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Formulation Development Director

2 weeks ago


The Municipal District of Baltinglass, Ireland MCS Group Consultancy Full time

Drive innovation in the pharmaceutical manufacturing industry as a key leader at MCS Group Consultancy. As the Head of Formulations - Pharmaceutical Development, you will oversee the R&D Pharmaceutical Development Formulations team in the development, scale-up, and characterization of new product formulations.

Key Responsibilities:

  • Lead the formulations team, guiding formulation strategy and overseeing new product introductions.
  • Develop chemical and physical analytic methods for early-stage product development.
  • Implement the Quality by Design (QbD) approach, identifying Critical Material Attributes (CMAs) and Critical Process Parameters (CPPs) to develop robust, scalable manufacturing processes.
  • Oversee reverse engineering of commercial reference products.
  • Manage the manufacture of products for clinical evaluations, ensuring timely delivery of test articles.
  • Lead risk analysis for tech transfers related to formulations, manufacturing processes, and analytical methods.
  • Ensure optimal resource use through capacity analysis and track key performance indicators to deliver projects on time.
  • Support CMC regulatory dossier preparation and review for regulatory submissions.
Required Skills and Qualifications
  • PhD in Pharmacy, Chemistry, or Pharmaceutical Sciences.
  • 10+ years in pharmaceutical product development or manufacturing, with 5+ years managing large teams.
  • Strong leadership, project management, and cross-functional collaboration skills.
  • In-depth understanding of challenges and technologies in formulation and process development across dosage forms.

Benefits

  • Competitive salary.
  • Subsidised canteen.
  • Discount on car insurance.
  • Enhanced annual leave.
  • Life assurance.
  • Company pension scheme.
  • Healthcare cash plan.
  • Development and growth opportunities.