About Eirgen Pharma
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?
Eirgen was founded in 2005 and since then we have continually grown and now employ over 180 employees at our site in Waterford. Our strengths lie in our capability to rapidly introduce new products and add additional volume to existing products - ensuring supply for new product launches and expanding market opportunities.
What makes us different is that while we continue to grow our business, we have still maintained that small company feel to our culture which enables us to ensure that our employees are always front and centre in everything we do. By creating a progressive and dynamic working environment, where hard work and enjoyment aren't mutually exclusive, we have created a high performing, people-centric culture which allows us to work in an environment where the focus is always on ensuring that the patient comes first.
About the Job
In this role, you will act as a
Subject Matter Expert (SME)
for the development and transfer of drug product formulations and manufacturing processes that meet patient needs.
Primary Responsibilities
* Responsible for the in-house development of products and the transfer of In-house development/CMO/CDMO projects into EirGen.
* Actively participate product manufacturing.
* Prepare and review development protocols, technical reports, and production documentation.
* Verify products for commercial suitability in line with regulatory requirements.
* Lead the evaluation, improvement, and optimization of products and processes to ensure safety, quality, delivery, and cost standards are achieved.
* Actively lead development and process runs with Process Technicians and Operators.
* Establish effective and transparent communication with the Pharmaceutical Development department and cross-functional stakeholders.
* Manage resources efficiently to meet departmental and company objectives.
* Ensure all process changes and new process implementations are documented and executed in compliance with approved change control procedures and cGMP requirements.
* Work closely with NPI / R&D Analytical and R&D Formulation teams during formulation development and with broader stakeholders during CMO product transfer.
* Collaborate with the Commercial Value Stream during manufacturing process development.
* Lead effective knowledge transfer from R&D to NPI, Engineering, Maintenance, Production, and Quality functions, ensuring robust and sustainable implementation.
Health & Safety Responsibilities
* Ensure EirGen's Safety Statement requirements are fully implemented.
* Promote a positive safety culture by leading by example.
* Drive high standards in EHS, 5S, and housekeeping within areas of responsibility.
* Implement safety requirements in accordance with site documentation, including SOPs, Safety Statements, and COPs.
About You
* Educated to a minimum degree level in Pharmaceutical Sciences, Chemistry, Engineering in Chemistry, or a related scientific discipline. MSc or PhD qualification is advantageous.
* Minimum of
4+ years' experience
in Product Formulation and Performance, Process Development, or Engineering within the pharmaceutical industry.
* Hands-on experience with oral solid dosage form, semisolids, liquids, etc., manufacturing processes at laboratory, pilot, and/or commercial scale.
* Experience in technology transfers (sending site) for pharmaceutical products.
* Familiarity with packaging processes and technologies.
* Strong capability in applying Design of Experiments (DoE) and statistical software to analyse and correlate process data with predefined Critical Quality Attributes (CQAs).
* Solid understanding of regulatory and cGMP requirements.
Leadership & Personal Attributes
* Demonstrated strategic thinking and strong business acumen.
* Excellent planning, multitasking, project, and time management skills.
* Ability to build strong relationships and influence cross-functionally.
* Enjoys collaboration, continuous learning, continuous improvement, and problem-solving.
* A positive, proactive leader who leads by example.
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.
Direct applicants only.
We are not accepting assistance from recruitment agencies at this time.