Ph3Head of Biologic Drug Substance - Process Analytical Development /h3 pDate: 30 Apr 2026 /p pDepartment: GTD Global Technical Development /p pBusiness Area: RD, Pharmacovigilance Regulatory Affairs /p pJob Type: Direct Employee /p pContract Type: Permanent /p pLocation: Parma, IT /p h3About us /h3 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 h3Chiesi Research Development /h3 pOur RD 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, RD 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). /p h3Who we are looking for /h3 h3This is what you will do /h3 pWe are seeking an accomplished and visionary leader to join the Global Technical RD 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. /p pThis is a critical leadership position that will directly influence the future pipeline and technical success of our biological product portfolio. /p h3You will be responsible for /h3 h3Strategic Functional Leadership /h3 ul liLead 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. /li liDirect the design, development, and optimization of robust, scalable, and compliant biopharmaceutical manufacturing processes. /li liEnsure ongoing compliance with global CMC regulations and implement evolving regulatory expectations, industry standards, and best practices. /li /ul h3Cross-Functional Program Leadership /h3 ul liPartner 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. /li liLead 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. /li liChampion innovation and continuous improvement across biologics development, introducing new technologies, methodologies, and scientific approaches that enhance performance and efficiency. /li /ul h3Technical Analytical Excellence /h3 ul liTechnical 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. /li liAssess and interpret complex data to guide scientific decisions, mitigate risks, and inform resource allocation and program strategy. /li liCommunicate program status, development findings, and recommendations to senior leadership, internal partners, and regulatory agencies. /li liProvide hands‑on leadership in technology transfer, scale‑up, and process validation to ensure efficient transition from lab to clinical and commercial production. /li liApply and promote Quality by Design (QbD) principles; contribute to the development of control strategies and validation plans. /li liLead CMC contributions for regulatory submissions (MAA/NDA/BLA/JNDA) and support interactions with health authorities. /li /ul h3You will need to have /h3 ul liAt least 10 years of experience in biopharmaceutical drug substance process development, with a record of leadership in complex biologics CMC programs. /li liDeep understanding of FDA, EMA, ICH, and global CMC guidelines, with demonstrated success translating regulatory expectations into practice. /li liSignificant experience managing CDMO partnerships and external development packages. /li liStrong background in scientific due diligence for technologies and potential pipeline assets. /li liAdvanced analytical and problem‑solving skills, with the ability to synthesize complex datasets into actionable insights. /li liProven leadership capability, with strong communication skills and the ability to influence across all organizational levels. /li liAdvanced scientific degree (Ph.D. or M.Sc.) preferred; relevant experience with a Bachelor’s degree will be considered. /li liDirect experience in technology transfer, scale‑up, and commercial readiness. /li liDemonstrated application of QbD principles and track record in lifecycle management. /li liStrong capability in executive presentations, including communicating development strategies and investment cases. /li liWillingness to travel domestically and internationally as needed. /li liExperience in building and developing high‑performing teams; enthusiasm for shaping a new department. /li /ul h3Location /h3 pPreferred locations are Italy and Sweden, with possibility or smart working. /p h3What we offer /h3 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