Senior Team Leader, Reagent Manufacturing Specialist

2 months ago

Alloa, Clackmannanshire, United Kingdom LumiraDx Full time
Job Summary

We 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 Responsibilities
  • Plan and schedule resources for validation activities and reagent manufacture to meet supply requirements.
  • Collaborate with R&D to drive the transfer of scalable processes and test methods into manufacture.
  • Ensure creation of validation documentation and protocols in collaboration with QA and Product Assurance.
  • Facilitate the purchase of equipment for reagent manufacture and testing, including related documentation and validation activities.
  • Ensure new raw material and consumable availability for newly introduced processes and timely upload of real-time material and labor data into the ERP system.
  • Support FMEA and H&S risk assessment activities to mitigate risks to product and people.
  • Ensure safe and efficient reagent manufacturing processes and associated testing on shift.
  • Provide input to validation plans for equipment, processes, and test methods.
  • Design, execute, and analyze experiments to assess and improve batch-to-batch performance and reagent manufacturing operations.
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 the raising and investigation of non-conformances, lead investigations, and corrective actions.
  • Technically review completed process documentation and reports, and provide feedback to team members.
Requirements

We are looking for a degree-level qualified or equivalent individual with experience in a science subject, or equivalent relevant work experience. You should have experience of validation activities and operating within a GLP manufacturing laboratory environment, as well as line management experience. You should also have detailed knowledge and experience of high-volume, commercial immunoassay manufacture and testing, and be proficient in computer literacy, data analysis interpretation, and good attention to detail.

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