Formulation Scientist

Job Title: Formulation Scientist Inhalation Product Development

Department: Product Development

Permanent Based in Co Tipperary

About the Role:
Our Client is seeking a Formulation Scientist to join their Inhalation Product Development team. This role is ideal for someone with a passion for hands-on pharmaceutical formulation development particularly in lab-scale and scale-up batches execution. You will take full ownership of batch manufacturing activities assist in the execution of exhibit/submission batches and play a key role in defining robust and scalable processes for commercial manufacturing of Metered Dose Inhalers (MDIs) and Dry Powder Inhalers (DPIs).

Key Responsibilities:

• Execute lab-scale and scale-up batches with full ownership ensuring accuracy compliance and documentation.
  
• Assist in the manufacture of exhibit batches for stability clinical or regulatory submission purposes.
  
• Support the definition and optimization of manufacturing processes suitable for commercial scale ensuring reproducibility and regulatory compliance.
  
• Collaborate closely with the lead formulator to align on experimental designs process development activities and technical goals.
  
• Generate analyze and interpret data using sound scientific principles and appropriate statistical tools.
  
• Prepare experimental protocols maintain detailed and timely records of all development work and contribute to development reports and technical documentation.
  
• Support preparation of batch records protocols reports material specifications and other CMC-related documentation. Contribute to writing sections of regulatory dossiers.
  
• Participate in practical problem-solving related to formulation or process challenges during development or scale-up.
  
• Apply GMP principles Standard Operating Procedures (SOPs) and company policies during all phases of work.
  
• Understand and apply Quality by Design (QbD) principles in the formulation and process development lifecycle.
  

Requirements

Qualifications & Experience:

• Bachelors or Masters degree in Pharmaceutical Sciences Chemistry Chemical Engineering or a related field.
  
• At least 3 years of relevant experience in formulation development for pharmaceutical biotechnology or combination drug products is essential.
  
• Practical experience in formulation process development or technology transfer is a required qualification.
  
• Experience with inhalation products (MDI/DPI) is desirable but not essential.
  
• Strong data analysis reporting and documentation skills.
  
• Proactive self-motivated and capable of working both independently and as part of a cross-functional team.
  
• Able to adapt to changing priorities and work in a fast-paced environment.