Manufacturing Operations Manager, Reagent Production

2 months ago

Alloa, Clackmannanshire, United Kingdom LumiraDx Full time
Job Description

Key Responsibilities

  • Ensure 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 and process improvement opportunities.
  • Lead a team of technicians and scientists in a GMP environment, responsible for manufacture of reagents for commercial sale and related validation activities.
  • Transfer new processes and test methods from development into the manufacturing department.

Requirements

  • Experience in 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, with ability to identify and implement control procedures and process improvements.
  • Computer literacy, data analysis interpretation skills, and good attention to detail.
  • Effective communication and motivation skills, with ability to develop people.

Key Performance Indicators

  • Plan and schedule all resources for validation activities and reagent manufacture and testing to ensure supply of reagent materials in line with strip production requirements.
  • Provide 'voice of customer' input and work in conjunction 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 associated with reagent manufacture are sufficiently mitigated/controlled.
  • Ensure the reagent manufacturing processes and associated testing on shift are carried out safely and efficiently.
  • Provide input to validation plans for equipment, processes, and test methods for the department.
  • Design, execute, and analyze appropriate experiments for assessing and improving batch to batch performance and reagent manufacturing operations.

Quality/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, lead investigations, and corrective actions.
  • Technically review completed process documentation and reports, and provide feedback to team members.

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