Senior Technical Leader, GRD CMC

ppSelect how often (in days) to receive an alert: /p pBusiness Area: RD, Pharmacovigilance Regulatory Affairs /p pJob Type: Direct Employee /p pContract Type: Permanent /p pLocation: Parma, IT /p pbAbout us /b /p pChiesi 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. /p pAt 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. /p pDiversity 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. /p pbChiesi Global Rare Diseases /b /p pChiesi 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. /p pThis unit is based in Boston, Massachusetts, with a strong synergy with the headquarters in Parma. /p pRare 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 . /p pbWhat we are looking for /b /p h3bThis is what you will do /b /h3 pGRD 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. /p pThe CMC director hold the role of technical leader on the CT and the ETT. /p pThe CMC director can also hold the role of ETT workstream lead depending on the project deliverables. /p h3bYou will be responsible for /b /h3 ul liBuild the overall strategic development plan incollaboration with product CT. /li liStrategy of the CMC development including IMPsupply to meet the project milestones and longterm business objectives. /li liDrive execution of the CMC development plan incompliance with the regulatory strategy. /li liCoordinate building of documentation package fitfor development phase. /li liLead new business development opportunityevaluations with focus on CMC. /li liAct as GRD CMC representative in project coreteam. /li liBuild and organize the ETT by sourcing the rightinternal and external competences according toproject needs. /li liLead and manage external consultants. /li liLead the ETT based on the project scope andstrategic development plan. /li liProject budget accountability for CMC activities(CRO’s, CDMOs, main consultancy agreementsetc). /li liAct as subject matter expert in areas ofcompetence /li liAct as workstream lead depending on projectrequirements. /li liReview the ETT workstreams development plansand align it with the overall strategic developmentplan. /li liProviding technical support in scouting, auditing,and selection of CROs/CDMOs. /li liLead and manage long term relationships withacademic partners/CRO/CDMOs for successfuldelivery of collaboration and outsourced projectswith Chiesi values and shared value in mind. /li liProvide technical review and approval, if neededand as seen fit, of relevant documentation toachieve proper quality for clinical trial applicationsand market approval applications /li liActively contribute and drive the development ofthe department in line with GRD and GRD RDstrategic goals. /li liDisseminate technical knowledge and leadershipskills within department and to relevant adjacentfunctions throughout Chiesi. /li /ul h3bYou will need to have /b /h3 ul liMinimum Master of Science in relevant field /li liMinimum 10 years of relevant industrial experience from the pharmaceutical industry. /li liExperience from development or manufacturing of drug substances, drug products or medical devices. /li liHighly experienced in leading and managing internal and external activities, resources, and stakeholders. /li liExperience from regulatory interactions with EMA and/or FDA and quality module 3 documentation and requirements. /li liExperience from working with CMOs and CROs. /li liGood knowledge regarding GMP compliance. /li liGood knowledge of drug development framework including regulatory guidelines, best practices and industry standards /li liStrong leadership and problem-solving skills. /li liGood skills in written and verbal communication /li liEnglish - Fluent in verbal and written communication /li liNormal to experienced user of MS office /li liBroad general experience in the field of development and manufacturing of pharmaceuticals, including analytical development and testing (CGT, biologics and/or small molecules). /li /ul h3bLocation /b /h3 pEurope - Remote /p h3bCompensation range /b /h3 pThe 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. /p pThe 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. /p pThis role is eligible to participate in an annual bonus scheme, subject to company and individual performance. /p pIn addition, we offer a comprehensive benefits package including c pension, private medical insurance, wellbeing programme, flexible benefits programme and more. /p pbWhat we offer /b /p pNo 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. /p pWe 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. /p pChiesi 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. /p /p #J-18808-Ljbffr