Formulation & Process Development Specialist

Formulation & Process Development Specialist

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 develop robust, capable, cost effective & safe manufacturing processes, materials
and products and support the efficient and effective transfer of new products & processes into
commercial production.

The role includes management of the following:
In this role you will act as a Subject Matter Expert for the development and transfer of drug product

formulations and process that meet patient needs

Primary responsibilities of this role include the following:

• Responsible for the in-house development of products and transfer of CMO projects into

Eirgen. Actively participates in the selection of CMO or CDMO projects for oral product

manufacturing. Prepares and reviews development protocols, reports, and production

documentation. Verifies products for commercial suitability according to regulatory

requirements. Leads the evaluation, improvement, and optimization of products and

processes to ensure safety, quality, delivery, and cost standards are met.

• Actively lead development process runs with Process Technicians and Operators.

• Establishes effective and transparent communication with the Pharmaceutical Development

department and other stakeholders across the company.

• Manages resources efficiently to achieve specific departmental and company objectives.

• Ensures that changes to existing processes or the implementation of new processes are

documented and carried out according to approved change control procedures and in

compliance with cGMP requirements.

• Works closely with R&D Analytical and R&D Formulation teams during formulation

development and broader stakeholders during CMO product transfer.

and leads knowledge transfer from R&D to Engineering, Maintenance, Production and

Quality ensuring robust knowledge transfer.

Health & Safety:

• Ensure requirements of Eirgen’s Safety Statement are implemented.

• Continuously promote a positive safety culture by leading by example & drive a high EHS, 5S

& housekeeping standard in areas under the roles control.

• Implement safety requirements as per site documentation including SOP’s, Safety

Statement and COP’s

About you

You are educated to a minimum of degree level in pharmaceutical sciences, chemistry or any related

science, while a post graduate qualification is advantageous. Your 4plus years' experience is in

Product Formulation and Performance, Process Development or Engineering with Pharma and New

Product Introduction project experience included.

Operations, process /technical support, projects or validation-based experience of oral solid dosage

manufacturing processes at lab scale, pilot scale and/or commercial scale is a requirement as well as

experience with technical transfers (sending site) for pharmaceutical products and with packaging

processes and technologies.

You exhibit strong capability of using DoE and other statistical software to analyze and correlate the

data with process output and predefined critical quality attributes. You are also familiar with

regulatory, validation and documentation requirements for product development, commercial

production and site transfers.

As a positive team member you will draw from your many skills such as strategic thinking, business

acumen, planning, multi-tasking, project and time management. You have the ability to form strong

relationships and negotiate and influence cross functionally, you 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 further education.

Apply for the above role by sending your CV to opportunities@eirgen.com including the job title in

the subject.