I'm looking for...
close

Did you know that your Internet Explorer is out of date?

To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.
A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.

crome
Google Chrome		 IE
Internet Explorer		 firefox
Mozilla Firefox		 opera
Opera

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Job Tools
Contact Info
Siobhan Ryan
Life Science

+353 1 507 9254
[email protected]
Connect with me on
Hot Science Jobs
Microbiology Manager
Dublin
Director of Regulatory Affairs
Galway
Senior Product Development Engineer
Galway
Senior Research and Development Engineer
Galway
Senior Design Engineer
Dublin
Senior Electronic Engineer
Dublin
Maintenance Reliability Engineer
Cork
R&D Engineer
Galway
R&D Manager
Galway
Quality Manager
Dublin
Engineering Shift Technician
Dublin
Continuous Improvement Coach
Limerick
Maintenance Manufacturing Technician
Kilkenny
R&D Engineer
Galway
CTO
Dublin
Injection Moulding Engineer
Athlone
Senior Electronic Engineer
Dublin
Project Engineer
Louth
Principal Design and Development Enginee
Galway
Product Specialist (Endoscopy)
Dublin
Senior Design Assurance Engineer
Galway
Senior R&D Engineer
Galway
Senior QC Microbiology
Dublin
Design Assurance Engineer
Galway
Product Development Engineer
Galway
Principal R&D Engineer
Galway
Senior Quality Engineer
Dublin
Senior R&D Engineer
Galway
Production Operator
Carlow
Analytical Scientist
Meath
EHS Officer
Dublin
Project Manager - R&D
Galway
Project Engineer
Limerick
Process Engineer
Roscommon
Product Development Engineer
Dublin
Senior R&D Engineer
Galway
R&D Engineer
Galway
Senior R&D Engineer
Galway
Senior Recruitment Consultant
Republic of Ireland
Senior R&D Engineer
Galway
R&D Director
Galway
R&D Manager
Galway
Senior Quality Engineer
Dublin
R&D Engineer
Galway
R&D Manager
Connaught
Staff Systems Engineer
Limerick
Senior Quality Systems Engineer
Galway
Senior R&D Engineer
Galway
Regulatory Affairs Associate
Cork
Technical Transfer Specialist - Remote
Republic of Ireland
Senior Quality Engineer
Dublin
Design Assurance Engineer
Galway
E&I Turnover Engineer
Carlow
Design Assurance Engineer
Clare
Utilities Engineer
Dublin
Senior Design Assurance Engineer
Athlone
Product Development Technician II
Galway
Senior Clinical Affairs Specialist (Remo
Republic of Ireland
Principal R&D Engineer
Galway
R&D Manager
Connaught
Clinical Research Associate
Cork
Senior R&D Engineer
Galway
Product Development Engineer
Dublin
Senior Electronic Engineer - Regulated M
Galway
Strategic Automation Lead
Waterford
Project Manager
Kildare
Senior Mechanical Engineer
Dublin
Quality Technician
Dublin
Senior Quality Engineer
Leitrim
Senior Product Development Engineer
Galway
R&D Manager
Connaught
Senior R&D Engineer
Galway
R&D Manager
Athlone
Quality Engineer
Galway
Manufacturing Technician
Clare
Product Development Manager
Galway
R&D Director
Galway
Application Software Engineer
Galway
Customer Services Manager (Pharmaceutica
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
DeltaV Lead Automation Engineer
Tipperary
Senior Equipment Design Engineer
Dublin
Senior Regulatory Affairs Specialist
Athlone
CTO
Galway
Manufacturing Technician
Clare
Senior R&D Engineer
Dublin
Senior Design Engineer
Dublin
Manufacturing Engineer
Cork
Quality Assurance Associate
Cork
Product Development Engineer II
Athlone
Electronic Engineering
Dublin
R&D Engineer
Galway
Senior Process Engineer
Galway
Senior Validation Engineer
Dublin
Quality Control Analyst (shift)
Carlow
R&D Manager
Dublin
Project Engineer
Cork
Senior Recruitment Consultant
Dublin
Senior Operations Engineer
Galway
Responsible Person (RP)
Republic of Ireland
Quality Manager
Galway
Design Assurance Engineer
Clare
Process Chemist
Limerick
Senior Associate Quality Control
Dublin
Validation Engineer
Athlone
Principal Device Engineer
Dublin
Senior Design Engineer
Dublin
Senior Equipment Design Engineer
