QC Microbiologist 2

Ipsen

  • Wrexham
  • Permanent
  • Full-time
  • 13 days ago
Title: QC Microbiologist 2Company: Ipsen Biopharm LtdJob Description: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’s lives, all of which is underpinned by our Ipsen Way of Being.Our site in Wrexham continues to flourish, and as we prepare for an increased volume and demand for our products, we naturally need to build our teams to ensure we are ready to meet those requirements.This is a newly created position for a QC Microbiologist 2 to increase capability within our NDP portfolio. In this role you will be responsible for ensuring that all applications, system products and projects meet defined quality standards. Furthermore you will be tasked with developing, conducting and evaluating application audits and testing processes.What will you be doing...
  • Perform environmental Monitoring of NDP Clean Rooms and controlled environments in accordance with current testing schedules and manufacturing activities in addition to supporting other facilities.
  • Perform microbiological testing of raw materials, in-process and final product for microbial contamination within required time frames for the NDP facility and provide support as directed for other facilities.
  • Identify and initiate out of specification and out of trend results, unplanned event investigations and change controls in accordance with current procedures in support of the NDP facility.
  • Provide training in all key microbiological methodologies.
  • Initiate and drive microbiological investigations through to completion.
  • Represent QC on the NDP project teams and in meetings and provide microbiological expertise.
  • Be proficient in reviewing lab methods against current pharmacopoeia and licence requirements to ensure ongoing compliance.
  • Lead QC related projects e.g. process improvements.
  • Responsible for completion of batch data and all associated OOS/OOT and UE records for designated batches.
  • Support real time process walks within the NDP manufacturing area in accordance with site procedure.
What we're looking for...
  • Qualified to degree level or equivalent in a Biological Science subject, preference towards Microbiology
  • Previous experience working in a pharmaceutical microbiological laboratory
  • Knowledge of aseptic techniques, US/EU cGMP's
  • Excellent team player
  • Flexible and agile to meet the evolving requirements of the customer/business
  • Appreciation and interest in process improvement and efficiencies
  • Genuine passion for Quality and understands the impact and importance within a pharmaceutical environment
Why choose Ipsen...
  • We are a business that is experiencing exponential growth and change, 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
  • 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
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