Senior Analytical 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 the Job
In this role you will lead the analytical team to deliver commercial and development analytical testing in accordance with required timelines and perform testing in accordance with procedure.
- Supervise the analytical team and run the daily lab meetings to achieve required
- Be the technical expert on commercial and product testing where you are
- Perform technical review of documentation on behalf of the team lead as
- Attend and lead customer meetings on projects and commercial testing on
- behalf of your team
- Lead 5s/H&S/GMP inspections in the laboratory as required
- Complete laboratory investigations (Deviation/OOS/Safety) in a timely manner,
- identifying root cause in line with expected timelines
- Lead in Commercial/Validation/Transfer/Verification/Stability studies 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.
- Draft/ review test methods, validation/verification/transfer protocols and
- reports as applicable
- Complete preparation for customer/ regulatory inspections and perform role of
- SME during inspections.
- Prepare submission documentation in support of license applications.
- Identify and deliver improvements as part of a team within or outside the
- department in order to ensure continuous improvement.
- Report any defects/hazards as they arise
You are qualified to a minimum of degree level (or equivalent) in chemistry, pharmaceutical science or a related discipline and have at least five years’ experience working in a related technical environment. You possess a broad understanding of regulatory requirements for submission of dossiers in EU, USA, Japan and other jurisdictions, knowledge of project management skills and are proficient in the use of HPLC/Empower & all analytical techniques.
You demonstrate key competencies including excellent communication skills - verbal & written, attention to detail, organisational and problem solving ability, delivery of targets and professionalism.
You will demonstrate the following behaviours – strong safety awareness, leadership, influencing, decisiveness, teamwork & collaboration, compliance & adherence to regulations and lean thinking.
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 further education.
Apply for the above role by sending your CV to email@example.com including the job title in the subject.