Senior Pharmaceutical Development Manager

4 weeks ago

Newry, United Kingdom SEDA Talent Full time

The Client

Seda Talent is supporting a global pharmaceutical manufacturer in recruiting a Senior Pharmaceutical Development Manager to join their senior leadership team.

The Role

This is a strategic leadership position that will provide oversight to the formulation teams in the support of new product introduction. The successful candidate will be responsible for the assessment of all new candidates for new product development, including the provision of costings for the conduct of all associated work.

Key Responsibilities:

  1. Development of chemical and physical analytical methods to support early stage product development
  2. Support and implement the QbD approach to Pharmaceutical Development
  3. Identification and evaluation of product Critical Material Attributes (CMAs)
  4. Identification and evaluation of Critical Process Parameter (CPPs)
  5. Development of robust, scalable Manufacturing Processes
  6. Reverse engineering of commercial reference products
  7. Manage manufacture of products for clinical evaluations and ensure on time delivery of test articles
  8. Drive risk analysis in support of the Tech Transfer process within the Pharmaceutical Department regarding formulations, manufacturing processes, and formulations analytical methods
  9. Support the introduction and maintenance of key performance indicators within Pharmaceutical Development – Formulations delivering projects on time and on budget
  10. Drive capacity analysis within the Pharmaceutical Development Formulations teams to ensure optimal and efficient use of resources and equipment
  11. Work closely with other R&D Management Team members to ensure project goals are met to the right quality, cost, and on time
  12. Play a key role representing Chemistry, Manufacturing, and Control on Project Teams
  13. Support the compilation of budgets for the Pharmaceutical Development Formulations teams and ensure continual review of actual spend vs budget
  14. Support compilation and review of CMC sections of regulatory dossiers and provide technical input to regulatory queries as required
  15. Ensure all work undertaken within the group complies with current guidance (USP, Ph Eur, (V)ICH), and industry best practice
  16. Oversee Formulations manufacturing and formulations analytical Laboratories and ensure they are kept in a state of audit readiness at all times

Requirements:

  1. Educated to at least PhD level in Pharmacy, Chemistry or Pharmaceutical Sciences
  2. A minimum of 10 years relevant experience within the pharmaceutical industry, specifically in pharmaceutical product development or a process/manufacturing environment
  3. At least 5 years' experience managing a large team of people encompassing formulation and analytical capability
  4. An excellent understanding of technologies (and challenges) associated with formulation and process development over a range of dosage forms
  5. Competent in chemical and physical analytical methodology and testing procedures necessary for the development and approval of successful formulations
  6. Technical expert in dosage form development of orals and injectables
  7. Extensive proven knowledge of requirements associated with technical transfers to Manufacturing Operations
  8. Experience of working to current Good Manufacturing Practice and/or Good Laboratory Practice and implementing policies and procedures in line with regulatory guidelines

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