Senior Team Leader, Reagent Manufacturing
2 weeks ago
Job Description
Responsible for ensuring delivery of validated assays into the manufacturing department that achieve the consistently high quality required for progression to Production and that meet the Design for Manufacture requirements. Responsible for the routine manufacture of validated assays to meet production timelines through the management of day-to-day activities and performance of the multiple department Teams. You will be responsible for ensuring a validated manufacturing environment is maintained and oversee investigations and process improvement opportunities. You will have people management and development responsibilities for a Team of technicians and scientists.
You will manage a team of technicians and scientists in a GMP environment responsible for manufacture of reagents for commercial sale and related validation activities. Also responsible for transfer of new processes and test methods from development into the manufacturing department. Manufactured reagents will be used to produce test strip devices for a wide range of assays on the LumiraDx platform. You will be responsible for Scientists and Technicians as direct reports within a designated team and will report into the Manager, Reagent Manufacturing.
Experience of validation activities and operating within a GLP manufacturing laboratory environment. Line management experience Detailed knowledge and experience of high volume, commercial immunoassay (or similar) manufacture and testing. Good at troubleshooting and identifying and implementing control procedures and process improvements Computer literacy, data analysis interpretation skills and good attention to detail Effective communicator and motivator - good people development skillsResponsibilities
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 which will meet all reagent and strip production needs. Ensure creation of appropriate validation documentation and protocols in collaboration with supporting departments, in particular QA and Product Assurance Facilitate purchase of suitable equipment for the manufacture and testing of reagents including the creation of related documentation, service contracts and validation activities required for use. Ensure new raw material and consumable availability for newly introduced processes and timely upload of real time material and labour data into ERP system 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 analyse appropriate experiments for assessing and improving batch to batch performance and reagent manufacturing operations in general.Quality/Regulatory Compliance
Ensure full GMP, GDP and GLP compliance within the reagent manufacturing department. Coordinate creation, update and appropriate review of manufacturing SOPs, WIs, BRs and protocols and provide technical review. Follow and comply with all relevant internal quality and H&S processes and procedures and ensure compliance within the reagent manufacturing department. Support and monitor raising and investigation of Non-conformances, lead investigations and corrective actions and support other team members. Technically review completed process documentation and reports, and provide feedback to team members to support a Right First-Time culture
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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