Job Description
Senior Analytical Development & Transfer Chemist
Reach your career goals with Eirgen Pharma, your future could be here
Would you like to be part of a company that has the courage, innovation, and capability to improve and enhance patient lives across the globe?
A growing and innovative company based in Waterford, Eirgen Pharma develops and supplies specialty care medicines to patients in more than 50 countries worldwide. Our guiding principle is to improve and enhance the lives of patients, whether they be reached directly or through our contract manufacturing and development customers across the pharmaceutical industry.
Eirgen's Waterford campus consists of a state-of-the-art and globally-accredited manufacturing environment which provides tableting, capsule, soft gel manufacturing and packaging capabilities. Our R&D function accommodates our development and analytical scientists working on the next generation of treatments for the company and its clients.
About you
You are qualified to a minimum of degree level in Analytical Chemistry/Pharmaceutical Science or a related discipline and have at least five years' experience working in a related technical environment.
You are competent in a range of analytical methods (HPLC/Dissolution), with excellent knowledge of GMP and good project management skills. You have working knowledge of Empower lab software & electronic document management systems, possess excellent written & verbal communication skills, with a broad understanding of regulatory requirements for submission of dossiers in EU, USA, Japan and other jurisdictions.
You will draw from your many skills such as adaptability, planning, multi-tasking and time management. You have the ability to form positive relationships and enjoy collaborating, gaining knowledge, continuous improvement and solving problems.
About the Job
In this role you will support Product Development and Clinical Supply and work with the Analytical Development & Transfer Manager to ensure that all R&D Analytical activities are achieved in a timely fashion.
You will:
- Lead in development/validation/transfer/verification/stability studies as required.
- Project manage Analytical elements of New Product introductions to Eirgen, ensuring adherence to NPI deliverables. Act as point of contact for customers associated to Analytical elements of NPI projects.
- Supervise the analytical team and run the daily lab meetings.
- Be the technical point of contact for analysts in the lab and deal with any day to day issues.
- Draft/review test methods, validation/verification/transfer protocols and reports as applicable. Perform technical review of documentation on behalf of the team lead as required.
- Represent Analytical R&D at internal & customer meetings.
- Liaise directly with contract laboratories as required.
- Deputise for Analytical Development & Transfer Manager as required.
- Assist/lead 5s/H&S/GMP inspections in the laboratory as required.
- Take part in/complete laboratory investigations as required.
- Generate and complete Trackwise records as required.
- Analyse all raw materials, in process samples and finished products in a timely and efficient manner to ensure quality and efficacy of the product.
- Assist in the preparation for customer/regulatory inspections.
- Prepare submission documentation in support of license applications.
- Identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
- Ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
- Complete all documentation correctly, in line with data integrity guidelines, free from errors, omissions or defects in order to achieve a high level of customer service and cGMP.
- Peer review documentation as required.
- Perform additional team tasks as agreed to support effective running of the Business.
- Support all other ongoing laboratory functions & requirements.
Health and Safety
- Ensure the requirements of Eirgen's Safety Statement are implemented.
- Continuously promote a positive safety culture by leading by example.
- Implement safety requirements as per site documentation including SOP's, Safety Statement and COP's.
- Report any defects/hazards as they arise.
Working at Eirgen – What to expect
At Eirgen, we have developed a diverse, people-centric, high performance culture where people are enabled to achieve their potential.
If you are working at Eirgen, then we think you've got something special. Our employees are high-performing and work as part of a cohesive team, they are dedicated people who are driven to succeed and are rewarded with competitive salaries and an attractive range of benefits including opportunities for career progression and continuing education.
Apply for the above role by sending your CV to including the job title in the subject.
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