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Formulation Scientist Career Profile

Formulation Scientist

A formulation role is one of the more theoretical and "scientific" roles on the market, drawing on many of the theories students would have learned in college. This role concerns the development of various release forms of medicines on the macro level. On a micro level, there will be tasking like testing different excipients, capsules, coating etc. to see which works best. Although not many roles of this type n Ireland, we often require experience formulators for our existing and new Clients.

Key Activities of the Formulation Scientist

  • Development of parenteral formulations and analytical methods for in-process testing.
  • Conduct and lead pre-formulation and formulation activities of in-house new developed products and line extensions.
  • Perform method validation/qualification for in-process testing.
  • Perform, track and monitor stability testing as required.
  • Draft batch records, supervise the manufacture of Exhibit batches and assist on the transfer of processes to Production.
  • Ensure timely new product introduction in accordance with cGMP and ISO standards.
  • To prepare, review and take responsibility on advanced area documentation (Laboratory notebooks, reagent logbooks, SOPs, Exhibit batch records, Protocols, Reports and Specification sheets).
  • Check formulation activities from other Formulation Scientists and supervise their training.
  • Lead critical Investigations, problems and develop solutions in more unusual situations.
  • Recommend modifications to processes and understand the impact of these modifications on the broader research area.
  • Attend and lead internal-external meetings with other Departments, organizations and CRO with the aim to fast-track Project development.
  • Participate and consult with the internal and external scientific community to maintain a state-of-the-art knowledge for application to successful conduct of experiments and projects.
  • Ensure equipment is adequately qualified and maintained in accordance with cGMP requirements.
  • Maintain laboratory SOPs in a state of compliance.
  • Elaborate documentation for product registration.