Job Title : Analytical Development Chemist (Validation)Location : Waterford, County WaterfordCompany : EirGenSalary : Open Date : 2023-05-09Close Date : 2023-09-09
Analytical Development Chemist – R&D
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 Team accommodates our development and analytical scientists working on the next generation
of treatments for the company and its clients.
About the Job
You will support product development and clinical supply by transferring and validating analytical
test methods.
You will:
Transfer and validate robust, sound analytical methods.
Draft/review test methods, validation protocols and reports as applicable.
Prepare submission documentation in support of license applications.
Take part in/lead laboratory investigations.
Liaise directly with customers and contract laboratories and attend conference calls as
required.
Attend internal project review meetings as required.
Assist in the preparation for customer/ regulatory inspections.
Identify and make recommendations for improvements as part of a team within or outside
the department in order to ensure continuous improvement.
Analyse all raw materials, in process samples and finished products in a timely and efficient
manner to ensure quality and efficacy of the product.
Ensure that all work is 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. To peer
review documentation as required.
Perform additional team tasks as agreed to support effective running of the Business.
Support all other on-going laboratory functions & requirements.
Ensure the requirements of EirGen’s Safety Statement are implemented, report any
defects/hazards and continuously promote a positive safety culture by leading by example.
About you
You are qualified to a minimum of degree level in Analytical Chemistry/ Pharmaceutical Science or a
related discipline and ideally have some experience working in a related technical environment.
You are competent in a range of analytical methods (HPLC/Dissolution), with knowledge of GMP and
ideally project management skills. You 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.
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 up to date CV to [email protected] including the
job title in the subject.