Collins McNicholas

Role Responsibilities:

  • Effectively coordinating and managing team members so that productivity, quality, documentation, work schedules, safety and housekeeping is run at maximum efficiency.
  • Responsible for ensuring that the client gets the best possible service by continually reviewing best practice in relation to both commercial and quality issues and ensuring 100% ethical work standards and GMP compliance.
  • Responsible for the development, coaching, motivation, and morale of team members through effective teambuilding and use of reward and recognitions systems celebrating team success.
  • Responsible for reviewing and approving all relevant documentation and technical data in a timely manner and ensuring that it communicated, documented, and filed accurately.
  • Responsible for ensuring that work is scheduled, and cross training takes place so that the service levels agreed with the customer are achieved. Responsible for amending schedules as required.
  • Ensure that all analysts are trained and have completed training records for all activities and other training completed.
  • Responsible for carrying out performance appraisals with staff as part of the overall performance management programme within the organisation.
  • Responsible for continuous feedback to all members of their team on all items in relation to client or organisational requirements / changes.
  • Responsible for handling any customer related queries where necessary and liaising with their team and with personnel from other teams to problem solve these queries if needed.
  • Perform investigations, where required, for API Large Molecule Lab issues etc.
  • Perform other duties as designated by Laboratory Management.
  • Support early and late phase Technical Transfer activities through generation of protocols/reports, technical writing, execution of laboratory scale studies and participation in manufacturing operations and NPI initiatives.
  • Supporting early and late phase product development activities through generation of protocols/reports, execution of laboratory scale studies and participation in Lean Early Development initiatives as required.
  • Providing expertise to development teams on manufacturing facility design and capabilities, scale-up considerations and GMP operations. Partner with Project Teams to provide input, review and approval support for BLA submissions.
  • To interpret project plans and timelines for CMC projects and schedule work and experiments to meet these goals.
  • To assist in manufacturing investigations as required, in particular event, deviations and CAPAs, to help meet product release specifications and timelines.
  • To execute experimental plans and protocols to support product life-cycle improvements, process validation requirements, technical transfer projects and development activities as required.
  • To foster a culture of Lean and Continuous improvement within the department and with internal and external partners.

 

Role Requirements:

  • A Bachelors’ Degree or Masters’ Qualification or PhD Qualification in Biotechnology, Biopharmaceutical sciences or relevant biological or life science is required.
  • At least 5 years of GMP industry experience
  • Excellent leadership skills and at least 3 years’ previous supervisory experience.
  • Analytical skills to troubleshoot laboratory issues are an asset.
  • Ability to quickly learn new processes.
  • Experience in aseptic techniques is required.
  • Ability to communicate clearly and to form strong working relationships with colleagues.
  • Willing to operate in a flexible manner and be able to switch priorities at short notice.
  • Organised, accurate, have strong documentation skills.
  • Passionate about quality and customer service.
  • Good communication skills both internally and externally.
  • Excellent attention to detail
  • Good communicator – easily communicate findings and recommendations to internal clients.

For a confidential discussion and more information on the role, please contact Aisling Lane on 021-4809118 or email aisling.lane@collinsmcnicholas.ie

 

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