Analytical Development Scientist -Associate Director
MSD
Carlow
Analytical Development Scientist -Associate Director Are you MSD Carlow’s next Analytical Development Scientist? We have a newly created opportunity to join our Technical Operations team, if successful you will be responsible for implementing the site Data Integrity strategy and associated global compliance requirements. What you will do? Bring high standards, knowledge, creativity and leadership to carry out the following: This role has responsibility for all aspect of analytical support through development, clinical and commercial stage of new Drug Products. Including method development and validation, testing of clinical materials and support to launch of the product, commercial analytical support for signification deviation in release and/or stability testing at local site. You will also support improvement initiatives in any area of the analytical development business. Be a key support for signification deviation in release and/or stability testing at Carlow site. Lead the development and optimization of reliable, validated, analytical methods to characterize the quality attributes of drug substances and products for all projects supported by the site. You will provide the analytical CMC information for filings and responses to queries from worldwide regulatory agencies in connection with this information to support marketing approvals. You will ensure compliance with company, global and regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions. Ideally you would have maintained collaborative contacts in the scientific community, universities, government and other outside laboratories in relation to analytical chemistry. Monitor industry trends, new technology initiatives and worldwide analytical regulatory guidance. What skills you will need: In order to excel in this role, you will more than likely have: A MSc and preferably PhD in Biochemistry or a related field. Several years’ experience in analytical biochemistry or associated disciplines, ideally in a manufacturing, preferably GMP setting with experience as a senior scientist/analyst. BSc will be considered if you have 5+ years of experience as an analytical scientist or similar role in biopharmaceutical industrial and 2 years’ experience as a senior scientist/analyst, ideally in a GMP manufacturing setting. Knowledge of bioanalytical methods including, HPLC/UPLC, SEC, IEX, CE, ELISA etc. Troubleshooting and maintaining process instrumentation and equipment. Laboratory Quality Systems. Demonstrable analytical and systematic problem -solving skills. Project management skills. As a company, we are committed to ‘Inventing for Life’ in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. So, if you are ready to: Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.
1116 days ago