Scientist II

Job Description

*[Employer hidden — view at passion-project.co.uk] has announced a major milestone in our R&D journey and commitment to our vision of pioneering trusted medical solutions to improve the lives we touch. We have unveiled plans to relocate the majority of our UK-based research and development (R&D) activities from Deeside to Manchester from late 2027/early 2028, alongside a significant expansion of our facilities in Boston. 

An exciting future in Manchester

The new, planned Manchester facility has the potential to be a major R&D hub in our global network which will initially function as the company’s global testing laboratories, with cutting-edge analytical R&D capabilities including quality control and materials, regulatory functions, and health innovation, positioning [Employer hidden] at the forefront of medical technology development. Our new state-of-the-art facilities will also strengthen our collaboration with Manchester’s vibrant life sciences ecosystem, which includes leading universities, hospitals, and research institutions*

Position Overview:

A Scientist II in the Physical Testing Department supports the product development process for medical devices. Scientist II’s should have good understanding of the important of physical testing in ensuring the safety, efficacy, and quality of medical devices. Scientists are responsible for conducting various tests and experiments to assess the physical properties of medical devices. Scientists will generate, document and analyse data in compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Documentation Practices (GDP). Scientist II’s should also be able to use their knowledge and experience to develop test methods based on recognised industry standards bespoke test methods that satisfy the requirements of our products. Scientists should be detail orientated, able to work on multiple projects and adapt to changes, with good problem-solving skills and strong communication are essential.

Key Responsibilities:

• Working within a controlled ISO 13485 and ISO 9001 laboratory quality system and in accordance with GxP procedures.
• Design, plan and execute Physical Testing in support of R&D activities and base business projects in accordance with applicable procedures and guidelines.
• Development and validation of new Physical Testing methods.
• Estimating the resources and time required to conduct an experiment and monitoring performance to ensure targets are met.
• Author validation protocols, reports and technical documents for medical devices/pharmaceutical products.
• Independently analyse and interpret data through statistical analysis.
• Prepare and present internal presentations to present findings of the laboratory.
• Effective organisation of assigned workload; ensures integrity of all data generated and timely/accurate provision of results to GLP standards.
• Accurate recording and analysis of laboratory data in accordance with good documentation practices.
• Perform detailed laboratory investigations to determine the root cause analysis of atypical and out of specification results, apply corrective and preventative actions and author concise investigation reports.
• Assist in laboratory test method/procedural revisions.
• Ensures laboratory compliance with cGMP regulations and SOP’s/TD’s.
• Involvement in change control activities and associated actions.
• Support laboratory daily activities such as laboratory housekeeping, equipment maintenance and calibration, solution preparation, consumable stock replenishment, shipping samples, scanning documentation, logging of samples etc.

Skills & Experience:

• 2-3 years experience in a working laboratory environment, with Medical Devices/Pharmaceutical Industry is preferred.
• Good written and verbal communication skills.
• Broad understanding of physical testing.
• Good working knowledge of Microsoft Office, specifically Word and Excel.
• Familiarity with safe working in a laboratory environment. Experience in a working laboratory environment, within Medical Devices/Pharmaceutical Industry is preferred.
• Working knowledge and understanding of compliance with FDA and European regulations relating to Quality Systems (ISO13485:2016, ISO9001:2000, FDA 21 CFR part 820) and GMP Guidelines and Regulation.
• A detailed understanding of common statistical analysis and experience with MiniTab desirable.

Qualifications/Education:

• Bachelor’s Degree in a relevant science-related discipline, i.e., biological sciences.

Working Conditions:

This position is based in Deeside (UK) working within an office and laboratory environment. This is an onsite position with the opportunity to occasionally remote work as an when agreed in advance with their manager.

• Working in a laboratory environment with exposure to biological agents, chemicals and reagents – Training will be provided.
• Competent in the disposal of chemicals and reagents in accordance with site and local environmental procedures – Training will be provided.
• Health and Safety at Work etc. Act 1974.
• The Management of Health and Safety at Work Regulations 1999.

Special Factors:

Flexibility of task management and working laboratory environment is essential due to continually changing priorities. [Employer hidden] is a multi-national company therefore some flexibility in hours is required due to working in an international company with colleagues in different time zones.

Ready to join us?

At [Employer hidden] we're pioneering trusted medical solutions to improve the lives we touch. If you're ready to make a real impact, apply today and help us bring our Forever Caring promise to life.

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[Employer hidden] provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.

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