Head Of Pharmaceutical Development, Formulations
NorbrookNewry, Down
- To provide strategic leadership to the Formulation’s teams in the support of new product introduction
- To act as primary contact for assessment of all new candidates for new product development including provision of costings for the conduct of all associated work
- Development of chemical and physical analytical methods to support early stage product development
- To support and implement the QbD approach to Pharmaceutical Development
- Identification and evaluation of product Critical Material Attributes (CMAs)
- Identification and evaluation of Critical Process Parameter (CPPs)
- Development of robust, scalable Manufacturing Processes
- Reverse engineering of commercial reference products
- Manage manufacture of products for clinical evaluations and ensure on time delivery of test articles
- To drive risk analysis in support of the Tech Transfer process within the Pharmaceutical Department in regard to formulations, manufacturing processes and formulations analytical methods
- Support the introduction and maintenance of key performance indicators within Pharmaceutical Development – Formulations delivering projects on time and on budget
- Drive capacity analysis within the Pharmaceutical Development Formulations teams to ensure optimal and efficient use of resources and equipment
- Work closely with other R&D Management Team members to ensure project goals are met to the right quality, cost and on time.
- Play a key role representing Chemistry, Manufacturing and Control on Project Teams.
- Support the compilation of budgets for the Pharmaceutical Development Formulations teams and to ensure continual review of actual spend vs budget
- Support compilation and review of CMC sections of regulatory dossiers and where required provide technical input to regulatory queries.
- Ensure all work undertaken within the group complies to current guidance (USP, Ph Eur, (V)ICH), and industry best practice.
- Oversee Formulations manufacturing and formulations analytical Laboratories and ensure they are kept in a state of audit readiness at all times
- Maintain an awareness of current trends and developing technologies in the manufacture of pharmaceutical dosage forms and analytical methods
- Provide required governance ensuring resources are accurately logged within the Timesheet system.
- Any other duties as deemed necessary by Management.
- Educated to at least PhD level in Pharmacy, Chemistry or Pharmaceutical Sciences
- A minimum of 10 years relevant experience within the pharmaceutical industry. Specific experience working within pharmaceutical product development or a process/manufacturing environment.
- At least 5 years’ experience managing a large team of people encompassing formulation and analytical capability
- An excellent understanding of technologies (and challenges) associated with formulation and process development over a range of dosage forms
- Competent in chemical and physical analytical methodology and testing procedures necessary for the development and approval of successful formulations
- Technical expert in dosage form development of orals and injectables
- Extensive proven knowledge of requirements associated with technical transfers to Manufacturing Operations.
- Experience of working to current Good Manufacturing Practice and/or Good Laboratory Practice and implementing policies and procedures in line with regulatory guidelines.
- Knowledge, understanding and/or application of AI within formulation development.
- Experience in in-vitro method development to demonstrate in-vitro/in-vivo correlations
- A minimum of 15 years relevant experience within the pharmaceutical industry.
- Fully conversant in EU and US regulatory landscape .
The closing date for applications is Friday the 25th of October 2024
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