Senior Technical Leader, Protein Biologics Development, GRD CMC

ppBusiness 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 pAre you an experienced biologics CMC leader with deep expertise in protein drug substance development, protein expression, and product quality attributes? In GRD CMC, we are strengthening our technical leadership for protein biologics to ensure robust, science-driven development strategies that connect process design, product quality, and patient needs. /p pIn this role, you will act as the senior GRD CMC technical leader for protein biologics drug substance development. The main responsibilities are aligned with the broader GRD CMC Technical Leader role, with a dedicated focus on recombinant protein therapeutics, including protein expression systems, upstream and downstream process development, process scalability, analytical control strategy, comparability, and critical quality attributes. /p pYou will lead extended technical teams and ensure that CMC strategies, development plans, budgets, timelines, risk assessments, and key decisions are scientifically sound and aligned with project objectives, regulatory expectations, quality requirements, and lifecycle needs. You will also play a central role in building and retaining deep product and process knowledge within GRD. /p h3bYou will be responsible for /b /h3 pIn this role, you will: /p ul liAct as senior subject matter expert for protein biologics drug substance development, with strong focus on protein expression, process performance, manufacturability, and product quality. /li liLead or contribute to CMC strategies from candidate selection through clinical supply, technology transfer, process characterization, validation, regulatory submission, launch, and lifecycle management. /li liProvide expert guidance on expression systems, cell line development, clone selection, cell banks, media and feed development, upstream process development, harvest, clarification, purification, impurity clearance, scale‑up, and process control. /li liTranslate understanding of protein structure, function, expression, process parameters, and analytical data into risk‑based CMC strategies and practical development decisions. /li liLead identification and management of critical quality attributes and key product quality attributes, including potency, purity, identity, glycosylation, charge variants, aggregation, fragments, process‑related impurities, host cell proteins, host cell DNA, and stability. /li liDrive phase‑appropriate control strategies covering process parameters, in‑process controls, release testing, characterization, comparability, specifications, and lifecycle knowledge management. /li liLead technical risk assessments, process change assessments, comparability strategies, troubleshooting, investigations, deviations, CAPAs, and continuous improvement activities related to biologics drug substance development. /li liLead scientific and technical discussions with internal stakeholders, CDMOs, CROs, academic partners, and external consultants, ensuring alignment on development plans, deliverables, risks, budget, and timelines. /li liSupport selection, evaluation, and oversight of external development and manufacturing partners by assessing technical capability, platform fit, manufacturing readiness, analytical capability, facility fit, and development risks. /li liContribute to technical and regulatory documentation, business development and due diligence assessments, and the development of GRD CMC ways of working for protein biologics. /li /ul h3bYou will need to have /b /h3 pWe are looking for a senior CMC professional with strong scientific depth in protein biologics development and the ability to connect detailed technical understanding with broader project strategy. /p pYou will need to have: /p ul liA university degree in biotechnology, biochemistry, biochemical engineering, cell biology, molecular biology, pharmacy, or a related discipline; an advanced degree is an advantage. /li liSignificant industrial experience in biologics CMC development, with deep expertise in recombinant protein drug substance development, protein expression, and manufacturing. /li liStrong understanding of upstream and downstream processing, protein characterization, analytical control strategies, GMP, regulatory expectations, comparability, validation, and lifecycle management. /li liExperience working with CDMOs, CROs, academic partners, external consultants, and outsourced development or manufacturing models. /li liProven ability to lead extended technical teams, coordinate cross‑functional activities, influence stakeholders, and translate complex technical data into clear recommendations, risk assessments, and decision points. /li liExcellent written and verbal communication skills in English. /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