Senior Formulation Development Scientist

4 days ago

Limerick, Limerick, Ireland beBeeChemistry Full time €75,000 - €105,000
Process Chemist Job Summary

We are seeking a highly skilled Process Chemist to lead and participate in projects focused on developing strategy with respect to chemistry, manufacturing, and controls (CMC) of combination drug devices.

This role will involve maintaining expertise in FDA, US Pharmacopeia, and European Pharmacopeia guidelines related to CMC regulatory topics.

  1. Maintaining high levels of expertise in FDA, US Pharmacopeia, and European Pharmacopeia guidelines related to CMC regulatory topics is crucial for this role.
  2. The selected candidate will provide oversight in the development of CMC strategies to support global regulatory strategy and submissions.
  3. Providing technical review of data and reports for accuracy and consistency with regulator's expectations is also essential.
  4. Collaborating with stakeholders to identify contract manufacturers and API vendor selection is another key responsibility.
  5. Leading or participating in engineering projects as a subject matter expert within the field of CMC and test method development is expected.
  6. Supporting the Investigation/Root Cause Analysis of OOS API results ensuring consistency in terms of methodology and regulatory expectations is important.
  7. Collaboration with other Post Market/Manufacturing Engineering Teams to ensure effective completion of all activities associated with Post Market Engineering projects/objectives is also necessary.
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 is expected.
  • Strong knowledge of medical device quality standards ISO13485/FDA practices and GMP, GLP or similar regulated industry standards is necessary.
  • Familiarity with FDA, US Pharmacopeia, and European Pharmacopeia and ICH CMC regulatory topics is also expected.
  • Proven analytical and problem-solving skills are essential.
  • Strong interpersonal skills and the ability to communicate across functions is necessary.

  • Staff & Senior Medical Scientist Haematology

    7 days ago

    Limerick, Limerick, Ireland Ttm Healthcare Limited Full time

    Role: Staff & Senior Medical Scientist HaematologyLocation: LimerickSalary: €43,892 - €88,021Job Type: Full Time PermanentTTM Healthcare Solutions are currently seeking aMedical Scientists inHaematologyto join aprivate HospitalinLimerick.1 staff gradeand1 senior gradevacancy are available.Key Requirements:CORU registration3 years post-qualification...

  • Senior Grade Medical Scientist Quality

    4 weeks ago

    Limerick, Limerick, Ireland Bon Secours Health System Full time

    Exciting Career Opportunity The Purpose of This Role: We are looking for a highly skilled and experienced Senior Medical Scientist Quality and I.T Coordinator to oversee quality assurance initiatives and maintain I.T systems within our laboratory.The successful candidate will play a key role in ensuring compliance with regulatory standards and improving...

  • Medical Scientist Haematology

    4 weeks ago

    Limerick, Limerick, Ireland Cpl Healthcare Full time

    Senior Grade Medical HaematologyKate Cowhig International Recruitment are currently recruiting experienced Medical Scientist, Limerick, Ireland.For further information & apply please Email your CV & CORU Registration to info@kcr.ieThe purpose of this role:Assist in implementing a clinical laboratory service that supports the clinical needs of the...

  • Medical Scientist Haematology

    4 weeks ago

    Limerick, Limerick, Ireland Cpl Healthcare Full time

    Senior Grade Medical HaematologyKate Cowhig International Recruitment are currently recruiting experienced Medical Scientist,Limerick, Ireland.For further information & apply please Email your CV & CORU Registration to ******The purpose of this role:Assist in implementing a clinical laboratory service that supports the clinical needs of the patientsEssential...

  • Medical Scientist Haematology

    4 days ago

    Limerick, Limerick, Ireland Cpl Full time

    Senior Grade Medical HaematologyKate Cowhig International Recruitment are currently recruiting experienced Medical Scientist, Limerick, Ireland.For further information & apply please Email your CV & CORU Registration to The purpose of this role:Assist in implementing a clinical laboratory service that supports the clinical needs of the patientsEssential...

  • Principal Scientist, Tsms Contamination Control Strategy

    4 weeks ago

    Limerick, Limerick, Ireland Eli Lilly And Company Full time

    Principal Scientist, TSMS Contamination Control Strategy - ADN RAMP TeamJoin to apply for thePrincipal Scientist, TSMS Contamination Control Strategy - ADN RAMP Teamrole atEli Lilly and CompanyPrincipal Scientist, TSMS Contamination Control Strategy - ADN RAMP Team1 week ago Be among the first 25 applicantsJoin to apply for thePrincipal Scientist, TSMS...

  • High Salary Medical Scientist Haematology

    4 weeks ago

    Limerick, Limerick, Ireland CPL Full time

    Senior Grade Medical HaematologyKate Cowhig International Recruitment are currently recruiting experienced Medical Scientist, Limerick, Ireland.For further information & apply please Email your CV & CORU Registration to [email protected]The purpose of this role:Assist in implementing a clinical laboratory service that supports the clinical needs of the...

  • Chief Medical Scientist Histology HSEMW12425

    5 days ago

    Limerick, Limerick, Ireland HSE Workplace Health & Wellbeing Full time

    Chief Medical Scientist Histology HSEMW RepostOverviewChief Medical Scientist Histology HSEMW RepostKey detailsLocation: UHL Laboratory DepartmentHealth region: HSE Mid WestCounty: LimerickContract type: Permanent WholetimeAdvert source: HSEAdvertisement Type: ExternalPost specificsDepth and breadth of experience in hospital pharmacy practice.Depth and...

  • Chief Medical Scientist Histology HSEMW12425

    3 days ago

    Limerick, Limerick, Ireland Health Service Executive Full time

    OverviewChief Medical Scientist Histology HSEMW Repost / Extended role at Health Service Executive.Reference: HSEMW12425Category: Health and Social Care ProfessionalsGrade: Medical Scientist - Chief 3876Advertisement source: HSEAdvertisement Type: ExternalImportant Information: This job is in the HSE.Health region: HSE Mid WestCounty:LimerickLocation: UHL...

  • Tech Support Scientist

    24 hours ago

    Limerick, Limerick, Ireland Serosep Ltd. Full time

    OverviewSerosep Ltd. is currently seeking a Tech Support Scientist to join our Technical Department. Reporting to the Technical Manager this role involves coordinating and responding to all clinical laboratory customer queries while maintaining quality procedures and documentation standards.ResponsibilitiesTo provide timely technical support to clinical...