Reagent Manufacturing Team Leader
LumiraDx is a medical technology company developing, manufacturing and marketing smart connected diagnostics and diagnostic-led care solutions. Founded in 2014 by entrepreneurs with a successful track record in building and scaling medical diagnostics and health IT businesses, the company has major operations in the UK and the USA, and is supported by a global sales network, LumiraDx is a high growth organisation. We have recently launched the innovative LumiraDx Platform, and are looking for proactive, experienced, focused and enthusiastic individuals who can make a significant contribution to the continued growth and success of our dynamic and forward-looking company.
Role & Responsibilities
This role could be based at our site in Stirling OR Motherwell, North Lanarkshire and travel between sites could be required.
The hours will be days initially but could move to shifts depending on business needs.
You will manage a team of technicians and scientists in a GMP environment responsible for the validation and transfer of new process and test methods from development into the manufacturing department. You will also provide support where required to manufacture and test reagents for commercial sale and related validation activities. You will be required to collaborate with the manufacturing shifts as well as the development transfer team. You will be responsible for and have people management and development responsibilities for Reagent Manufacturing Scientists and Analytical Scientists within the team and will report into the Reagent Manufacturing Manager.
- Plan and schedule all resources for validation activities as well as 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 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.
- Coordinate creation and appropriate review of Manufacturing SOPs, WIs and batch records
- Ensure full GMP, GDP and GLP compliance within the reagent manufacturing department.
- Facilitate creation and update of manufacturing SOPs, WIs 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.
- 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 skills.
- Experience of working with particle-based immunoassays and knowledge of the particle functionalisation chemistries.
- Working knowledge of electrochemical, fluorescent and particle analysis methods (including Flow Cytometry and Dynamic Light Scattering).
- Experience of working in the medical device sector.
- Knowledge and experience of working within a biohazard environment.
- Experience in statistical analysis techniques.
- Six Sigma Green Belt or Black Belt Qualification.
- Degree level qualified, or equivalent, in a science subject.
At LumiraDx, diversity and inclusion are part of who we are. LumiraDx is committed to inclusion across race, colour, religion, age, gender, sexual orientation or identity. We celebrate uniqueness and believe diversity drives innovation. LumiraDx seeks to deliver high quality, affordable medical diagnostics and healthcare services accessible to everyone around the world, and we wish to reflect a global multi-cultural approach across our business
Please note, if you wish to submit an application for this role, please consider the following information
This vacancy is open to internal and external candidates. If you are an internal candidate, please notify your line manager before you submit your application. If you’re successful, you may be subject to all or some of the LumiraDx standard pre-employment checks.
Criminal records data is processed as part of our recruitment and selection processes and, where necessary, in the course of employment, we verify that candidates are suitable for employment or continued employment to comply with legal and regulatory obligations to which the company is subject.
LumiraDx place a high level of importance on its responsibilities for information security and privacy and have put in place an information security management system to ensure that the company and its staff maintain the highest standards with respect to data protection and information security. All staff are responsible for information security and therefore must understand and comply with the Company information security policies, procedures and guidance.
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