Job ref: MC101024 Job type: Permanent Location: Newry Closing date: Friday 25 Oct 2024 17:00 Support development of new veterinary pharmaceutical dosage forms particularly at the pre-formulation stage and assessing material changes post approval. Working in a diverse team of scientists developing a wide range of Pharmaceutical Dosage Forms including but not limited to, oral tablets, suspensions and solutions, sterile injectable suspensions and solutions, topical suspensions and solutions, and intra-mammary preparations. Employ quality by design principles whilst adhering to the quality standards outlined in VICH Guidelines and the relevant requirements set by regulatory bodies globally. Main Activities/Tasks Drive the evaluation of materials for new/alternative sources of Active ingredients/Excipients by designing appropriate investigations and testing experimental trials and risk assessment. Review relevant literature, including Certificates of Analysis, DMF, specifications, Identify appropriate Critical Material Attributes. Understanding functionally related characteristics (FRC's) of material and how they influence drug product, to support formulation development, and life cycle management. Develop test methods, perform chemical and physical testing on API's and excipients Support root cause investigations related to materials and perform laboratory analysis as required. Design and complete required protocols and reports Preparation and support of submission documents and regulatory response in consideration of (V) ICH guidelines, Ph. Eur., BP monographs and appropriate guidance documents were relevant such as CDER Ensure all equipment is adequately maintained and to carry out qualification, cleaning and calibration of equipment as required. Preparation and maintenance of Standard Operating Procedures (SOPs), ensuring SOPs are being adhered to at all times. Maintain clean and safe working environment within the laboratories, following all COSHH and other Health and Safety requirements Maintain an awareness of current trends and techniques in relevant Materials Science Liaise across Pharmaceutical development, R&D and partner groups in Operations and QC to effectively progress new product development and continuous improvement initiatives. Any other duties as deemed necessary by management Essential Criteria: Bachelor's Degree in Pharmaceutical Science, Chemical Engineering, Material Science or Chemistry is required. Relevant experience with sound fundamental knowledge of pharmaceutical material science. Minimum 3 years relevant experience, post undergraduate qualification, in industry or academia. Excellent hands on experimental and analytical skills including techniques such as FTIR, XRD, microscopy, Texture analyser, Rheometer, Particle Sizing Equipment and Thermal analysis. Excellent computer skills including Microsoft Office suite in particular ability to trend data using an appropriate statistical package e.g. Minitab, Excel Enthusiastic and hard-working individual, highly motivated to achieve technical targets with ability to multitask. Strong problem solving, critical thinking and technical skills Strong communication with effective teamwork skills. Desirable Criteria: Post graduate qualification in relevant area Working knowledge of GMP and (V)ICH requirements Evidence of material characterisation and its use to advance product development. Experience of supporting US and EU regulatory submissions. Experience of Quality by Design. Ability to critically assess scientific literature Additional Information: Applicants should be able to provide proof that they have a right to work in the UK at the time of their application. Applicants who are unable to provide this proof will not be considered. We regret that applications received after the closing date and time will not be accepted. To Apply Please forward your CV via the APPLY Now button below.