QC Process Team Leader - Bioassay

Title:

QC Process Team Leader - Bioassay

Company:

Ipsen Biopharm Ltd

Job Description:

Ipsen is a rapidly growing global biopharmaceutical company focused on innovation and specialty care. Our aim is to make a sustainable difference by significantly improving patients’ health and quality of life through differentiated and innovative medicines in oncology, neurosciences, and rare diseases. Ipsen Wrexham is a dynamic manufacturing plant with a strong culture of excellence and wellbeing, with a focus on taking our capability to the next level.

About the role

We are pleased to announce an excellent opportunity for a QC Process Team Leader – Bioassay, within our QC and Quality function due to internal mobility.

This position will lead and oversee the development of a highly adaptable, proficient, and customer-oriented team.

Responsibilities include delivering QC CBA testing and services within agreed timelines to support batch release.

The role also involves establishing and agreeing on Key Performance Indicators (KPIs) to monitor performance and identify opportunities for enhanced customer service. Furthermore, the position requires establishing and maintaining processes for the sustainable delivery of QC CBA testing services while driving continuous improvement in performance and service over the long term.

The QC Process Team Leader – Bioassay will serve as the main contact for communication and coordination with external CBA testing partners.

What you will be doing…

• Ensure all QC CBA data generated both internally and externally (at testing partners) is scheduled reviewed and reported within agreed business lead times.

• Maintain and manage the day-to-day relationship with external testing partners. Also, to maintain a holistic overview of all locations to ensure there is no divergence.

• Provide CBA support to Regulatory Submissions (including response to questions and post-marketing commitments) and Inspections

• Oversee and coordinate investigations in response to Out of Specification / Out of Trend results within company lead times.

• Maintain compliant documentation of associated QC CBA procedures, specifications and policies.

• Maintain all associated CBA equipment in a qualified, compliant state

• Trouble shoot assays and challenge ways of working to seek continuous improvement.

• Actively participate in internal and external audits/inspections.

• Establish highly effective working relationships with internal customers and stakeholders.

• Ensure training of individuals within team to maintain high level of expertise and skills provided.

• Develop technical skills of individuals to improve robustness, flexibility and efficiency of team.

• Recruit and manage personnel within team.

What are we looking for...

• Degree in Biology, Biochemistry or related scientific discipline

• Relevant experience working in a QC cell-based assay role

• Ability to assess different customer demands and make business priority calls to support batch release

• High Customer focus, with understanding of differing internal customer needs and timelines

• Strong people manager with the ability to motivate, empower and grow a team

• Detailed understanding of cell-based assay techniques, GMP and regulatory requirements (with relation to cell-based assay testing)

• Experience of working in a GMP Environment

Why Ipsen…

• We are a business that is experiencing exponential growth and transformation, therefore presenting a wide range of opportunities and challenges

• Major £multi-million investment in a New Drug Product Facility to increase the scale and capability of our Wrexham site, ultimately enhancing the products we develop for our customers and patients.

• 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 – 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 ‘Best Workplaces’ and ‘Best Workplaces for Wellbeing’ status in the Large Organisations category, as well as ‘Best Workplaces for Women’ in 2023.

• The pride of working for a company that directly impacts and changes lives for the better

If you feel that this could be the right next step for you, we would be delighted to engage with your application.

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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.