Dublin
Product Development Engineer
Dublin
Quality Specialist
Clare
Senior Recruitment Consultant
Republic of Ireland
Senior R&D Engineer
Galway
Injection Moulding Engineer
Leitrim
Principal R&D Engineer
Galway
Senior Validation Engineer
Louth
Senior Quality Engineer
Dublin
Product Development Engineer II
Athlone
Regulatory Associate
Cork
Senior Regulatory Affairs Specialist
Athlone
R&D Engineer
Clare
R&D Engineer
Dublin
R&D Lifecycle Manager
Connaught
Technology Transfer Specialist
Meath
Engineering Support Specialist
Louth
Senior R&D Engineer
Clare
Director Engineering & Supply Chain
Galway
Senior Quality Engineer
Galway
Senior R&D Engineer
Dublin
Injection Molding Engineer
North Leinster
Principal Quality Engineer
Galway
Sales/Customer Service Administrator
Clonmel
Quality Engineer
Athlone
Senior Research & Development Engine
Limerick
Senior Process Engineer
Longford
Growth Manager (Healthcare)
Dublin
Associate Director - Manufacturing &
Limerick
Design Assurance Program Manager
Galway
R&D Engineer
Galway
Health & Safety Specialist
Dublin
Quality Engineer
Galway
Senior R&D Engineer
Galway
Quality Specialist
Tipperary
Lead Maintenance Technician
Kilkenny
Quality Assurance Team Lead
Cork
Senior Engineering Manager
Limerick
R&D Manager
Athlone
Senior Operations Engineer
Galway
Senior Manufacturing Engineer
Galway
Maintenance Electrician
Limerick
Reliability Engineering Consultant - Rem
Republic of Ireland
Senior Process Engineer
Dublin
Senior R&D Engineer
Galway
Manufacturing Engineer
Galway
Technical Life Cycle & Engineering M
Galway
Maintenance Technician
Kilkenny
Quality Engineer
Galway
Product Development Engineer
Galway
Senior Quality Engineer
Dublin
Cleaning Validation Specialist
Cork
Senior Maintenance Technician
Roscommon
Senior Process Development Engineer
Galway
R&D Engineer
Galway
Senior Manufacting Engineer
Republic of Ireland
Project Manager
Kildare
Senior Project Engineer - R&D
Galway
Quality Engineer
Athlone
Quality Engineer
Galway
Sr Electrical Engineer
Galway
Senior Regulatroy Affairs Specialsit
Galway
Senior Equipment Design Engineer
Dublin
Injection Molding Engineer
North Leinster
Quality Assurance Engineer
Longford
R&D Director
Galway
Change Control SME
Cork
Senior R&D Engineer
Dublin
Project Manager
Galway
R&D Manager
Connaught
R&D Engineer
Galway
Buyer / Planner
Sligo
Senior Regulatory Affairs Specialist
Athlone
R&D Manager
Galway
Principal Process Equipment Engineer
Dublin South
Senior Quality Systems Engineer
Galway
Project Manager - R&D
Galway
R&D Senior Program Manager
Galway
Process Engineer
Roscommon
Project Manager Design Assurance
Galway
Sr Electrical Engineer
Galway
Product Development Engineer
Dublin
R&D Manager
Galway
Senior Quality Engineer
Galway
Senior R&D Engineer
Galway
Injection Moulding Engineer
Athlone
QA Manager
Canada
R&D Engineer
Galway
Quality Engineer
Galway
Electronic Engineer
Dublin
R&D Director
Galway
Calibration Technician
Republic of Ireland
Principal Instrumentation & Calibrat
Limerick
Territory Sales Specialist (Life Science
Belfast City
Electronic Engineer
Dublin
R&D Manager
Galway
Product Development Technician II
Galway
Senior Regulatory Specialist
Cork
Manufacturing Technician
Galway
R&D Engineer
Galway
Senior Quality Control Associate
Dublin South
Mechanical Engineer
Dublin
Quality Manager
Dublin
Senior Associate Quality Control (Shift)
Dublin
R&D Engineer
Dublin
Senior R&D Engineer-New Product Deve
Westmeath
Quality Technician
Dublin
Principal R&D Engineer
Galway
Quality Engineer
Athlone
Product Development Manager
Galway
Software Design Assurance Engineer
Dublin
Senior Process Engineer
Carlow
Injection Molding Engineer
North Leinster
Sourcing Specialist
Tipperary
QA Engineer
Leitrim
Design Assurance Program Manager
Galway
Senior Equipment Design Engineer
Dublin
Senior Equipment Engineer
Dublin
Senior Quality Engineer
Leitrim
Apply for this job

