Production Scientist
1 month ago
LEX Diagnostics is currently hiring for a highly motivated and skilled Production Scientist to become part of our production team. Reporting directly to the Senior Production Scientist, you will play a pivotal role in the manufacture and quality control of the LEX molecular reagents.
LEX Diagnostics is an ambitious, well-funded point-of-care diagnostics business. We believe that fast, accessible molecular diagnostics will have a fundamental impact on how infectious diseases are managed at point of care and beyond. Our technology is uniquely able to address this challenge and we are commercialising it with partners who share our ambition. You can read more about LEX here.
As a production scientist at LEX, your role will also involve supporting the development of quality control (QC) and validation protocols. You will have the opportunity to contribute to wider laboratory activities, including stock control, while working closely with the team to establish and execute quality control protocols to ensure that our products meet regulatory standards. This is an exciting opportunity to make a significant impact on the future of diagnostics and work in a collaborative and innovative environment.
Responsibilities include:
- Support the production of LEX molecular biology reagents, including reagent preparation, lyophilization, and quality control of small to medium scale reagent batches.
- Ensure incoming reagents and chemicals are received, aliquoted, stored with documentation and uploaded to the Quality Management System (QMS) as required.
- Support production scaling activities in-house and with CMO’s.
- Support the creation and implementation of QC and validation protocols, ensuring adherence to regulatory requirements.
- Monitor and report on QC pass/fail metrics.
- Follow all requirements of working in an ISO 13485/FDA regulated environment.
- Document all production activities, following standard operating procedures (SOPs) and maintaining accurate records.
Requirements
The following skills and experience are required for success in this role:
- Batchelors degree in Molecular Biology or similar (or equivalent experience).
- Previous experience in production & or QC for In Vitro Diagnostic (IVD) devices and or reagents within an ISO13485/FDA regulated environment.
- Experience working in commercial or accredited biological laboratories.
- Proficiency in RT-PCR and other molecular biology methodologies.
- Experience working under a Quality Management System (QMS) is highly desirable.
- Excellent attention to detail, organisational skills, and ability to work in a fast-paced, deadline-driven environment.
- Strong communication skills and ability to collaborate with multidisciplinary teams.
Benefits
LEX Diagnostics is part of TTP Group, an employee-owned business. It operates from green surroundings in Melbourn, less than 10 miles south of Cambridge. TTP Group takes a long-term approach to investment and has been at the forefront of point-of-care diagnostics for over 20 years. Drawing upon the expertise of its consultants in the Life Science sector, and the management experience of a company with a 30-year track record of developing breakthrough technology and creating ambitious tech businesses, TTP Group invested core IP and staff into LEX in 2020.
Our benefits include
- Annual profit-related bonus
- Employer pension contribution of 12% of pensionable pay
- Private medical insurance for employees and dependants
- Free lunch and all-day refreshments
- Life insurance worth 6 x salary
- 25 days holiday with the option to carry over or bring forward 5 days
- Enhanced maternity and paternity leave, with the option to return part-time for a year
- Electric car leasing scheme
- Cycle to work scheme
- Public Transport Season ticket loan
- A wide range of social clubs and activities including squash, Zumba, yoga, arts and crafts and even our own rock band
- Local sports facilities and theatre discounts and memberships as well as our own onsite gym to use
This is an exciting opportunity within the LEX Diagnostics team and to help and support us with achieving our goal to commercialisation. If you’re looking to join a diverse and growing team, then apply now
Closing date 28th of May at which point we will respond to applications. Every application will receive a response.
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