Analytical Bio Project Principal Scientist

Analytical Bio Project Principal Scientist Department: GTD Global Technical Development Business Area: R&D, Pharmacovigilance & Regulatory Affairs Job Type: Direct Employee Contract Type: Permanent Location: Parma, IT About us Based in Parma, Italy, Chiesi is an international research‐focused pharmaceutical and healthcare group with 90 years' experience, operating in 31 countries with more than 7,000 employees (Chiesi Group). To achieve its mission of improving people's quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas: Discover more here. We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification , a recognition of high social and environmental standards . We are a reliable company that adopts and promotes a transparent and ethical behavior at all levels. We believe that the success of Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors . Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors. In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities. Chiesi Research & Development Our R&D team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management. Headquartered in the new purpose‐built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden), Toronto (Canada) and Shanghai (China). Purpose Accountable for analytical development, validation and transfer of methods as well as characterization of biotechnology derived products. Collaborate closely with internal experts and external CDMO partners. Tasks will range from early‐phase method development to late‐stage analytical support of product approaching market approval. Main Responsibilities Develop and validate analytical methods in collaboration with CDMO. Biological characterization of recombinant proteins in collaboration with relevant CROs. Write protocols, reports, SOPs and technical documentation. Provide expert analytical support in cross‐functional projects and workstreams. Ensure all work is performed in accordance with industry standards, guidelines and regulatory requirements. Ensure appropriate reporting and documentation of activities and project progression. Provide technical and science‐based solutions to projects. Support regulatory documentation and contribute to quality assurance. Experience Required At least 5 years' experience in the biotechnology industry. Extensive expertise within protein analysis and characterization. Experience in development, validation and transfer of analytical methods. Experience in Bioassay method development and validation is valuable. Experience from regulatory controlled work/processes. Broad general experience in adjacent fields for the development of biopharmaceuticals. Education Degree in Analytical Chemistry, Biotechnology or similar. Languages Strong written and spoken English. Soft Skills Analytical skills Planning and organizational skills Problem solving Quality orientation What we offer You would join a dynamic, fast‐growing, challenging and friendly environment. In Chiesi we firmly believe that our people are our most valuable asset, that is why we invest in continuous training, learning and development. We strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and collective well‐being. We want our people to come to work happy every day, and we know how important it is to find the right work‐life balance in order to be able to give our best. That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people‐care services. J-18808-Ljbffr