Description

Reponsible for conducting and/or managing scientific research or quality testing performed in a laboartory environment including:

•Setting up, configuring, checking safety, installing, and maintaining laboratory equipment

•Planning, designing, conducting or following procedures within laboratory experiments to test the physical and/or chemical specifications of various substances, materials, and products to inform scientific research

•Estimating the resources and time required to conduct an experiment and monitoring performance to ensure these targets are met

•Collecting, preparing, and testing samples and recording observations

•Compiling research data and reporting results including with recommendations, applications, and conclusions

•Ensuring experiments and analyses are conducted within budgets and according to established scientific standards

•Researching, evaluating, and recommending investments in technology, equipment, systems, or other assets that will enhance the laboratory’s performance

To perform physical and analytical stability testing on existing and new medical devices and skin care products according to pre-determined stability study protocols, SOPs, OCIs and TDs in support of product shelf-life and product labelling.

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 Convatec 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

Key Responsibilities:

• Analysing, documenting, interpreting, and reporting laboratory data for stability studies to GMP/GLP standards.

• Support maintenance, calibration, documentation and updating quality records for Stability equipment.

• Maintain compliance to ISO13485 & ISO9001 standards in accordance with GLP/GMP compliant procedures.

• Provide technical knowledge to some stability studies with support from Senior Scientist.

• Experience with a wide range of analytical equipment such as balances and pipettes through to HPLC and ICP-MS.

• Write shelf-life plans/reports and stability protocols/reports with some support from Senior Scientist/Specialist.

• Performs Lab/OOS investigations with some supervision incorporating problem-solving and troubleshooting for future improvements.

• Identify when laboratory consumables, chemicals and reagents are low and request for reorder whilst continuously improving stock management.

• Perform the drafting of stability documentation such as protocols and reports.

• Write Quality documentation such as Change Control Records, Non-Conformances, and Out of Specifications.

• Ensure the Stability labs are maintained as a safe working environment, raising near misses where needed.

• Support planned and ad-hoc stability sample set-downs, pull requests and support laboratory tasks as and when required.

• Collation of stability data, including physical data retrieval, for stability/technical reports.

• Assist in the storage and retrieval of stability samples.

• Support any on-site maintenance, service and calibration activities performed by external vendors.

• Supports and provides information for internal and external audits where required in a timely manner.

• Coordination and organisation of studies from concept to completion including sample retrieval, as advised by senior team members.

• Suggest appropriate accelerated and real-time aging programmes that are suitable for the study in concept.

• Actively execute improvement ideas (Lean/6S) for the Stability laboratories and suite.

• Support improvements to current stability processes including updates to test and operating procedures.

• Train new and inexperienced members of staff in test procedures and related equipment calibration/use.

Skills & Experience:

• Preferably 1-2 years’ experience working in Medical Device/Pharmaceutical Industry within an R&D/product development role.

• Ability to react and respond positively to changes in priority and workload.

• Competent in following and adhering to pre-determined stability study protocols, SOPs, OCIs and TDs.

• Basic experience in the utilisation of computerised systems to manage data and information.

• An active team player disciplined in adhering to group objectives including taking an active role in team collaborative activities.

• Good working knowledge of Microsoft Office - specifically Word and Excel.

• Understanding of compliance with FDA and European Regulations (ICH), Quality Systems and GMP Guidelines.

• Proactive and positive mindset with an attitude that is open to change to embrace new ways of working and improvements.

• Competent in the disposal of chemicals, reagents and solvents in accordance to site and environmental procedures.

Qualifications/Education:

• B.Sc. or equivalent in a scientific discipline (e.g., Chemistry, Biology).

Working Conditions:

This position is based in Deeside (UK) working within an office and laboratory environment.

• Working in a laboratory environment with exposure to chemicals, reagents, and solvents.

• Working with various storage chambers (freezer, fridge, incubators etc.) for sample retrieval and deposit.

• Understanding of the role of stability testing within the product development lifecycle.

• Ability to adapt to a changing environment and balance multiple, competing priorities to meet objectives.

• Good working knowledge of laboratory Health and Safety Practices.

• Use of VDU equipment.