Collins McNicholas

Role Responsibilities:

  • Collaborate closely with the Material Science group and guide pharmaceutical development teams on the selection of materials based on scientific, quality and regulatory criteria.
  • Collaborate with raw material suppliers within Ireland and Europe to establish effective control strategies based on understanding and importance of raw material in API manufacturing
  • Contribute towards developing raw material specifications, e.g., cell culture media, chromatography resins and excipients
  • Perform Bill of Materials Assessment for new materials introduced to the site and source alternative vendors and suppliers when needed
  • Support Analytical method transfers by coordinating testing with Europe based Analytical labs
  • Review and implement industry and regulatory requirements for raw materials, e.g., ICH guidance
  • Support raw material investigations and life cycle activities related to raw materials including leading and/or participating in root cause analyses
  • Support supplier audits as required
  • Identify and coordinate analytical characterisation with the internal and external labs and perform testing as applicable
  • Actively participate on cross-functional R&D and manufacturing teams to advance projects goals and deliverables related to raw materials
  • Participate in project and scientific meetings to share information, knowledge, ideas, and judgement to help establish valid scientific directions in product development or investigations
  • Ensure compliance with safety, GMP, quality and scientific principles
  • Develop subject matter expertise on assigned analytical techniques.
  • Independently write/revise SOP’s or other official documentation and technical reports, when required.
  • Execute independently assigned projects.
  • Train/Coach other personnel.

 

Role Requirements:

  • A BSc in a Science subject, Materials Science, Chemistry, Engineering or a related field, with at least 9 years of experience or a MSc in in a Science subject, Materials Science, Chemistry, Engineering or a related field with at least 6 years of experience or Ph.D. with at least 2 years of post-doctoral experience is essential
  • Proficiency in functional characterisation of cell culture media including cell culture performance evaluation using stationary, shake flask, automated cell culture systems, and/or bioreactors is required
  • Demonstrated proficiency in the analytical characterization of cell culture media and materials utilized in upstream processes and downstream processes is preferred
  • Experience in qualification of cell culture media and raw materials is strongly preferred
  • Demonstrated competency and experience in development and management of raw materials specifications including compendia testing is an advantage
  • Demonstrated competency and experience in use of project management and database tools (e.g., MS Project)
  • Microsoft office proficiency in Excel, Word, PowerPoint are required
  • Experience with lean and/or six sigma methodologies and tools is preferred
  • Ability to quickly learn new processes.
  • 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.

 

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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