader


Global Biologics Company




  • Be able to work in accordance with GMP practices, conducting all activities in a compliant manner.
  • Willing to take on additional activities with little to no supervision
  • Contribute to continuous improvement of procedures and processes at the company.




Responsible for the following testing, as and when required:

  • ELISA based assays
  • Ligand binding assays
  • Cell based assays
  • Preparing working cell banks using tissue culture techniques
  • Microscopy work
  • Aseptic practices


Responsible for performing the following activities:

  • Communicating business critical Information to the line manager
  • Play a role in the day to day management of the Quality Control department
  • Help establish and maintain departmental metrics
  • Lead Technology Transfers / Validations
  • Review and approve, where required, generated technical documentation
  • Initiating deviations, leading level 2 deviations, and supporting staff involved in level 2 and 3 deviations
  • Raising and leading OOS/OOT investigations
  • Scheduling of daily activities within the department
  • Ensuring completion of daily work activities
  • Perform routine 1: Ts with direct reports
  • Assist with objective setting and tracking
  • Provide oversight and technical guidance to ensure the right level of scientific ability within the department
  • Review of laboratory documentation including testing paperwork
  • Ensure that master laboratory records are completed to the required standards
  • Identifying required document changes and empowering staff to ensure changes are implemented in a timely fashion
  • Identify and lead change control direct or through others
  • Work with fellow Team Leaders within Quality Control on departmental initiatives
  • support facility tours
  • Ensure maintenance of regulatory readiness and active participation in regulatory preparation and inspections
  • Be aware of and comply with the company current EHS policies
  • Participate in training of staff

Additional Skills:

  • Communication Skills: Excellent written and verbal communication skills
  • Linguistic Skills: Fluent command of the English language, both written and verbal
  • Computer Literacy: Proficient in use of a PC and common Microsoft packages such as Word, Visio, Excel
  • Organisation and Management Skills: Will be required to participate and make positive

contribution to team meetings. Responsible for individual performance management.

  • GMP Experience: Will be expected to work to and comply with the requirements of the company QMS cGMP and Good documentation practises and policies. Will participate in self inspections and regulatory inspections



  • Education: Minimum of a MSc in a relevant scientific discipline and direct industry experience or 5 years’ experience in Pharmaceutical or Biopharmaceutical sector.
  • Experience: Knowledge and proven experience of working to GMP standards. Two years people management experience

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