Title: Pharmaceutical Process Technician (PPT) - LANT 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. As we look to progress one of our key product lines from clinical phase manufacturing through to commercial manufacturing, we now have a great opportunity for someone to join us as a Pharmaceutical Process Technician to support the delivery of that process and be involved at a pivotal stage in the product lifecycle. The role will require someone with experience in a GMP/cleanroom environment, and ideally with a relevant academic study, therefore we do think this role could appeal to a Graduate. What will you be doing… Develop technical understanding and operational knowledge/expertise in all aspects of the drug substance API manufacturing process and equipment. Ensure all training is kept up to date and documented by adhering to training plan requirements, ensuring that you do not perform any tasks you are not trained to complete. Perform all manufacturing operations including but not limited to: Component transfer and preparation. Cleaning of equipment and cleanroom. Media preparation processes. Upstream processes e.g. Bioreactor vessel assembly, cell fermentation processes using bioreactor systems, cell culture harvesting, culture centrifugation and cell pellet resuspension. Downstream processes e.g. Cell lysate flocculation, capture chromatography, polishing. chromatography, protein activation, tangential flow filtration. DS vial filling Apply excellent attention to detail, assisting in the maintenance and updates of production area documentation within the QMS as required. Work co-operatively to ensure good teamwork, demonstrating effective communication & collaboration skills. Ensure compliance with all EHS policies and procedures. Work in a safe manner at all times and raise any Health and Safety concerns to your line manager or EHS team. Strive to achieve process excellence, in a proactive manner, by participating in process monitoring and continuous improvements projects. Assist with Quality and safety audits as required. Play an operational and integral part in site processes; Unplanned Events and other Investigations (OOS/Complaints), Corrective/Preventive Actions (CAPA), Change Control. What are we looking for… Strong attention to detail, and the ability to execute actions as per written instructions. Excellent interpersonal skills, organised and enthusiastic to learn new skills. Experience of working in accordance with SOPs and ensuring GDP and data integrity maintenance are at the forefront of all work executed. Experience manufacturing within cleanroom manufacturing environment (ISO7- ISO5) Able to perform under pressure to competing demands and stakeholders, strong customer focus. Awareness of materials management systems in a cGMP environment i.e SAP. Results driven and willing to take initiative. Methodical approach to process execution and target driven. Flexibility and willingness to support change is a key requirement of this position as the company grows and evolves. Experience working in a cell manufacturing facility to standards of GMP (desirable). Experience working with cell culturing manufacturing equipment i.e protein purification systems, tangential flow filtration systems, bioreactors for fermentation (desirable) Understanding of Lean Manufacturing principles and the application of 5S (desirable) Experience with ISO13485 QMS (desirable) 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 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.