R&D Manufacturing
16 ore fa
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 Research & DevelopmentOur 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).Who we are looking forThis is what you will doIn this role, you will lead and coordinate technical teams, laboratories, and equipment to support formulation and manufacturing process development activities, from laboratory to industrial scale, for MDIs and liquid dosage forms, including technology transfer.You will play a key role in advancing innovative technologies to support pipeline projects, while ensuring the highest standards of compliance with GMP/cGMP and HSE requirements across facilities, documentation, and personnel.You'll be responsible for:Lead and develop technical personnel, ensuring adequate project support in formulation and manufacturing process development, while promoting continuous technical, scientific, and soft-skills growth in compliance with GMP/cGMP, quality, and safety regulations (including D. Lgs *****).Oversee laboratories, rooms, and equipment, ensuring efficient use and full compliance with company, quality, safety, and regulatory requirements.Support planning, manufacturing, and evaluation of development batches, contributing to process development, scale-up, and technology transfer in collaboration with scientific teams.Promote the application of QbD, QRM, PAT, and Lean/6s approaches to enhance process understanding and robustness.Supervise the development and implementation of new technologies to support innovation and pipeline projects.Ensure compliance with regulatory and quality requirements by reviewing technical documentation, supporting change control, and contributing to quality investigations (deviations, OOS, complaints), while managing laboratories in accordance with Health Authority authorizations.Contribute to budget planning for laboratory equipment and investments.You will need to haveScientific degree (preferably Biotechnology, Chemical Engineering, chemistry, CTF or pharmacy).Significant experience (= 6 years) in technical development of pharmaceutical products.Experience in sterile liquids manufacturing.Technical SkillsStrong knowledge of key manufacturing methods and of the main techniques for technological characterization and process control of different pharmaceutical dosage forms, with particular focus on biological products.Solid knowledge of technology transfer processes and the industrialization of new products.Good capability to lead new technological implementation projects and the introduction of new systems.Proficiency in statistics and its application to drug manufacturing processes.Good understanding of QbD (Quality by Design) approach and PAT (Process Analytical Technology) methodologies.Knowledge of GMP/cGMP, safety, ISO standards, and key European and U.S. pharmaceutical regulations.Good command of English (both written and spoken).Power SkillsLeadership and influence;Sound decision-making and results orientation;Effective planning and execution;Collaboration and team building;Resilience and learning agility.LocationParmaWhat we offerNo 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.#J-*****-Ljbffr
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