Job Description

Our Company in Dunboyne 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 Company in Dunboyne, but that the facility belongs to and is shaped by them.

The Biologics Analytical Research & Development department is seeking applicants for a Senior Scientist position within the Biochemistry team. This is a laboratory-based scientific role tasked with solving complex analytical problems at the interface of biology, chemistry, and lab informatics disciplines to enable development of Biologics products. The successful candidate must function well and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment.

The Senior Scientist is expected to be a subject matter expert during execution of assay validations with expertise in analytical problem solving.

Main areas of responsibility include:

• Review execution of analytical method validations and transfers (among different Company sites, and between our Company and CROs) and write technical protocols and reports.

• Review and execution of analytical testing of drug substance release, stability and characterisation for biologics under GMP/GDP.

• Analyse and optimize current lab/business processes in the laboratories and support implementation activities of the technologies and methodologies.

• Review execution of analytical method validations and transfers (among different Company sites, and between our Company and CROs) and write technical protocols and reports.

• Technical Troubleshooting & Optimisation to support seamless method qualification.

• Collaborate with a global network of scientists to streamline and platform scientific methods entering Biologics AR&D at our Company in Dunboyne.

• Review and approval of analytical methods, SOPs and other documentation.

• Support Quality Events to ensure execution in Biologics AR&D is compliant to GMP standards.

• Works in accordance with applicable internal company regulations: safety, health and environmental protection.

• Coaching and mentoring for Scientists within the department.

• Ensure proper maintenance of the equipment, including calibration and qualification work. Leads functional area teams or technical forums with direct pipeline impact.

Required Education:

• Ph.D. in Analytical Chemistry/Biochemistry or related field or MSc with a minimum of 3 years of experience in the Biopharmaceutical Industry or Bachelor with 7 years of experience in the Biopharmaceutical Industry.

Required Experience and Skills:

• GMP working experience and a working knowledge of regulatory requirements.

• Experience with Ultrahigh Pressure Liquid Chromatography (UPLC)/High Performance Liquid Chromatography (HPLC), Capillary Electrophoresis, or other large molecule characterization technique.

• Ability to review and/or execute the qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process development.

• Knowledge of Analytical Methodologies and sound scientific understanding of Critical Quality Attributes as well as data analysis and statistics for setting specifications.

• Expertise in method validations and technology transfers.

• Effective organisational and multi-tasking skills with strong oral and written communication skills.

• Team player with ability to support peer to peer coaching and lead technical discussion with subject matter experts, Operations, Quality.

• Applies strong scientific and technical knowledge to shape and deliver on pipeline innovation.

• Leverage broad expertise to drive strategic, therapeutic, regulatory and scientific goals.

• Partners with Management to develop and execute scientific and enterprise strategy.

• Models and inspires a culture of collaboration, diversity & inclusion.

• Strong commitment to coaching, mentoring, and training Scientists.

Preferred experience and skills:

• Understanding of protein degradation mechanisms and link between analytical methodologies for analysis.

• Understanding of current manufacturing processes.

• Experience in analysis of various Biologic modalities (e.g., mAb, antibody-drug conjugate, fusion proteins, etc.).

• Certified in Lean Six Sigma or experience in Quality by Design.

Required Skills:

Accountability, Adaptability, Analytical Method Development, Assay Development, Bioanalytical Analysis, Biochemical Assays, Cell-Based Assays, Chromatographic Techniques, Communication, GMP Environments, Innovative Thinking, Nuclear Magnetic Resonance (NMR) Analysis, Process Analytical Technology (PAT), Strategic Thinking, Team Management, Technical Writing, Ultra Performance Liquid Chromatography (UPLC)

Preferred Skills:

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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:

12/25/2025

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