Team Lead Stability Laboratory Services Fixed Term

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 around 10000 colleagues we provide our products and services in almost 100 countries united by a promise to be forever caring. Our solutions provide a range of benefits from infection prevention and protection of atrisk skin to improved patient outcomes and reduced care costs. Group revenues in 2023 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE : CTEC). To learn more about Convatec please visit

Our search for better is changing the lives of our customers. Its changing the careers of our people too creating new challenges and opportunities all the time. Were a business that never stands still. Join us on our journey to #ForeverCaring as a Team Lead Stability Laboratory Services and you wont 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 predetermined 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 shelflife.

Troubleshoot a wide range of analytical equipment such as balances and pipettes through to HPLC and ICPMS.

Lead Lab / OOS investigations with no supervision incorporating problemsolving and troubleshooting for future improvements.

Write and review quality documentation such as Change Control Records Nonconformances and Out of Specifications.

Advise and suggest stability study design in ShelfLife Plans and Protocols to support shelflife 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 Stabilityrelated matters.

Support and liaise with any onsite 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 realtime 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

34 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 predetermined 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 crossfunctionally to ensure the business needs are met.

Ability to successfully lead and shape the stability team and develop individuals where necessary.

Qualifications / Education

• 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 youll find them. Stretch your thinking and youll 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 thatll move you.

LIAC2

LIOnsite

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A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.

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Equal opportunities

Convatec 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.

Notice to Agency and Search Firm Representatives

Convatec is not accepting unsolicited resumes from agencies and / or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and / or search firm without a valid written and signed search agreement will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Already a Convatec employee

If you are an active employee at Convatec please do not apply here. Go to the Career Worklet on your Workday home page and View Convatec Internal Career Site Find Jobs. Thank you!

Key Skills

Law Enforcement,ABB,Marine Biology,Filing,Automobile,AV

Employment Type : Full-Time

Experience : years

Vacancy : 1