Validation and Manufacturing Team Lead

2 months ago

Alloa, Clackmannanshire, United Kingdom LumiraDx Full time

Job Summary

LumiraDx is seeking a highly experienced Senior Team Leader to lead our Reagent Manufacturing team. As a key member of our operations team, you will be responsible for ensuring the delivery of high-quality reagents to support our commercial immunoassay manufacturing operations.

Key Responsibilities

  • Plan and schedule resources for validation activities and reagent manufacture and testing to ensure supply of reagent materials in line with strip production requirements.
  • Provide input and work with R&D to drive transfer of scalable, robust processes and test methods into manufacture.
  • Ensure creation of appropriate validation documentation and protocols in collaboration with supporting departments.
  • Facilitate purchase of suitable equipment for the manufacture and testing of reagents.
  • Ensure new raw material and consumable availability for newly introduced processes.
  • Support FMEA and H&S risk assessment activity to ensure all risks to product and people are sufficiently mitigated.
  • Ensure reagent manufacturing processes and associated testing are carried out safely and efficiently.
  • Provide input to validation plans for equipment, processes, and test methods.
  • Design, execute, and analyze experiments for assessing and improving batch-to-batch performance.

Quality and Regulatory Compliance

  • Ensure full GMP, GDP, and GLP compliance within the reagent manufacturing department.
  • Coordinate creation, update, and review of manufacturing SOPs, WIs, BRs, and protocols.
  • Follow and comply with all relevant internal quality and H&S processes and procedures.
  • Support and monitor raising and investigation of Non-conformances.
  • Technically review completed process documentation and reports.

Requirements

  • Experience of validation activities and operating within a GLP manufacturing laboratory environment.
  • Line management experience.
  • Detailed knowledge and experience of high-volume, commercial immunoassay manufacture and testing.
  • Good troubleshooting and problem-solving skills.
  • Computer literacy and data analysis interpretation skills.
  • Effective communication and people development skills.

Qualifications

Degree-level qualified or equivalent in a science subject is desirable, however, equivalent relevant work experience will also be considered.

  • Lead Reagent Manufacturing Specialist

    7 days ago

    Alloa, Clackmannanshire, United Kingdom LumiraDx Full time

    Job Summary As a Senior Team Leader in Reagent Manufacturing at LumiraDx, you will be responsible for ensuring the delivery of high-quality reagents that meet production timelines and Design for Manufacture requirements. You will manage a team of technicians and scientists in a GMP environment, responsible for the manufacture of reagents for commercial...

  • Senior Team Leader, Reagent Manufacturing

    2 weeks ago

    Alloa, Clackmannanshire, United Kingdom LumiraDx Full time

    Job OverviewWe are seeking a highly skilled Senior Team Leader to lead our Reagent Manufacturing team. As a key member of our team, you will be responsible for ensuring the delivery of validated assays into the manufacturing department, meeting the consistently high quality required for progression to Production and Design for Manufacture requirements.Key...

  • Senior Team Leader, Reagent Manufacturing

    2 months ago

    Alloa, Clackmannanshire, United Kingdom LumiraDx Full time

    Job SummaryWe are seeking a highly skilled Senior Team Leader to join our Reagent Manufacturing team at LumiraDx. As a key member of our team, you will be responsible for ensuring the delivery of validated assays into the manufacturing department, meeting the consistently high quality required for progression to Production and Design for Manufacture...

  • Senior Team Leader, Reagent Manufacturing

    2 months ago

    Alloa, Clackmannanshire, United Kingdom LumiraDx Full time

    Job SummaryWe are seeking a highly skilled Senior Team Leader to join our Reagent Manufacturing team at LumiraDx. As a key member of our team, you will be responsible for ensuring the delivery of validated assays into the manufacturing department, meeting the consistently high quality required for progression to Production and Design for Manufacture...

  • Senior Team Leader, Reagent Manufacturing

    2 weeks ago

    Alloa, Clackmannanshire, United Kingdom LumiraDx Full time

    Job OverviewThe Senior Team Leader, Reagent Manufacturing will be responsible for ensuring the delivery of validated assays into the manufacturing department that meet the consistently high quality required for progression to Production and that meet the Design for Manufacture requirements.This role will oversee the routine manufacture of validated assays to...

  • Senior Team Leader, Reagent Manufacturing Specialist

    2 months ago

    Alloa, Clackmannanshire, United Kingdom LumiraDx Full time

    Job DescriptionKey ResponsibilitiesEnsure the delivery of validated assays into the manufacturing department, meeting high quality standards and Design for Manufacture requirements.Manage day-to-day activities and performance of multiple department teams to meet production timelines.Maintain a validated manufacturing environment and oversee investigations...

  • Senior Team Leader, Reagent Manufacturing Specialist

    2 months ago

    Alloa, Clackmannanshire, United Kingdom LumiraDx Full time

    Job DescriptionKey ResponsibilitiesEnsure the delivery of validated assays into the manufacturing department, meeting high quality standards and Design for Manufacture requirements.Manage day-to-day activities and performance of multiple department teams to meet production timelines.Maintain a validated manufacturing environment and oversee investigations...

  • Senior Team Leader, Reagent Manufacturing Specialist

    2 months ago

    Alloa, Clackmannanshire, United Kingdom LumiraDx Full time

    Job SummaryWe are seeking a highly skilled Senior Team Leader to join our Reagent Manufacturing team at LumiraDx. As a key member of our team, you will be responsible for ensuring the delivery of high-quality reagents to support our commercial immunoassay products.Key ResponsibilitiesPlan and schedule resources for validation activities and reagent...

