Process Scientist

1 week ago

Dublin, Dublin City, Ireland Actalent Full time

Process Scientist: Technical Operations will be responsible to perform and oversee multi-step process development, standardisation, and evaluation with an aim of establishing laboratory scale manufacturing modules to solve complex issues related to materials and process related changes. Working within the Technical Operations team, Process Scientist will also support the production activities ongoing in the existing manufacturing facility and will have considerable development laboratory focus for replication of the process at small scale. The Process Scientist will collaborate closely with other functions, including Operations, Quality (QA/QC), regulatory and other internal and external stakeholders.

Responsibilities:

  • Develop and maintain laboratory scale manufacturing models to attain a deeper understanding of the process and implement process control strategy in the commercial manufacturing environment.
  • Utilize all chemistry and laboratory tools and techniques (i.e. FTIR, NMR, UPLC/MS, Lyophilisation, Autoclave, extraction and purification etc.) to develop, assess and improve the manufacturing process and pathways.
  • Carry out feasibility study of the Process, Process Optimization, Lab Validations, Technology Transfer to plant and identify and evaluate the process parameters.
  • Assist in the design, planning and execution of multi-step experimental studies guided by risk assessment to deliver safe, efficient, robust and scalable manufacturing processes.
  • Investigate optimization and scale-up of reaction and manufacturing unit operations.
  • Collaborate within project teams by working closely with analytical chemists, process engineers, pilot plant experts and project managers within the organization.
  • Communicate scientific results in a clear, concise, and accurate manner via electronic laboratory notebook documentation, development reports, project discussions and presentations.
  • Draft and review technical reports, external publications and patent applications.
  • May include management of outsourced laboratory activities: generating scope of work, supervising activities at CMOs, validating reports for outsourced activities.
  • Leads Tech Transfer projects between CMOs and internal stakeholders.
  • Authors or provides technical review of project documents, validation protocols, batch records, etc.
Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Manufacturing and Science

Industries

Pharmaceutical Manufacturing

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