Reagent - Production Manager
- Experience Level
Responsible for ensuring delivery of consistently high quality assay reagents through the management of day to day activities and performance of the reagent manufacturing team as well as the validation and implementation of new processes and test methods into the department.
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, one of the most high growth organisation in EU.
- Provide 'voice of customer' input to R&D to drive delivery of scalable, robust processes and test methods which will meet all reagent and strip production needs.
- Purchase suitable equipment for the manufacture and testing of reagents.
- Support FMEA and H&S risk assessment activity, to ensure all risks to product and people associated with reagent manufacture are sufficiently mitigated/controlled.
- Create and deliver of validation plans for equipment, processes and test methods for the department.
- Plan and schedule all resources for reagent manufacture and testing to ensure supply of reagent materials in line with strip production requirements.
- Ensure the reagent manufacturing processes and associated testing are carried out safely and efficiently.
- Create robust and practical Manufacturing SOPs, WIs and batch records and maintain all supporting documentation for the department.
- Design, execute and analyse appropriate experiments for assessing and improving batch to batch performance and reagent manufacturing operations in general.
- Degree level qualified in a science subject
- Experience of validation activities and operating within a GLP manufacturing laboratory environment.
- Detailed knowledge and experience of high volume, commercial immunoassay manufacture and testing.
- Good at troubleshooting and identifying and implementing control procedures and process improvements
- Able to write and execute clear and concise protocols for complex reagent manufacturing procedures (SOPs)
- Highly motivated individual that can demonstrate flexibility and a can do attitude.
- Ensures positive, productive and proactive relationships with a range of internal and external key stakeholders.
- Self driven, takes ownership and demonstrates high levels of personal accountability, and is motivated to complete the goals and objectives
- Can listen and present effectively, providing progress updates and feedback on a regular basis
- Ability to plan and organise work in accordance with the overall objectives and required timelines
- Demonstrates the ability to solve problems under conditions of uncertainty and ambiguity and is able to think strategically in times of pressure to drive toward the best solutions
- Able to travel between company sites as needed (not expected to be frequent)
Competitive Salary, bonus and career progression