  • Senior Team Leader, Reagent Manufacturing Specialist

    2 months ago

    Alloa, Clackmannanshire, United Kingdom LumiraDx Full time

    Job SummaryWe are seeking a highly skilled Senior Team Leader to join our Reagent Manufacturing team at LumiraDx. As a key member of our team, you will be responsible for ensuring the delivery of high-quality reagents to support our commercial immunoassay products.Key ResponsibilitiesPlan and schedule resources for validation activities and reagent...

  • Senior Team Leader, Reagent Manufacturing

    4 weeks ago

    Alloa, Clackmannanshire, United Kingdom LumiraDx Full time

    Job Title: Senior Team Leader, Reagent ManufacturingAbout the Role:We are seeking a highly skilled and experienced Senior Team Leader to join our Reagent Manufacturing team at LumiraDx. As a key member of our team, you will be responsible for ensuring the delivery of high-quality reagents to support our commercial immunoassay manufacturing operations.Key...

  • Senior Team Leader, Reagent Manufacturing

    4 weeks ago

    Alloa, Clackmannanshire, United Kingdom LumiraDx Full time

    Job Title: Senior Team Leader, Reagent ManufacturingAbout the Role:We are seeking a highly skilled and experienced Senior Team Leader to join our Reagent Manufacturing team at LumiraDx. As a key member of our team, you will be responsible for ensuring the delivery of high-quality reagents to support our commercial immunoassay manufacturing operations.Key...

  • Manufacturing Scientist

    3 weeks ago

    Alloa, Clackmannanshire, United Kingdom CV Library Full time

    Production Scientist Job DescriptionOur client, a leading diagnostic manufacturer and developer, is seeking a skilled Production Scientist to join their team in Alloa. The ideal candidate will have experience in Medical Devices or GMP and be responsible for preparing buffers/solutions, pad materials, and assembling lateral flow tests.Main...

  • Manufacturing Scientist

    3 weeks ago

    Alloa, Clackmannanshire, United Kingdom CV Library Full time

    Production Scientist Job DescriptionOur client, a leading diagnostic manufacturer and developer, is seeking a skilled Production Scientist to join their team in Alloa. The ideal candidate will have experience in Medical Devices or GMP and be responsible for preparing buffers/solutions, pad materials, and assembling lateral flow tests.Main...

  • Manufacturing Scientist

    4 weeks ago

    Alloa, Clackmannanshire, United Kingdom CV Library Full time

    Production Scientist Job DescriptionOur client, a leading diagnostic manufacturer and developer, is seeking a skilled Production Scientist to join their team in Alloa. The ideal candidate will have experience in Medical Devices or GMP and be responsible for preparing buffers/solutions, pad materials, and assembling lateral flow tests.Main...

  • Manufacturing Scientist

    4 weeks ago

    Alloa, Clackmannanshire, United Kingdom CV Library Full time

    Production Scientist Job DescriptionOur client, a leading diagnostic manufacturer and developer, is seeking a skilled Production Scientist to join their team in Alloa. The ideal candidate will have experience in Medical Devices or GMP and be responsible for preparing buffers/solutions, pad materials, and assembling lateral flow tests.Main...

  • Manufacturing Scientist

    1 month ago

    Alloa, Clackmannanshire, United Kingdom CV Library Full time

    Production Scientist Job DescriptionOur client, a leading diagnostic manufacturer and developer, is seeking a skilled Production Scientist to join their team in Alloa. The ideal candidate will have experience in Medical Devices or GMP and be responsible for preparing buffers/solutions, pad materials, and assembling lateral flow tests.Main...

  • Manufacturing Scientist

    1 month ago

    Alloa, Clackmannanshire, United Kingdom Stem Recruitment Full time

    Production Scientist OpportunityWe are seeking a skilled Production Scientist to join our team at an ambitious diagnostic manufacturer and developer based in Alloa. The successful candidate will be responsible for preparing buffers/solutions, pad materials, and assembling lateral flow tests, as well as equipment maintenance and test assembly.Key...

  • Manufacturing Scientist

    4 weeks ago

    Alloa, Clackmannanshire, United Kingdom Stem Recruitment Full time

    Production Scientist OpportunityWe are seeking a skilled Production Scientist to join our team at an ambitious diagnostic manufacturer and developer based in Alloa. The successful candidate will be responsible for preparing buffers/solutions, pad materials, and assembling lateral flow tests, as well as equipment maintenance and test assembly.Key...

  • Manufacturing Scientist

    4 weeks ago

    Alloa, Clackmannanshire, United Kingdom Stem Recruitment Full time

    Production Scientist OpportunityWe are seeking a skilled Production Scientist to join our team at an ambitious diagnostic manufacturer and developer based in Alloa. The successful candidate will be responsible for preparing buffers/solutions, pad materials, and assembling lateral flow tests, as well as equipment maintenance and test assembly.Key...

  • Manufacturing Scientist

    1 month ago

    Alloa, Clackmannanshire, United Kingdom Stem Recruitment Full time

    Production Scientist OpportunityWe are seeking a skilled Production Scientist to join our team at an ambitious diagnostic manufacturer and developer based in Alloa. The successful candidate will be responsible for preparing buffers/solutions, pad materials, and assembling lateral flow tests, as well as equipment maintenance and test assembly.Key...