Stability Scientist II

Overview

About Convatec
Convatec is a global medical products and technologies company focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With more than 10,000 colleagues, we operate in around 90 countries, united by a promise to be forever caring. Our solutions provide benefits such as infection prevention and protection of at-risk skin, improved patient outcomes, and reduced care costs.

Convatec’s revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:

CTEC). To learn more please visit

The role: 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.

• 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 ISO
  13485 & ISO
  9001 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.

• 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.

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

• Principal Contacts & Purpose of Contact:
  Laboratory Assistant, Scientist I, Senior Scientist, Team Leader, Laboratory Manager.
• Travel Requirements:
  There may be opportunities to attend external training courses which may involve daytime return travel or an overnight stay.
• Languages:
  
  Speaking:
  Yes English;
  Writing/Reading:
  Yes English.
• Working Conditions:
  
  Working in a laboratory environment with exposure to chemicals, reagents, and solvents; working with various storage chambers; understanding of stability testing within the product development lifecycle; ability to adapt to changing priorities; good laboratory Health and Safety practices.
• Special Factors:
  Flexibility of task management and working laboratory environment is essential due to continually changing priorities.
• Ready to join us?:
  At Convatec, we’re pioneering trusted medical…