Our search for better is changing the lives of our customers. It’s changing the careers of our people too – creating new challenges and opportunities all the time. We’re a business that never stands still. Join us on our journey to #ForeverCaring as a Team Lead, Stability – Laboratory Services, and you won’t either.
As a Team Lead Stability – Laboratory Services, you will ensure that physical and analytical stability testing is performed on existing and new medical devices according to pre-determined stability study protocols, SOPs, OCIs, TDs and regulated standards/quality systems (ISO 13485, ICH Guidelines, 21CFR820) in support of product shelf life and product labelling.
Key Responsibilities
Responsible for a small team of people, which may be direct reports, overseeing daily laboratory operations, coordination of studies and sample management processes.
Analyze, document, interpret and report laboratory data for stability studies to GMP/GLP standards.
Support maintenance, calibration, documentation and updating quality records for Stability equipment.
Maintain and review compliance to ISO13485/ISO9001 standards in accordance with GLP/GMP compliant procedures.
Provide technical and Subject Matter Expertise (SME) for all stability studies to support product shelf-life.
Troubleshoot a wide range of analytical equipment such as balances and pipettes through to HPLC and ICP-MS.
Lead Lab/OOS investigations with no supervision incorporating problem-solving and troubleshooting for future improvements.
Write and review quality documentation such as Change Control Records, Nonconformance's and Out of Specifications.
Advise and suggest stability study design in Shelf-Life Plans and Protocols to support shelf-life in different markets.
Actively develop leadership skills to enable key business decisions regarding all aspects of Stability.
Actively monitor the working environment of Stability labs to ensure high levels of safety.
Organize stability samples across multiple storage conditions over two local sites.
Collation of stability data, including physical data retrieval, for stability/technical reports.
Provide management expertise and advice to the Stability/Project/R&D Teams on all Stability-related matters.
Support and liaise with any on-site maintenance, service and calibration activities performed by external vendors.
Attend and act as Subject SME for internal and external audits where required.
Design and review appropriate accelerated and real-time aging programmes.
Actively suggest improvement ideas (Lean/6S) for the Stability laboratories and suite.
Lead improvements to current stability processes including updates to test and operating procedures.
Actively lead any activities that help maintain, or improve, staff engagement and morale.
Support with the generation of KPIs and suggest ways to enhance team performance and compliance.
Train new and inexperienced members of staff in test procedures and related equipment calibration/use.
Provide the necessary mentorship and guidance for development of high performing individuals within the team.
Skills & Experience
3-4 years’ experience working in Medical Device/Pharmaceutical Industry within an R&D/product development role preferred.
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 utilization of computerized systems to manage data and information.
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.
Ability to communicate effectively and cross-functionally to ensure the business needs are met.
Ability to successfully lead and shape the stability team and develop individuals where necessary.
Qualifications/Education
M.Sc. or equivalent experience in a scientific discipline (e.g., Chemistry, Biology).
Languages
English (speaking, reading and writing)
Working Conditions
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.
Our progress will give you countless opportunities to move forward too. Seek out new challenges, and you’ll find them. Stretch your thinking, and you’ll find new ways to make an impact. And if you embrace the opportunity to drive your own growth, you could go further, and achieve more, than ever before.
This is a big step forward.
This is work that’ll move you.
#LI-AC2
#LI-Onsite
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