Technical & Scientific Affairs Scientist

Technical & Scientific Affairs ScientistSligoBiotech manufacturingHave you ever wondered what it is like to work in a Biotech before it goes into full scale production? Well this could just be the role for you.They are small at present but have a massive global presence in the biotech space, they are growing out their site in Sligo and are looking to add another TS&A Scientist to the team. They have already been recognised as a great place to work and the future looks extremely bright for hidden gem in Sligo. Having met with them, they offer you a chance to add some career defining experience to your cv.Desired experience for this role.·At least 3 years’ experience in the biotechnology and/or pharmaceutical industry, with Operational experience of new product introductions, scale-up, validation and product support in a GMP environment. ·Knowledge of the processes and equipment necessary for the manufacture of pharmaceuticals (oral solid dose), parenterals and/or biologicals.·Experience in authoring, review and execution of process validation studies and reports is a must.·Experience with vaccines would be preferable particularly in the area of product development and stewardship.·Experience in cleaning validation is desirable.Responsibilities·The Technical and Scientific Affairs (T&SA) Scientist is a problem solver that will play an integral role in the execution of new-product transfer activities such as engineering runs and process validations between manufacturing sites, along with continuous development of existing products at the site.·Provide technical and scientific support to the Operations Department through personnel training of processes.·Be involved in the development and implementation of supporting activities such as new-process and cleaning validations, including associated documentation such as batch records, cleaning protocols and reports.·Continuously monitor and support manufacturing processes including leading of process optimization (preemptive) through introduction of statistically based tracking matrixes and root cause investigation (reactive) as required in order to drive product improvement and quality.·Raise, investigate, and close out non-conformances, planned deviations and change control requests as required.·Where required perform sample analysis in the laboratory in accordance with standard operating procedures (SOPs).·This role will require extensive cross-functional collaboration with various departments such as Manufacturing, Quality, Engineering, Finance and Regulatory Affairs.·This is a day shift role Monday to Friday.For a confidential chat, please reach out to