Job Description
A fantastic opportunity has arisen for aSr. Scientist, Analytical RD.
Bring energy, knowledge, innovation to carry out the following:
- Be able to drive work independently and work as directed by the Microbiology Lead(s) according to Company safety policies, cGMP and cGLP.
- Drive compliance with policies, procedures, guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in day to day activities.
- Lead and coordinate the method transfer of analytical techniques for Microbiology testing, including Rapid Methods.
- Plan, perform and troubleshoot multiple, complex methods and procedures where required.
- Participate in the peer review and approval of laboratory data.
- Provide technical guidance and apply expertise and critical thinking to help resolve technical issues.
- Coach and train colleagues and leads by example throughout department improving the quality of both individuals and teams for next scientific role.
- Oversee and guide implementation of procedures that comply with appropriate regulatory requirements.
- Manage project deliverables relating to qualification of analytical equipment and associated test methods.
- Ensure quality systems within the laboratories are within compliance to cGLP and cGMP, performing administrator tasks where required.
- Collaborate cross-functionally with area owners and stakeholders to ensure compliant laboratory operations.
- Manage supporting activities for general lab operations, EM, Facility testing, in-process and drug substance analysis studies.
- Lead and act as primary point of contact for laboratory projects, such as new product introduction analysis, method transfers, method verifications, and execution of laboratory studies.
- Oversee the laboratory testing schedule to achieve and maintain an efficient lean lab system.
- Maintain timelines, manage review and approval of validation and transfer protocols and reports; assist labs with sample/consumable logistics in support of validation and transfer
- Drive good housekeeping and hygiene standards within the laboratory.
- Participate and/or lead risk assessments, inspections, audits, incident investigations, implement and follow-up on corrective / preventative measures, drive permanent inspection readiness.
- Participate in internal and external audits and inspections, Contribute as Subject Matter Expert for assigned areas of responsibility.
- Communicate effectively across functions and departments to assist management and governance teams in risk escalation, issue management and mitigation plan development.
What skills you will need:
In order to excel in this role, you will more than likely have:
- A degree qualification in a relevant field (Biological Sciences/ Engineering), preferable for background in microbiology, An Advanced Degree (e.g., MSc) qualification is desirable.
- A minimum of 5-7 years experience working in a relevant academic or industry field.
- Technical Knowledge with Biologics drug substance manufacturing and microbiological testing techniques.
- Knowledge in the technical aspects and prior hands-on experience of analytical methods used for release, stability, process monitoring
- Knowledge of design and operation of automated systems such as GLIMS, trackwise and E-logs, SAP.
- Ability to think logically and be proactive under pressure.
- Ability to work as part of a team and on own initiative in a constructive manner
- Effective communicator and deep technical expertise in science, to be able to share and communicate that knowledge through training other analysts.
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.
We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the worlds 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 dont 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:
Continuous Improvement, Microbiological Test, Regulatory Requirements
Preferred Skills:
Current Employees applyHERE
Current Contingent Workers applyHERE
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:
08/8/2026*A job posting is effective until 11:59:59PM on the dayBEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFORE the job posting end date.
Requisition ID: R409052
