Spclst, Engineering

Merck; Dublin; On-site; EUR 70,000 - 100,000; Full time

Job summary

Merck in Ireland invites applications for a Specialist MS&T (Analytical and Downstream Process Sciences) role focusing on supporting biologics drug substance manufacturing. You will contribute to analytical testing, process development, and technology transfer across the integrated MS&T team.

The role requires a Bachelor's degree in a relevant science and hands-on experience with analytical methods, chromatographic techniques, and data analysis.

Qualifications

• Bachelor's degree in Biological Sciences, Chemistry, Chemical Engineering, or Biological Engineering.
• Experience leading technical related projects.
• Experience in either Analysis of Biological Products or Downstream Drug Substance manufacturing, process development, process characterization studies, downstream technology, and/or process modeling.
• Experience in Analytical Science including use of HPLC/UPLC, CIEF, and Mass Spectrometry or designing and executing experimental programs with small-scale lab exposure (e.g., AKTA Avant chromatography, UFDF, NFF).
• Working knowledge of DOE design and data analysis (JMP or Design Expert).
• Technical writing skills.
• Experience with technology transfer, regulatory filing, and commercial drug substance manufacturing of biologics.
• Evidence of continuous professional development.
• Demonstrated leadership and change management with a continuous improvement focus.
• Proven track record of delivering high performance through coaching of a team.

Responsibilities

• Provide analytical testing support to the Process Sciences Team as required.
• Support analytical activities in the MS&T laboratory.
• Provide technical leadership for analytical projects, including experimental design, execution, data analysis, and interpretation.
• Develop, transfer, and qualify assays.
• Establish and validate analytical procedures.
• Assist in designing, supporting, and executing Downstream Process Sciences technical projects (e.g., UFDF, Chromatography, filtration) at small scale to support large-scale manufacturing.
• Execute experimental design, data analysis, and interpretation to resolve technical projects and complex investigations/deviations.
• Support, train, and mentor the Process Sciences team during small scale model run execution, including buffer preparation, lab-scale equipment set up, run execution, sampling, and data analysis.
• Author and review SOPs, protocols, and reports as required.
• Identify and support continuous improvement opportunities through Lean Six Sigma methodologies.
• Lead process improvement, technical problem-solving, and troubleshooting with end-to-end product focus.
• Assist in investigations, ensuring effective Root Cause Analysis and CAPAs.
• Support alignment and knowledge exchange with departments, development organizations, other commercial nodes, and external manufacturing partners

Skills

Analytical testing

Project leadership

Data analysis

DOE design

Technical writing

Process development

Chromatography

Statistical methods

Technology transfer

Education

Bachelor's degree in Biological Sciences, Chemistry, Chemical Engineering, or Biological Engineering

Tools

HPLC/UPLC

CIEF

Mass Spectrometry

AKTA Avant chromatography

UFDF

NFF

JMP

Design Expert

Job description

Job Description

Within our Company in Ireland, we work at the forefront of science and technology to advance manufacturing excellence and R&D across our Irish sites and global company network. We're always looking to make a difference for people, patients, and communities - from our Company in Ireland to the world.

Our Commitment to Ireland: Ireland is one of the Ireland's leading healthcare companies, having first established here over 50 years ago. We have a dynamic and diverse team of over 3,000 employees currently working across seven sites in Ballydine, Co Tipperary, Brinny, Co Cork, Dunboyne, Co Meath, Carlow, and Dublin, where, in addition, operate substantial Human Health and Animal Health businesses. Through our long-standing footprint in Ireland and over $6 billion invested across our Irish operations, our Irish sites manufacture many of our Company's top products, helping save and enhance lives in over 140 countries around the world

Our Biotech facility in Dublin began construction in 2018 and has progressed at an impressive rate since then. The site plays a pivotal role in the manufacture of our Company's biologics-based medicines, including immuno-oncology, and it has expanded our Company's current internal network of biologics drug substance manufacturing plants since full manufacturing operations began in 2021.

An exciting opportunity has arisen within The Specialist MS&T (Analytical and Downstream Process Sciences) delivers a range of technical support to the Biologics Drug Substance Business: supporting technology transfers, process characterisation and technical investigations within the Integrated Process Team, supporting significant projects in the MS&T laboratory, while creating an inclusive culture that energizes a Safety First, Quality Always, with a continuous improvement mindset.

Responsibilities

• Provide analytical testing support to the Process Sciences Team as required.
• Support analytical activities in the MS&T laboratory.
• Provide technical leadership for analytical projects, including experimental design, execution, data analysis, and interpretation.
• Develop, transfer, and qualify assays.
• Establish and validate analytical procedures.
• Assist in designing, supporting, and executing Downstream Process Sciences technical projects (e.g., UFDF, Chromatography, filtration) at small scale to support large-scale manufacturing.
• Execute experimental design, data analysis, and interpretation to resolve technical projects and complex investigations/deviations.
• Support, train, and mentor the Process Sciences team during small scale model run execution, including buffer preparation, lab-scale equipment set up, run execution, sampling, and data analysis.
• Author and review standard operating procedures (SOPs), protocols, and reports as required.
• Identify and support continuous improvement opportunities through Lean Six Sigma methodologies.
• Lead process improvement, technical problem-solving, and troubleshooting with end-toend product focus.
• Assist in investigations, ensuring effective Root Cause Analysis and CAPAs.
• Support alignment and knowledge exchange with departments, development organizations, other commercial nodes, and external manufacturing partners

What skills you will need:

• Bachelor's degree in Biological Sciences, Chemistry, Chemical Engineering, or Biological Engineering with 2+ years of experience.
• Experience leading technical related projects.
• Experience in either Analysis of Biological Products or Downstream Drug Substance manufacturing, process development, process characterization studies, downstream technology, and/or process modeling.
• Experience in either Analytical Science including use of HPLC/UPLC, CIEF, and Mass Spectrometry or designing and executing experimental programs in the laboratory, including small-scale lab experience (e.g., AKTA Avant chromatography, UFDF, NFF).
• Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software).
• Technical writing skills.
• Data Analysis, Estimation and Planning, Chromatography, HPLC/UPLC, Titration assay, Tecan, DOE, Process Design, Process Improvements, Project Planning, Regulatory Compliance, Root Cause Analysis (RCA), Six Sigma, Standard Operating Procedure (SOP), Technical Support, Technical Writing, Technology Transfer.
• Experience with technology transfer, regulatory filing, and commercial drug substance manufacturing of biologics.
• Evidence of continuous professional development.
• Demonstrated leadership and change management skills with a continuous improvement focus.
• Proven track record of delivering high performance through development and coaching of a team.
• Strong collaboration to promote knowledge sharing and implementation of best practices across the site.
• Desire to continuously learn, improve, and develop.

We keep the patient at the very heart of all that we do and strive to find solutions and tr