Title: QC Bioassay Associate Company: Ipsen Biopharm Ltd Job 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. The role of the QC Bioassay Associate is to evaluate and apply the relevant protocols and methods needed to inspect and test in-process raw materials and finished products, ensuring they are in compliance with the internal and external safety, quality and regulatory standards requirements for distribution. Key responsibilities… Perform routine tissue culture activities using aseptic technique to ensure consistent delivery of cells for use in bioassay testing. Perform bioassays that appropriately reflect product mode-of-action, in support of batch release and non-routine work requests. Entry of results into LIMS systems and trending database as required. Use of bioassay statistical packages to appropriately analyse data, and applying basic understanding of bioassay principles (parallelism, similarity) to assess data against assay system suitability criteria Preparation of media and other reagents ready for use in bioassay testing/ tissue culture activities Performing reviews on internal and external data packs ensuring data is delivered according to site systems, GLP, cGMP and regulatory requirements Participate in the generation/update of SOP's, investigations, nonconformances, validation protocols, reports, method validations Support analysis of customer complaint samples when required Maintain laboratory equipment, ensuring weekly/monthly checks are completed if appropriate Support laboratory equipment projects e.g. procurement, installation, validation and decommissioning Participate in internal/external audits/inspections where required Support QC related projects e.g. Change Controls or other process improvements through to completion What we’re looking for… Experience working in a pharmaceutical laboratory Knowledge of GxP requirements and principles related to Quality Control laboratories Knowledge of basic bioassay principles desirable but not essential as full training will be offered Experience or understanding of aseptic techniques Ability to work independently according to established methods and SOPs to perform bioassay testing as required Experience of maintaining accurate records of laboratory work in either paper or electronic formats Basic understanding of cGMP requirements and relevant regulatory guidance for cell-based assay Good organisational and time management skills, able to adapt to rapidly changing priorities Communication skills –effective reporting and presentation of bioassay results to various audiences Why Ipsen… 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 – 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 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. se leave for the primary recruiter to complete 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.