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 followingactivities: method execution troubleshooting, establishment of methods, input in investigations,building capability related to Biochemistry and Cell Biology methods and Analytical methods inDunboyne 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 labactivities 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 skillsand an understanding of biological and chemical principles.Perform advanced assays requiring precise analytical skills and an understanding of biological andchemical 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 cultureacross the team.
* Provide support and expertise for the preparation of regulatory submissions, inspection readiness,health authority inspections including interaction with inspectors, responses to inspectionobservations, and monitoring of follow up actions.
* Support activities including general lab readiness, audit readiness, laboratory equipmentqualification 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 andcGMP regulations.
* Consistently deliver on specific area Key Performance Indicators.
* Foster a continuous improvement environment and bring strong problem solving andtroubleshooting 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).
* 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.
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):
Required Skills:
Adaptability, Adaptability, Aseptic Manufacturing, Assay, Biochemical Assays, Cell-Based Assays, Cell Physiology, cGMP Compliance, Coach Team Members, Data Analysis, Decision Making, Documentation Review, Enzyme Linked Immunosorbent Assay (ELISA), FDA Regulations, GMP Compliance, Integrity Management, Interpersonal Relationships, IS Audit, Laboratory Operations, Laboratory Quality Control, Management Process, Quality Control Management, Quality Inspections, Quality Operations, Regulatory Compliance {+ 5 more}
Preferred Skills:
Job Posting End Date:
07/7/2025
*A job posting is effective until 11:59:59PM on the day BEFOREthe 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:R348905
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