Assoc. Spclst, Quality Control

MSD; Dunboyne; On-site; EUR 70,000 - 100,000; Full time

Job summary

Merck & Co., Inc. in Dunboyne, Ireland, seeks an Associate Technical Specialist in Biochemistry & Cell Biology to support QC testing, develop methods, troubleshoot, and build capability in Biochemistry and analytical methods.

The role requires leading and coaching the QC team, performing advanced assays, preparing regulatory submissions, ensuring data integrity, and maintaining GMP compliance, while driving continuous improvement and readiness for inspections.

Qualifications

• Master’s degree with 5 years in biotech/pharma or PhD with 3 years.
• Leadership skills and experience managing daily activities.
• Lean Six Sigma experience preferred.
• Excellent written and oral communication; GMP aware.

Responsibilities

• Develop and coach the QC team on lab techniques to meet site goals.
• Support advanced assays requiring precise analytical skills in biochemistry and cell biology.
• Perform method execution, troubleshooting, and SOP updates.
• Prepare regulatory submissions, inspection readiness, and interact with inspectors.
• Maintain data integrity and ensure compliance with FDA and cGMP.
• Drive continuous improvement and achieve site KPIs.
• Assist with equipment qualification and method transfer/validation.

Skills

BioAssay

Biochemistry

ELISA Techniques

PCR Testing

Education

Master’s degree in Science/Quality/Technical disciplines

PhD in Science/Quality/Technical disciplines

Job description

Job Description

A fantastic opportunity has arisen for an Associate Technical Specialist Biochemistry & Cell Biology in our Dunboyne facility. The associate will be responsible for quality control support testing by providing technical expertise for the following activities method execution troubleshooting, establishment of methods, input in investigations, building capability related to Biochemistry and Cell Biology methods and Analytical methods.

Our facility in Dunboyne joined our network in September 2020. Our Dunboyne site is our Company’s first Biologics Drug Substance Single Use Commercialisation Facility, playing an important role in helping to commercialise key medicines. The cutting-edge innovation and collaboration between our Company’s research and manufacturing teams will significantly accelerate the time it takes to bring a medicine to market for the benefit of patients around the world.

Bring energy, knowledge, innovation to carry out the following

• Develop lead and coach the Quality Control team in relation to the technical aspect of the lab activities and drive a high-performance organisational culture that accommodates rapid growth and highly dynamic expectations, ensuring attainment of site operational and development goals.
• Support the performance and optimisation of advanced assays requiring precise analytical skills and an understanding of biological and chemical principles.
• Perform advanced assays requiring precise analytical skills and an understanding of biological and chemical principles.
• Complete special project/protocol testing in a timely manner under direction of Project Leads and/or Area Lead.
• Works under minimal supervision.
• Prepare and update SOPs as required.
• Drive the development of technical skills through coaching and motivate a high performing culture across the team.
• Provide support and expertise for the preparation of regulatory submissions, inspection readiness, health authority inspections including interaction with inspectors, responses to inspection observations, and monitoring of follow up actions.
• Support activities including general lab readiness, audit readiness, laboratory equipment qualification and analytical method technical transfer, verification and validation.
• Support the preparation of laboratory protocol studies/validations as required.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA and cGMP regulations.
• Consistently deliver on specific area Key Performance Indicators.
• Foster a continuous improvement environment and bring strong problem solving and troubleshooting capabilities.

What Skills You Will Need

In order to excel in this role, you will more than likely have

• A Master’s degree qualification in Science/Quality/Technical disciplines with 5 years’ experience in the biotechnology and/or pharmaceutical industry, (preferably both) Or PhD with 3 years’ experience
• Leadership skills and experience managing daily activities.
• Preferably Lean Six Sigma experience.
• Excellent written and oral communication skills.
• Strong understanding of cGMP requirements for manufacturing and/or systems and compliance.
• Required to work on their own initiative in a constructive manner in addition to working as part of a team.
• Excellent time management and organisational skills.
• Strong understanding of biochemical and cell biology methodology (ELISA, SDS-Page, Bio-Assays, PCR, and compendial assays, e.g. pH, Appearance, TOC etc) and strong technical skills.
• Strong understanding of GMP, ICH, USP and global compendia regulations and guidance's, particularly as related to analytical method development and validation.
• Experience with continuous quality/process improvement tools (As defined by the site, e.g. DMAIC, Lean QA, 5S etc).

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.

Required Skills

BioAssay, Biochemistry, ELISA Techniques, PCR Testing

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

08/22/2026

• 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

R392404