Head of Biologic Drug Substance - Process & Analytical Development

Date: 29 May 2026 Department: GTD Global Technical Development Business Area: R&D, Pharmacovigilance & Regulatory Affairs Job Type: Direct Employee Contract Type: Permanent Location: 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 & 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). Who we are looking for This is what you will do We are seeking an accomplished and visionary leader to join the Global Technical R&D organization as the head of Biologic Drug Substance Process and Analytical Development. This role is responsible for defining and executing the strategy for biologics CMC development—including process development, analytical sciences, and regulatory readiness—from early-stage research through commercial launch. This is a critical leadership position that will directly influence the future pipeline and technical success of our biological product portfolio. You will be responsible for Strategic & Functional Leadership Lead and oversee all Drug Substance Process & Analytical Development activities, setting strategy and ensuring organizational goals are met. Deliver integrated development plans for high-value biologic programs—early and late stage—on time, to budget, and with the required quality. Direct the design, development, and optimization of robust, scalable, and compliant biopharmaceutical manufacturing processes. Ensure ongoing compliance with global CMC regulations and implement evolving regulatory expectations, industry standards, and best practices. Cross-Functional & Program Leadership Partner with Clinical, Quality Assurance, Regulatory Affairs, Strategic Outsourcing, Operations, and Preclinical teams to ensure seamless, high-quality program execution and effective technology transfer to commercial manufacturing. Lead strategic interactions with CDMOs. Manage external work packages, evaluate potential manufacturing partners, and drive end-to-end development strategies that integrate clinical, commercial, and regulatory priorities. Champion innovation and continuous improvement across biologics development, introducing new technologies, methodologies, and scientific approaches that enhance performance and efficiency. Technical & Analytical Excellence Technical competence on Upstream and Downstream processes; experiences on Pilot facility in Cell culture (i.e. Mammalian, Bacterial, Vaccines, Peptides Biosimilars), Downstream, Engineering, Analytical & Characterization, Process Services; preferable experience on support late-stage process development, Scale-up / down, Technology Transfers and Regulatory procedures. Assess and interpret complex data to guide scientific decisions, mitigate risks, and inform resource allocation and program strategy. Communicate program status, development findings, and recommendations to senior leadership, internal partners, and regulatory agencies. Provide hands-on leadership in technology transfer, scale-up, and process validation to ensure efficient transition from lab to clinical and commercial production. Apply and promote Quality by Design (QbD) principles; contribute to the development of control strategies and validation plans. Lead CMC contributions for regulatory submissions (MAA/NDA/BLA/JNDA) and support interactions with health authorities. You will need to have At least 10 years of experience in biopharmaceutical drug substance process development, with a record of leadership in complex biologics CMC programs. Deep understanding of FDA, EMA, ICH, and global CMC guidelines, with demonstrated success translating regulatory expectations into practice. Significant experience managing CDMO partnerships and external development packages. Strong background in scientific due diligence for technologies and potential pipeline assets. Advanced analytical and problem-solving skills, with the ability to synthesize complex datasets into actionable insights. Proven leadership capability, with strong communication skills and the ability to influence across all organizational levels. Advanced scientific degree (Ph.D. or M.Sc.) preferred; relevant experience with a Bachelor’s degree will be considered. Direct experience in technology transfer, scale-up, and commercial readiness. Demonstrated application of QbD principles and track record in lifecycle management. Strong capability in executive presentations, including communicating development strategies and investment cases. Willingness to travel domestically and internationally as needed. Experience in building and developing high-performing teams; enthusiasm for shaping a new department. Location Preferred locations are Italy and Sweden, with possibility or smart working. 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. DISCOVER ALL OUR JOB OPPORTUNITIES Please enable JavaScript Screen readers cannot read the following searchable map. Follow this link to reach our Job Search page to search for available jobs in a more accessible format.