[Hiring] Senior Technical Leader, Analytical Method Development and Validation @Chiesi Group

Role Description

Are you an experienced CMC professional who wants to help shape the future of rare disease development? In GRD CMC, we are building a dedicated technical leadership team with end-to-end responsibility for CMC strategy, execution, budget, and technical risk management across development projects, business development opportunities, and lifecycle activities.

As part of the GRD CMC team, you will work close to science, projects, and decision-making. You will contribute to the development by translating scientific understanding into robust CMC strategies, practical development plans, and reliable technical execution. You will collaborate with internal functions, external CDMOs, CROs, and partners to ensure that products can progress efficiently from candidate selection through clinical development, technology transfer, regulatory submission, launch, and lifecycle management.

You will be responsible for:

• Acting as a senior technical leader and analytical CMC expert within GRD CMC.
• Providing scientific and technical leadership for analytical method development, method qualification and validation, analytical control strategy, comparability, technology transfer, stability strategies, and lifecycle activities.
• Leading an extended technical team and ensuring that analytical CMC deliverables are aligned with project objectives, regulatory expectations, quality requirements, timelines, and budget.
• Building and retaining product knowledge within GRD, enabling effective decision-making, supporting external partner oversight, and establishing fit-for-purpose ways of working for rare disease development.

In this role, you will:

• Act as subject matter expert within analytical method development, method qualification and validation, analytical control strategy, comparability, stability, and related CMC technical 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 understanding of protein structure, function, expression, process parameters, and analytical data into risk-based CMC strategies and practical development decisions.
• Lead 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.
• 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 related to biologics drug substance development.
• Lead scientific and technical discussions with internal stakeholders, CDMOs, CROs, academic partners, and external consultants, ensuring alignment on development plans, deliverables, risks, budget, and timelines.
• Support 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.
• Contribute to technical and regulatory documentation, business development and due diligence assessments, and the development of GRD CMC ways of working for protein biologics.

Qualifications

• A university degree in biotechnology, biochemistry, chemistry, biology, pharmacy, engineering, or a related scientific discipline; an advanced degree is an advantage.
• Significant experience from analytical method development, method qualification and validation for biologics, including 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.

Requirements

• Proactive, solution-oriented, and comfortable taking responsibility in situations where priorities may evolve and not all answers are known from the start.
• Ability to communicate clearly, build trust, and enjoy working with others to solve complex scientific and technical challenges.
• Motivated by the opportunity to build something new, contribute to rare disease development, and ensure that critical CMC knowledge remains close to the projects and patients we serve.

Benefits

• Comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme, and more.
• Competitive salary package, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market.
• Flexible working arrangements, remote work options, and tax assistance services for foreign colleagues.