Formulation Scientist Inhalation Product

Job Description

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:

• Bachelor’s or Master’s 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.