Validation and Manufacturing Team Lead
2 weeks ago
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.
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Alloa, Clackmannanshire, United Kingdom LumiraDx Full timeJob 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...
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Alloa, Clackmannanshire, United Kingdom LumiraDx Full timeJob 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...
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Alloa, Clackmannanshire, United Kingdom LumiraDx Full timeJob 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...
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Alloa, Clackmannanshire, United Kingdom LumiraDx Full timeJob 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...
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Alloa, Clackmannanshire, United Kingdom LumiraDx Full timeJob 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...
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