Job Description

Title: Process Support Specialist

Company: Ipsen Biopharm Ltd

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Ipsen is a growing and dynamic specialty-driven biopharmaceutical company focussed on innovation and specialty care.

The patient is at the heart of everything we do, and we also care for our employees because they are the ambassadors who truly make a difference. We attract and develop bold, agile and entrepreneurial individuals who take full ownership of their decisions, leaders drawn by a purpose to make a direct impact through their work in people\xe2\x80\x99s lives, all of which is underpinned by our Ipsen Way of Being.

Following an internal promotion, we are now looking for a QC Process Support Specialist to join our team here in Wrexham.

As QC Process Support Specialist, your role will be to evaluate and apply protocols and methods to inspect and test in-process raw materials and finished products, ensuring that they are in compliance with internal and external safety, quality and regulatory standard requirements for distribution.

Key responsibilities\xe2\x80\xa6

• Point of contact for technical support for QC Microbiology team providing technical knowledge and resolving technical issues associated with QC testing.
• Work in collaboration with Biologics Development to ensure methods remain in a validated state and are capable and robust.
• Lead and coordinate out of specification and out of trend results, unplanned event investigations and change controls in accordance with current procedures and company lead times.
• Review and report QC Microbiology data in line with company lead times.
• Coordination of reviews of laboratory methods and validation documents against pharmacopoeia and licence requirements to ensure ongoing compliance.
• Maintain and coordinate data review and trending processes in Novatek.
• Coordinate and investigate out of trends and drive process improvements.
• Coordinate departmental training to ensure a sufficient pool of expertise and skills exist to meet business needs.
• Lead and support QC related projects in line with company lead times.
• Represent QC in audits/inspections as subject matter expert for key activities related to microbiological testing and perform internal inspections within the QC Microbiology department to ensure ongoing compliance and implement improvements.
• Actively troubleshoot and challenge ways of working to seek continuous improvement and keep abreast of new technologies in order to increase efficiency and maintain GMP compliance.
• Ensure all routine microbiological sampling, testing, Environmental Monitoring (EM) and other routine laboratory activities are performed in accordance with standard operating procedures.
• Ensure all work is carried out in a safe manner.
• Support CBA activities as required.

What we\xe2\x80\x99re looking for\xe2\x80\xa6

• Qualified in to degree level or equivalent in a Biological Science subject, preferably Microbiology
• Previous experience working in a pharmaceutical microbiology laboratory
• Knowledge of US/EU cGMPs as applied to Biopharmaceutical testing and application
• A willingness to learn and develop with the support of Ipsen
• Flexible and agile approach to work
• Excellent team player

Why Ipsen\xe2\x80\xa6

• We are a business that is experiencing exponential growth and change, therefore presenting a wide range of opportunities and challenges, particularly here at our Wrexham site
• A fantastic culture and working environment with many long-serving employees
• Huge commitment to Diversity & Inclusion - almost 50% of our top 160 leaders are women
• A genuine focus on the environment and sustainability \xe2\x80\x93 our Wrexham site is powered by 100% renewable electricity
• Competitive salaries and enhanced benefits package which includes annual bonus, generous pension scheme, wellness allowance and so much more.
• Awarded \xe2\x80\x98Best Workplaces\xe2\x80\x99 and \xe2\x80\x98Best Workplaces for Wellbeing\xe2\x80\x99 status in the Large Organisations category for 2023
• The pride of working for a company that directly impacts and changes lives for the better

To all agencies: please no phone calls or emails to any employee of Ipsen in relation to this opening. All resumes submitted by search firms/employment agencies to any employee at Ipsen via email or any form of communication/method will be deemed the sole property of Ipsen, unless such search firms/employment agencies were engaged by Ipsen for this position and a valid agreement with Ipsen is in place. In the event a candidate who was submitted outside of the Ipsen agency engagement process is hired, no fee or payment of any kind will be paid.

IPSEN is committed to equality of opportunity for all staff and applications, individuals are encouraged to apply regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.

Ipsen