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.