Name:

Surname:

Email:

Phone:

Cv:

Salary Expectations:

Education:

Experience:

Current Location:

Notice Period:

Write here your cover note:


If you would like us to create a jobseeker account for you, giving you access to
account management, job alerts and one-click applications, then please tick this box

If you are having difficulty you can always email your cv to [email protected]
Details

Process Chemist


Reference:SR-AWJW-302520) Location: Limerick
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Chemist

Our client, a leading global medical devices company, is now seeking a Chemist to join their team in Limerick.

The primary function of this position is to lead and/or participate in projects focused on developing strategy with respect to chemistry, manufacturing, and controls (CMC) of combination drug devices, specifically providing oversight in method development and validation, compendial method verification and transfer, specification/acceptance criterion development, stability testing, out of specification (OOS) investigation, post-approval manufacturing changes, verification of active pharmaceutical ingredient (API) components to recognized compendial standards and API vendor qualifications and audit.

This is very much a strategic, "desk-based" role, with a strong focus on process and problem solving.

Our client operates a hybrid working model, so there is good flexiblity in terms of the onsite requirement.

See outline of duties and responsibilities below;


  • Maintain high level of expertise in FDA, US Pharmacopeia and/or European Pharmacopeia and ICH guidelines related to CMC regulatory topics.
  • Provide oversight in the development of CMC strategies to support global regulatory strategy and submissions and Support submissions pertinent to CMC for global regulators.
  • Technically review data and reports for accuracy and consistency with regulator’s expectations (including, but not limited to stability data and lot release data such as HPLC, Particulate, Dissolution).
  • Provide CMC expertise and collaborate with stakeholders to identify contract manufacturers, API vendor selection, qualification and support audits of same.
  • Lead or participate in engineering projects serving as subject matter expert within the field of CMC and test method development.
  • Provide input on new product introduction and assessing proposed manufacturing changes and provide guidance during implementation of product changes.
  • Support the Investigation / Root Cause Analysis of OOS API results ensuring consistency in terms of methodology and regulatory expectations.
  • Collaborate with other Post Market / Manufacturing Engineering Teams to ensure the effective completion of all activities associated with Post Market Engineering projects / objectives.
  • Collaborate and interact effectively with other internal companies and global functions within the organisation (e.g., Regulatory Affairs, Engineering, Operations (Manufacturing), and Quality) to develop and implement CMC strategies.
  • Ensure effective reporting to the Post Market Engineering management team.
  • Work closely to build effective relationships with other functions in particular Production, Quality and Regulatory teams.





Qualifications / Requirements:


  • Bachelor’s degree, Masters or PhD is required, preferably in engineering/science or a related field.
  • Minimum of 3 years’ relevant experience with CMC.
  • Strong knowledge of medical device quality standards ISO13485/FDA practices and GMP, GLP or similar regulated industry standards.
  • Familiarity with FDA, US Pharmacopeia and/or European Pharmacopeia and ICH CMC regulatory topics.
  • Proven analytical and problem-solving skills.
  • Strong interpersonal skills and the ability to communicate across functions.
  • Familiarity with statistical methods, analysis, and interpretation.
  • Ability to work on multiple projects, organize, and prioritize within time constraints.
  • Familiarity with Microsoft Office software.
  • High self-motivation.
  • Willingness and availability to travel on company business.