Senior Technical Leader, GRD CMC

Job description

About us Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. Discover more here. At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact. Diversity and inclusion are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better. Chiesi Global Rare Diseases Chiesi Global Rare Diseases is a Chiesi Group’s business unit established in February 2020 and focused on research, development and commercialization of treatments and patient support services for rare and ultra-rare disorders, many of whom have limited or no treatments available. This unit is based in Boston, Massachusetts, with a strong synergy with the headquarters in Parma. Rare unit has a focus on research and product development for lysosomal storage diseases, rare hematology, ophthalmology disorders and rare immunodeficiencies. The unit is also a dedicated partner with global leaders in scientific research, patient advocacy and care. Discover more here . What we are looking for This is what you will do GRD Technical Leader is accountable for the budget, strategy and execution of CMC development and IMP supply of projects within the GRD portfolio from candidate nomination/selection to handover to manufacturing organisation for commercial launch. The CMC director hold the role of technical leader on the CT and the ETT. The CMC director can also hold the role of ETT workstream lead depending on the project deliverables. You will be responsible for Build the overall strategic development plan in collaboration with product CT. Strategy of the CMC development including IMP supply to meet the project milestones and long term business objectives. Drive execution of the CMC development plan in compliance with the regulatory strategy. Coordinate building of documentation package fit for development phase. Lead new business development opportunity evaluations with focus on CMC. Act as GRD CMC representative in project core team. Build and organize the ETT by sourcing the right internal and external competences according to project needs. Lead and manage external consultants. Lead the ETT based on the project scope and strategic development plan. Project budget accountability for CMC activities (CRO’s, CDMOs, main consultancy agreements etc). Act as subject matter expert in areas of competence Act as workstream lead depending on project requirements. Review the ETT workstreams development plans and align it with the overall strategic development plan. Providing technical support in scouting, auditing, and selection of CROs/CDMOs. Lead and manage long term relationships with academic partners/CRO/CDMOs for successful delivery of collaboration and outsourced projects with Chiesi values and shared value in mind. Provide technical review and approval, if needed and as seen fit, of relevant documentation to achieve proper quality for clinical trial applications and market approval applications Actively contribute and drive the development of the department in line with GRD and GRD R&D strategic goals. Disseminate technical knowledge and leadership skills within department and to relevant adjacent functions throughout Chiesi. You will need to have Minimum Master of Science in relevant field Minimum 10 years of relevant industrial experience from the pharmaceutical industry. Experience from development or manufacturing of drug substances, drug products or medical devices. Highly experienced in leading and managing internal and external activities, resources, and stakeholders. Experience from regulatory interactions with EMA and/or FDA and quality module 3 documentation and requirements. Experience from working with CMOs and CROs. Good knowledge regarding GMP compliance. Good knowledge of drug development framework including regulatory guidelines, best practices and industry standards Strong leadership and problem-solving skills. Good skills in written and verbal communication Project leader skills English - Fluent in verbal and written communication Normal to experienced user of MS office Broad general experience in the field of development and manufacturing of pharmaceuticals, including analytical development and testing (CGT, biologics and/or small molecules). Location Europe - Remote Compensation range The package outlined below is based on the role being located in Italy. Where the role is offered in a different country, the applicable salary, bonus and benefits will be aligned to the relevant local market and internal frameworks. Full details of the applicable package will be provided at the appropriate stage of the recruitment process. The minimum salary for this role is €68.480, aligned to our established salary framework. The final offer will reflect the candidate’s skills, experience, qualifications and internal equity considerations. This role is eligible to participate in an annual bonus scheme, subject to company and individual performance. In addition, we offer a comprehensive benefits package including c pension, private medical insurance, wellbeing programme, flexible benefits programme and more. What we offer No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way. We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive. Chiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination.