Head of Formulations

2 days ago

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

Are you ready to take the next step in your career and become part of a high-growth global pharmaceutical manufacturing company, that's driving innovation?

MCS Group is proud to be partnered with our client who is looking for a Head of Formulations - Pharmaceutical Development.

As the Head of Formulations - Pharmaceutical Development, you will lead the R&D Pharmaceutical Development Formulations team in the development, scale-up, and characterization of new product formulations.

Key Responsibilities:
  1. Lead the formulations team, overseeing new product introductions and guiding formulation strategy.
  2. Develop chemical and physical analytic methods for early-stage product development.
  3. Implement the Quality by Design (QbD) approach, identifying Critical Material Attributes (CMAs) and Critical Process Parameters (CPPs) to develop robust, scalable manufacturing processes.
  4. Oversee reverse engineering of commercial reference products.
  5. Manage the manufacture of products for clinical evaluations, ensuring timely delivery of test articles.
  6. Lead risk analysis for tech transfers related to formulations, manufacturing processes, and analytical methods.
  7. Ensure optimal resource use through capacity analysis and track key performance indicators to deliver projects on time and on budget.
  8. Support CMC regulatory dossier preparation and review for regulatory submissions.
Technical Expertise Needed:
  1. Extensive experience in dosage form development for orals and injectables.
  2. Strong knowledge of chemical and physical analytic methods required for formulation development and product approval.
  3. Proven track record in formulation process development and tech transfer to manufacturing operations.
  4. Understanding of Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP), with the ability to implement and maintain compliance.
  5. Familiarity with industry standards like USP, Ph Eur, and ICH guidelines.
  6. Experience with in-vitro method development and demonstrated understanding of in-vitro/in-vivo correlations is a plus.
  7. Knowledge of AI applications in formulation development would be advantageous.
About You:
  1. PhD in Pharmacy, Chemistry, or Pharmaceutical Sciences.
  2. 10+ years in pharmaceutical product development or manufacturing, with 5+ years managing large teams.
  3. Strong leadership, project management, and cross-functional collaboration skills.
  4. In-depth understanding of challenges and technologies in formulation and process development across dosage forms.
What's in it for you?
  1. Competitive salary (DOE)
  2. Subsidised Canteen
  3. Discount on car insurance
  4. Enhanced Annual Leave
  5. Life Assurance
  6. Company Pension Scheme
  7. Health care Cash Plan
  8. Development and growth opportunities
  9. On-site free car parking... and many more benefits. Full details will be provided upon application.

To speak in absolute confidence about this opportunity please send an up-to-date CV via the link provided or contact Amy Wallace, Specialist Consultant at MCS Group.

Even if this position is not right for you, we may have others that are. Please visit MCS Group to view a wide selection of our current jobs.

All conversations will be treated in the strictest of confidence.

Not all agencies are the same… MCS Group are passionate about providing a first-class service to all our customers and have an independent review rating of 4.9 stars on Google.

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