ppbLocation: Italy (Hybrid working options available) /b /p pbSalary Range: €60,000 – €110,000 (dependent on experience) /b /p h3About the Opportunity /h3 pWe are supporting a growing, innovative biotechnology company developing next-generation therapies within a specialist therapeutic area. As the company continues to advance its pipeline through clinical development, they are seeking an experienced bCMC Manager /b to lead Chemistry, Manufacturing and Controls activities across their development programmes. /p pThis is an exciting opportunity for a CMC professional who enjoys working in a dynamic biotech environment, combining strategic oversight with hands‑on management of external development and manufacturing activities. The successful candidate will play a key role in ensuring the successful progression of assets from development through clinical supply and regulatory milestones. /p h3Position Summary /h3 pThe CMC Manager will be responsible for overseeing CMC activities related to pharmaceutical development, manufacturing, and regulatory support. This role will provide technical leadership across analytical development, formulation, process development, and external manufacturing activities, ensuring delivery of high-quality drug substances and drug products in line with regulatory expectations. /p pWorking closely with internal cross‑functional teams and external partners, the CMC Manager will support the development strategy of clinical‑stage programmes while ensuring compliance with global regulatory requirements, including FDA and EMA guidelines. /p h3Key Responsibilities /h3 ul liLead and coordinate CMC activities supporting pharmaceutical development and clinical programmes, including:



/li liDrug substance and drug product manufacturing /li liStability programmes and lifecycle activities /li liManage relationships with external CDMO/CMO partners, ensuring timely delivery of high‑quality materials for preclinical and clinical studies. /li liProvide technical oversight and strategic input into CMC development plans, working collaboratively with cross‑functional teams including: /li liRegulatory affairs /li liQuality /li liIntellectual property teams /li liSupport the selection, qualification, and management of external vendors and manufacturing partners. /li liEnsure CMC activities align with global regulatory expectations, including FDA, EMA, and applicable ICH guidelines. /li liSupport preparation and review of regulatory documentation, including CMC sections for clinical trial applications and marketing submissions. /li liProvide CMC expertise during interactions with regulatory authorities, including preparation for key development milestones and regulatory meetings. /li liMonitor industry trends, scientific advances, and regulatory developments relevant to pharmaceutical development and manufacturing. /li liProvide CMC input into intellectual property strategy and technical documentation. /li liManage project timelines, budgets, risks, and deliverables associated with outsourced CMC activities. /li /ul h3Candidate Profile /h3 pThe ideal candidate will have a strong background in pharmaceutical development and CMC strategy, with experience working within biotech, pharmaceutical, or a highly innovative drug development environment.



/p h3Required Experience /h3 ul liMaster’s degree or PhD in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related scientific discipline. /li liMinimum b8–10 years of experience /b in CMC development and manufacturing within the pharmaceutical or biotechnology industry. /li liProven experience managing outsourced CMC activities with external partners, including: /li liGMP manufacturing activities /li liStrong understanding of the drug development lifecycle, from early development through clinical supply and regulatory submission. /li liExperience supporting regulatory documentation, including IND, NDA, MAA, CTA, or equivalent submissions. /li liKnowledge of FDA, EMA, and ICH regulatory requirements related to CMC. /li liExperience supporting regulatory interactions, including late‑stage development discussions and CMC meetings with health authorities. /li liStrong project management skills with the ability to manage external suppliers, budgets, timelines, and technical deliverables. /li liExcellent communication and stakeholder management skills, with the ability to collaborate effectively across multidisciplinary teams. /li /ul h3Preferred Experience /h3 ul liExperience within CNS, neuroscience, or other specialised therapeutic areas. /li liExperience working within a virtual biotech or outsourced development model. /li liExperience managing CDMO relationships across international markets. /li /ul h3Why Join? /h3 pThis is an opportunity to join a growing biotech organisation where you will have significant ownership of CMC strategy and external manufacturing activities. The role offers exposure across the full development lifecycle and the chance to directly contribute to advancing innovative therapies towards clinical and regulatory milestones. /p /p #J-18808-Ljbffr

📌 CMC Manager (Milano)
🏢 Barrington James
📍 Milano