Job Description
We have an amazing opportunity at our R&D facility for a Scientist, Analytical R&D. The Biologics Analytical Research & Development department is seeking applicants for a Scientist position which is a laboratory-based scientific role tasked with analytical testing of drug substance for release, stability and characterisation of biologic products under GMP/GDP and analytical method validations/transfers. The successful candidate must function well and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment.
Our Dunboyne facility is a premier, state-of-the-art facility that enables and advances our best work. By integrating leading-edge technology with a dynamic, activity-based workspace, the facility will support seamless connection and collaboration within and across teams and functions. The facility will provide Biologics Drug Substance manufacturing for Clinical Supply, Registration & Commercial Launch.
Our site in Dunboyne serves as a magnetic force that attracts, recognises, and integrates people of diverse backgrounds and perspectives. Employees will feel not only that they belong in our Dunboyne site, but that the facility belongs to and is shaped by them.
The Scientist will run the daily activities in the BioChem laboratories.
What you will do:
Bring energy, knowledge, innovation and leadership to carry out the following:
* Execution of analytical method validations and transfers (among our different sites, and between Our facility and Clinical Research Organizations) and write technical protocols and reports.
* Execution of analytical testing of drug substance release, stability and characterisation for biologics under GMP/GDP.
* Troubleshoot methods to ensure seamless method qualification & execution in the laboratory.
* Support equipment maintenance, calibration and qualification & periodic review.
* Preparation of analytical methods, SOPs and other documents as required.
* Support Quality Events to ensure execution in Biologics AR&D is compliant to GMP standards.
* Other analytical activities in consultation with the Associate Director or designee.
* Works in accordance with applicable internal company regulations: safety, health and environmental protection.
* Cross-train Scientists within the department for new and existing technologies.
* Initiate, review, and support deviations, CAPAs, and, risk assessments, and change records as required.
* Execution and review of analytical testing of drug substance release, stability, method qualification, incoming goods, ID testing, and characterisation for biologics under GMP/GDP.
What skills you will need:
In order to excel in this role, you will more than likely have:
* M.S in analytical chemistry/biochemistry or related field or BSc with a minimum of 3 years of experience in the Pharmaceutical Industry.
* Experience with analytical testing with Ultrahigh Pressure Liquid Chromatography (UPLC)/High Performance Liquid Chromatography (HPLC), Capillary Electrophoresis, or other large molecule characterisation technique.
* Strong oral and written communication skills.
* Demonstrate Problem solving & technical troubleshooting skillset.
* Ability to work in a team environment with cross-functional interactions is essential.
* GMP working experience.
* Ability to organise and establish testing schedules and adhere to deadlines.
* Understanding of current manufacturing processes.
* Analyse and optimise current lab/business processes in the laboratories and support implementation activities of the technologies and methodologies.
Required Skills:
Accountability, Adaptability, Analytical Development, Analytical Method Development, Cell-Based Assays, Communication, Good Manufacturing Practices (GMP), Immunoassays, Interpersonal Relationships, Laboratory Information Management System (LIMS), Laboratory Techniques, Mammalian Cell Culture, Real Time Polymerase Chain Reaction (qPCR), Self Motivation, Standard Operating Procedure (SOP) Writing, Team Management, Technical Writing, Troubleshooting
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:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not Applicable
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
01/6/2026
*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.