Collins McNicholas

Job Purpose:
The Process Chemist is responsible for the introduction and scale-up of chemistry processes to R&D, Pilot Plant, Cork for the production of drug substance primarily for use in clinical, toxicology and safety trials. He/she is also responsible for the commercial evaluation of processes with a view to identifying scale-up issues e.g., cost of goods, cycle time, crystallization.

Role Responsibilities:

  • Campaign Coordinator for the introduction of new projects to the Cork Plant.
  • Technical evaluation of processes with respect to chemistry, safety, plant fit, materials hazards, etc.
  • Coordinate activities with local and off-site teams including: Synthetic Chemistry, Engineering, Analytical, EHS, Logistics, Quality, Procurement & (Manufacturing Enterprise Resource Planning System) MERPS to deliver the project.
  • Working closely with the materials coordinator to manage all materials aspects of the project.
  • Draft key project supporting documentation including, solvent batch, master batch record, cleaning limits and equipment decontamination, ensuring all process related technical, safety and quality requirements are met.
  • Development and roll out of process training packs to operations staff.
  • Technical support of the campaign while running on plant and coordination of cleaning activities post production.
  • Quality review of completed plant documentation and support/investigation of process related deviations
  • Deliver projects on time & in full and compliantly with respect to safety & quality.
  • Troubleshooting processes at plant scale.
  • Completion of post campaign report / AAR.
  • Identify areas for process development, scale-up & optimization working with the synthetic chemistry team to implement these improvements over successive campaigns with a view towards commercialization.
  • Input into the QbD (Quality by Design) process through the project lifecycle.
  • Liaising with the NPI (New Product Introduction) CoE (Centre of Excellence) leads / PD (Product Development) Project leads and GMS (Global Manufacturing 7 Supply) to ensure key manufacturing requirements are designed into the process.
  • Technical transfer of the processes to commercial
  • Campaign Coordinator for commercial GMS campaigns run in the Cork Plant as required.
  • Ensure visiting chemists training is completed prior to their interfacing with the laboratory or plant.
  • Carry out (or support visiting chemist in carrying out) any laboratory work required in support of the project, ensuring adherence to laboratory ways of working.

 

Role Requirements:

  • PhD in Synthetic Organic Chemistry or a good B.Sc. Hons. Ideally with 3-5 years relevant experience in pharma industry
  • Have a sound technical knowledge of their specific discipline and good understanding of critical business functions on site.
  • Detailed knowledge of the cGMP requirements relevant to the role
  • Ability to identify and implement process improvements without impacting safety or quality
  • Good technical knowledge of chemistry, scale-up & safety
  • Excellent communication, interpersonal, facilitation and presentation skills
  • Strong working knowledge of Lean sigma principles

For a confidential discussion and more information on the role, please contact Rory Walsh on 021-4911063 or email rory.walsh@collinsmcnicholas.ie

 

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