Senior Technical Leader, GRD CMC

Job not on LinkedIn

🕒 August 12

🇮🇹 Italy – Remote

💵 €68.5k / year

⏰ Full Time

🟠 Senior

🧑‍💻 Full-stack Engineer

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Chiesi Group

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

🏥 Healthcare

🏭 Manufacturing

💊 Pharmaceuticals

Healthcare • Manufacturing • Pharmaceuticals

Chiesi Group is a global pharmaceutical company that focuses on the research, development, and commercialization of innovative medicines. Known for its commitment to improving the lives of patients, the company specializes in areas such as respiratory diseases, special care, and rare diseases. Chiesi Group emphasizes sustainability and corporate responsibility, aiming to enhance health and well-being across the globe while also being dedicated to environmental stewardship.

📋 Description

• Own the budget, strategy and execution of CMC development and IMP supply projects within the GRD portfolio from candidate nomination/selection through handover to manufacturing for commercial launch • Build the overall strategic development plan in collaboration with the product core team • Develop the CMC strategy, including IMP supply, to meet project milestones and long-term business objectives • Drive execution of the CMC development plan in compliance with the regulatory strategy • Coordinate development-phase documentation packages • Lead new business development opportunity evaluations with focus on CMC • Represent GRD CMC in the project core team • Build and organize the external technical team by sourcing internal and external competences • Lead and manage external consultants and the external technical team • Hold project budget accountability for CMC activities, including CROs, CDMOs and consultancy agreements • Act as a subject matter expert and workstream lead as required • Review workstream development plans and align them with the overall strategic development plan • Provide technical support in scouting, auditing and selecting CROs/CDMOs • Lead long-term relationships with academic partners, CROs and CDMOs • Provide technical review and approval of documentation for clinical trial and market approval applications • Contribute to department development in line with GRD and GRD R&D strategic goals • Disseminate technical knowledge and leadership skills across the department and relevant adjacent functions

🎯 Requirements

• Minimum Master of Science in relevant field • Minimum 10 years of relevant industrial experience from the pharmaceutical industry • Experience from development or manufacturing of drug substances, drug products or medical devices • Highly experienced in leading and managing internal and external activities, resources, and stakeholders • Experience from regulatory interactions with EMA and/or FDA and quality module 3 documentation and requirements • Experience from working with CMOs and CROs • Good knowledge regarding GMP compliance • Good knowledge of drug development framework including regulatory guidelines, best practices and industry standards • Strong leadership and problem-solving skills • Good skills in written and verbal communication • Project leader skills • English - Fluent in verbal and written communication • Normal to experienced user of MS Office • Broad general experience in development and manufacturing of pharmaceuticals, including analytical development and testing (CGT, biologics and/or small molecules)

🏖️ Benefits

• Annual bonus scheme, subject to company and individual performance • Pension • Private medical insurance • Wellbeing programme • Flexible benefits programme • Comprehensive healthcare programs • Work-life balance initiatives • Robust relocation support • Performance bonuses • Flexible working arrangements • Remote work options • Tax assistance services for foreign colleagues • Access to resources and training • Professional development opportunities