Job Description
An amazing opportunity has arisen for an Associate Specialist, Drug Product Commercialisation, Development & Supply. This is an exciting and challenging opportunity to work on multiple Drug Product projects, contributing to product development and scale-up, new product introductions and technology transfers, as well as manufacturing support activities.
This position is for an Associate Specialist in the Commercialisation, Development and Supply (CDS) group. This group is responsible for process development of Active Pharmaceutical Ingredients (API), Oral Solid Dosage (OSD) forms and potent products from Phase IIb through regulatory filings, process validation, and into the first few years of commercial launch. The group is part of the Global Pharmaceutical and Commercialization (GPC) organization and collaborates with colleagues across the globe on developing new products.
First established in 1976, our Ballydine facility develops and supplies the active ingredients and final formulated product for a range of innovative medicines at its manufacturing and R&D facilities. Ballydine was our Company’s first site in Ireland, the Ballydine site is our Company’s primary small molecule pipeline commercialisation facility globally, operating as a European hub for quality, manufacturing, and engineering. Its highly skilled teams lead the way in the development of new medicines, including innovative treatments for Hepatitis C, HIV and immuno-oncology, the site exports to over 25 countries around the world.
Bring energy, knowledge, innovation to carry out the following:
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Plan, conduct, evaluate and interpret process development studies, including scale-up, drug product characterization, and design space development.
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Process validation.
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Clinical and formal stability batch manufacture
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Leading and participating in cross functional teams to carry out Quality Risk Assessments, Quality Investigations, Safety Assessments and Change Control Process
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Problem-solving skills are essential and knowledge of concepts of Quality by Design, including risk-based approaches to development, design of experiments, and process modelling, are desired.
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Support commercial supply activities such as:
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Manufacturing and cleaning recipe and documentation preparations.
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Technical support to manufacturing and cleaning campaigns.
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Trouble shooting, investigations and documenting process issues and deviations.
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Identifying and implementing process improvement and optimization opportunities.
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Other responsibilities include data analysis, technology evaluation, standard operating procedures (SOP) authorship and compliance with applicable safety and current good manufacturing practices.
What skills you will need:
In order to excel in this role, you will more than likely have:
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Minimum of 1-3 years relevant experience in Oral Solid Dosage Manufacturing
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Strong oral communication skills
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Proficiency in technical writing.
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Work independently and deliver work task on time.
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Bachelors or postgraduate degree in Chemical or Process Engineering or a Science related discipline.
We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.
As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.
Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.
We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.
Please feel free to speak to us about what flexibility means to you during your application.
So, if you are ready to:
Invent solutions to meet unmet healthcare needs, please apply today.
Required Skills:
Oral Solid Dosage, Problem Solving Tools, Process Development (PD)
Preferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
No Travel Required
Flexible Work Arrangements:
Not Applicable
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
NA
Job Posting End Date:
06/10/2026
- A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R395200
