Technical Specialist, QC Biochemistry and Cell Biology

Job Description

A fantastic opportunity has arisen for a Technical Specialist Biochemistry & Cell Biology in our Dunboyne facility. This individual 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 in Dunboyne Biologics. 

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. 
• Review, evaluate, and approve Analytical Testing data.
• Complete special project/protocol testing in a timely manner under direction of Project Leads and/or Area Lead.
• Use sophisticated laboratory instrumentation and Global LIMS or other computerized systems for collecting, recording, and approving test data/results.
• Contribute to a team setting within the laboratory and project activities and potentially with other work teams to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support. 
• Works under minimal supervision. 
• Ensure area is always maintained in a GMP state while following all EHS and 5S guidelines. 
• Prepare and update SOPs as required. 
• Apply Lean principles such as 5S throughout daily work activities. 
• Ensure personal training requirements are met and that training records are current. Train staff as per business needs. 
• Drive the development of technical skills through coaching and motivate a high performing culture across the team. 
• Demonstrate a commitment to learning and personal development. 
• 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. 
• Champion site metrics to ensure targets are achieved, met and counter measures in place when applicable. 
• Execute company policies. 
• Support the preparation of laboratory protocol studies/validations as required. 
• Familiarity with code of federal regulations, and compendia requirements. 
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA and cGMP regulations. 
• Get actively involved by participating in inspections, GEMBA’s and Go-See’s. 
• Complete COMMIT cards to highlight ways of working within our SDWT’s and Hubs and across our site that support our COMMIT culture. 
• Consistently deliver on specific area Key Performance Indicators. 
• Operate to the highest standards of Safety, Quality, and Compliance. 
• Provide immediate feedback to others at any time to reinforce good safety and improvement behaviours and acts. 
• Routinely talk about any safety issues you are concerned about. 
• Know the hazards of the tasks you are performing, actively conduct risk assessments for inclusion into operational SOPs.
• Challenge yourself before starting any task and identify safety improvements and be an active participant of our site safety standards challenging the status quo. If something is out of the ordinary, or something changes, step back and reassess; if in doubt, do not do it.
• Challenge and identify improvements to the safety and environmental programmes on site. 
• Ensure you are effectively trained for the work you need to do, challenge the safety training if it is not effective. 
• Promote an environment where everyone speaks up for our culture of safety and looks out for one another. 
• Foster a continuous improvement environment and bring strong problem solving and troubleshooting capabilities. 
• Be a visible leader of safety initiatives and stay actively involved in safety forums. 
• Celebrate with use of proactive recognition tools that inspire teams and individuals you can collaborate with. 
• Provide coaching for the team members as part of the continuous improvement mindset. 
• Role model the behaviours that creates a culture of dignity and respect. 
• Encourage new and innovative approaches to improve the value stream. 
• Utilise real-time data analytics for making decisions on the value stream improvement initiatives. 
• Engage in implementing innovative solutions that drive a high-performance organisational culture that accommodates rapid growth and highly dynamic expectations ensuring attainment of site operational and development goals. Engage in other tasks as required.
• Create an environment of right first time in everything that we do through a focus on principles of lean, including simplification, standard work, visual management and a learning organisation. 

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).
• Excellent trouble shooting and problem solving skills. 
• Ability to think logically and be proactive under pressure. 
• Flexible and self-motivated. 

As a company, we are committed to 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:

Accountability, Accountability, Adaptability, Aseptic Manufacturing, Assay, Biochemical Assays, Biotechnology, Cell-Based Assays, cGMP Compliance, Data Analysis, Decision Making, Documentation Review, Enzyme Linked Immunosorbent Assay (ELISA), FDA Regulations, GMP Compliance, Hardware Implementation, Integrity Management, Interpersonal Communication, Interpersonal Relationships, Laboratory Operations, Laboratory Quality Control, Oral Communications, Quality Inspections, Quality Operations, Regulatory Compliance {+ 5 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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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:

12/16/2025

*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.