Senior Specialist MS&T (Analytical Sciences)

Dublin - Ireland

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Job Description

The Senior Specialist MS&T (Analytical Sciences) provides a range of analytical technical support to the particular Manufacturing Sciences and Technology (MS&T) Process Sciences Manufacturing and Quality Control Acting as Analytical Method and PAT SME while taking a lead in utilising the latest innovations in technology and automation to create a workplace of the future.

Responsibilities:

Serving as a biologics analytics and characterization subject matter expert providing technical input to teams and coaching to associate staff. Provide technical leadership for:
- Experimental design execution data analysis and interpretation.
- Development transfer and qualification of assays.

Lead and support various manufacturing science and technology organizational initiatives as needed (examples include safety financial forecasting work standardization etc).
Technical point of contact for Process Analytical Technologies (PAT)

Authoring and reviewing of documents including User Requirements Specifications (URSs) Risk Assessments Protocols Reports Standard Operating Procedures (SOPs) work instructions.
Technical lead for characterization testing ensuring testing conducted either internally or externally.
Serving as a key member during internal audits and external inspections/audits
Supporting multidisciplinary teams (manufacturing science and technology quality analytics regulatory) for process improvement and troubleshooting with end-to-end product focus

Qualification and Experience

Bachelors degree (or higher) in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry
Have excellent oral and written communication skills with the ability to effectively articulate understanding of process science.

Experience with analytical testing in support of upstream cell culture and downstream purification of biological molecules.
Experience with technology transfer regulatory filing and commercial drug substance manufacturing of biologics is a plus.

Analytical Chromatography experience ideally with some Mass Spectrometry experience
Prior experience in drug substance process development process characterisation studies process performance qualification and validation site readiness batch record reviews authoring regulatory CTD sections and/or working with external contract organisation for development and/or manufacturing.
Working knowledge of statistical methods for DOE design and data analysis (e.g. JMP or Design Expert software)
Working knowledge of statistical process control (SPC) multivariate analysis (MVDA) and/or process analytical technologies (PAT) techniques for biologics processes.

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:

Adaptability Adaptability Assay Development Biochemical Assays Cell-Based Assays Cell Cultures Chemistry Data Analysis Data Interpretations Detail-Oriented Documentations Estimation and Planning High-Performance Liquid Chromatography (HPLC) Interdisciplinary Collaboration Interpersonal Relationships Liquid Chromatography-Mass Spectrometry (LC-MS) Mammalian Cell Culture Mass Spectrometry (MS) Process Design Process Improvements Project Planning Regulatory Compliance Root Cause Analysis (RCA) Statistical Process Control (SPC) Technical Leadership 1 more

Preferred Skills:

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):

Job Posting End Date:

10/17/2025

*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.

Required Experience:

Senior IC

Job DescriptionJob DescriptionThe Senior Specialist MS&T (Analytical Sciences) provides a range of analytical technical support to the particular Manufacturing Sciences and Technology (MS&T) Process Sciences Manufacturing and Quality Control Acting as Analytical Method and PAT SME while taking a le...