Job Title: Formulation Scientist â 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.
