Job Description
Senior Analytical Development & Transfer Chemist role involves leading analytical activities, managing projects, and supervising a team to ensure timely delivery of R&D activities.
Eirgen Pharma, a growing and innovative company, develops and supplies specialty care medicines to patients worldwide. Our guiding principle is to improve and enhance patient lives across the globe.
The company's Waterford campus features a state-of-the-art manufacturing environment with tableting, capsule, soft gel manufacturing, and packaging capabilities. Our R&D function accommodates development and analytical scientists working on the next generation of treatments.
You will be responsible for:
- Leading development, validation, transfer, verification, and stability studies as required.
- Project managing analytical elements of new product introductions, ensuring adherence to NPI deliverables.
- Supervising the analytical team and running daily lab meetings.
- Being the technical point of contact for analysts in the lab and dealing with day-to-day issues.
- Drafting and reviewing test methods, validation/verification/transfer protocols, and reports as applicable.
- Representing Analytical R&D at internal and customer meetings.
- Liaising directly with contract laboratories as required.
- Deputising for the Analytical Development & Transfer Manager as required.
- Assisting/leading 5S/H&S/GMP inspections in the laboratory as required.
- Participating in/laboratory investigations as required.
- Generating and completing Trackwise records as required.
- Analysing raw materials, in-process samples, and finished products to ensure quality and efficacy.
- Assisting in preparation for customer/regulatory inspections.
- Preparing submission documentation in support of license applications.
- Identifying and making recommendations for improvements to ensure continuous improvement.
- Ensuring all work is in compliance with required standards, cGxP, SOPs, regulatory regulations, and guidelines.
- Completing documentation correctly, in line with data integrity guidelines.
- Peer reviewing documentation as required.
- Performing additional team tasks as agreed to support effective running of the Business.
- Supporting all other ongoing laboratory functions and requirements.
Health and Safety responsibilities include:
- Ensuring the requirements of Eirgen's Safety Statement are implemented.
- Continuously promoting a positive safety culture by leading by example.
- Implementing safety requirements as per site documentation.
- Reporting any defects/hazards as they arise.
At Eirgen, we have developed a diverse, people-centric, high-performance culture where people are enabled to achieve their potential. Our employees are high-performing and work as part of a cohesive team, dedicated to succeeding and rewarded with competitive salaries and attractive benefits.
To be considered for this role, please send your CV to opportunities@eirgen.com including the job title in the subject.