Company Overview
At FlexMedical Solutions (FMS), we help our customers bring their ideas to life and create a healthier tomorrow, by providing contract design, development, and manufacturing services to medical device OEMs.
In our role as a Contract Development and Manufacturing Organisation (CDMO), we focus on the disposable component of the medical device and have significant expertise with point of care (POC) in-vitro diagnostic (IVD) tests. Our in-house capabilities range from screen printing and laser ablation of electrodes for biosensors to final device assembly, including the formulation and deposition of chemistries.
Our modern facilities are based in Livingston, central Scotland, less than 20 minutes from Edinburgh and 40 minutes from Glasgow. Further growth means that we are now expanding our operations capabilities and have a requirement for a talented and experienced Senior Manufacturing Technician. With a healthy mixture of UK and international clients, we are a forward-looking organisation with an exciting future.
Role Description
As a Reagent Manufacturing Scientist, your role will be to oversee the production of reagents used in the fabrication of IVD products. You will work on both R&D and routine manufacturing projects where the finished diagnostic could help to diagnose a range of health related conditions, such as COVID-19, cancer or support a diabetic to manage their blood glucose level for example. Whatever the product or project, attention to detail and quality are paramount.
A key aspect of the role will be supervision of Manufacturing Technicians in support of the production of reagents.
Shift working may be a feature of this role.
Key Responsibilities
You will be responsible for:
- Manufacturing complex biochemical reagents from first principles for use in commercial IVD products
- In coming chemical raw material testing
- In process biochemical testing
- Reagent and biosensor release testing (such as calibration and QC)
- Utilising equipment such as pH meters, particle analysis systems, and ELISA plate readers
- Writing material specification and inputting into incoming test and in process tests
- Writing and following work instructions and standard operating procedures
- Completing and reviewing batch records and quality standards
- Initiating non-conformance reports as and when required
- Executing test protocols and generating and interpreting data
- Managing technicians where necessary
Knowledge, Skills and Experience required
Essential
- Degree in Organic Chemistry, Biochemistry or similar technical subject (consideration will be given to HND level qualified candidates able to demonstrate relevant similar role experience)
- Proven, demonstratable experience within a similar role in a regulated environment (such as diagnostics, medical devices or pharma
- Experience in calculating reagent formulations from first principles and building this into manufacturing documents
- Experienced in bioconjugation processes (solution or solid phase)
- Experience in operating complex lab equipment such as FPLC, HPLC, Flow cytometer, Plate readers
- Computer literate and highly proficient using Microsoft Excel and Microsoft Word
- Experience of writing reports and recording technical information accurately
- Experienced in conducting technical investigations and use of root cause analysis
- Be capable of performing repetitive tasks whilst retaining a high level of attention to detail
- Strong understanding of GMP requirements
- Supervisory experience.
Other Essential Requirement
-
Ability to work a flexible and rotating shift pattern if required.
Desirable
- Experienced in reagent process design and optimization
- Experience of transferring reagent designs from R&D into manufacturing
- Experience of defining reagent material specifications
- Experience of developing incoming test methods for critical chemical raw materials
- Experience of developing in-process test methods for biochemical reagents
- Experience in lab equipment calibration and maintenance.
- A working knowledge of ISO 13485 and FDA 21CFR part 820 – ideally within IVD manufacturing
- A conceptual understanding of data analysis in relation to reagent performance
- Experienced in process excellence tools (preferably trained to green belt level) would be advantageous.
Environment & Culture
FlexMedical Solutions is an evolving, scaling organisation operating in a highly regulated industry. The company is enjoying growth through success and is working on several leading-edge projects with exciting customers.
It is a changing environment that requires you to be very flexible and willing to learn and grow with the company. It is essential that you communicate with your colleagues and contribute to the company’s success. As a provider of sub-contract services, working for FlexMedical Solutions will bring a great deal of variety and excitement. Initiative is rewarded and personal development is a given.