Senior Technical Leader, Analytical Method Development and Validation

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

• Provide scientific and technical leadership for analytical method development, method qualification and validation, analytical control strategy, comparability, technology transfer, stability strategies, and lifecycle activities • Lead an extended technical team and align analytical CMC deliverables with project objectives, regulatory expectations, quality requirements, timelines, and budget • Build and retain product knowledge within GRD to support decision-making and external partner oversight • Act as subject matter expert for analytical method development, qualification and validation, analytical control strategy, comparability, stability, and related CMC areas for biological products such as protein therapeutics • Lead or contribute to CMC strategies from candidate selection through clinical supply, technology transfer, process characterization, validation, regulatory submission, launch, and lifecycle management • Provide 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 • Translate protein structure, function, expression, process parameters, and analytical data into risk-based CMC strategies and development decisions • Lead identification and management of critical and key product quality attributes • Drive phase-appropriate control strategies covering process parameters, in-process controls, release testing, characterization, comparability, specifications, and lifecycle knowledge management • Lead technical risk assessments, process change assessments, comparability strategies, troubleshooting, investigations, deviations, CAPAs, and continuous improvement activities • Lead technical discussions with internal stakeholders, CDMOs, CROs, academic partners, and external consultants • Support selection, evaluation, and oversight of external development and manufacturing partners • Contribute to technical and regulatory documentation, business development and due diligence assessments, and GRD CMC ways of working

🎯 Requirements

• A university degree in biotechnology, biochemistry, chemistry, biology, pharmacy, engineering, or a related scientific discipline; an advanced degree is an advantage • Significant experience in analytical method development, method qualification and validation for biologics • Experience with analytical control strategy, stability testing, comparability, technology transfer, or lifecycle management within CMC development • Strong scientific understanding of analytical techniques relevant to biologics development, including assay performance, robustness, method lifecycle, data interpretation, and regulatory expectations for validated methods • Strong understanding of GMP, regulatory expectations, quality systems, and development requirements for clinical and/or commercial manufacturing • Experience working with CDMOs, CROs, external partners, or outsourced development and manufacturing models • Ability to translate complex technical information into clear recommendations, fit-for-purpose plans, and practical decisions • Experience leading technical discussions, coordinating cross-functional activities, and influencing stakeholders in a matrix environment • Excellent written and verbal communication skills in English • Proactive, solution-oriented, and comfortable taking responsibility in situations where priorities may evolve

🏖️ 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 • Relocation support • Flexible working arrangements • Remote work options • Tax assistance services for foreign colleagues • Access to resources and training • Performance bonuses