[Hiring] Senior Technical Leader, Protein Biologics Development @Chiesi Group

Role Description

Are 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.

In 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
• Critical quality attributes

You 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.

You will be responsible for:

• Acting as senior subject matter expert for protein biologics drug substance development, focusing on protein expression, process performance, manufacturability, and product quality.
• Leading or contributing to CMC strategies from candidate selection through clinical supply, technology transfer, process characterization, validation, regulatory submission, launch, and lifecycle management.
• Providing 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.
• Translating understanding of protein structure, function, expression, process parameters, and analytical data into risk-based CMC strategies and practical development decisions.
• Leading 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.
• Driving phase-appropriate control strategies covering process parameters, in-process controls, release testing, characterization, comparability, specifications, and lifecycle knowledge management.
• Leading technical risk assessments, process change assessments, comparability strategies, troubleshooting, investigations, deviations, CAPAs, and continuous improvement activities related to biologics drug substance development.
• Leading scientific and technical discussions with internal stakeholders, CDMOs, CROs, academic partners, and external consultants, ensuring alignment on development plans, deliverables, risks, budget, and timelines.
• Supporting 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.
• Contributing 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, biochemical engineering, cell biology, molecular biology, pharmacy, or a related discipline; an advanced degree is an advantage.
• Significant industrial experience in biologics CMC development, with deep expertise in recombinant protein drug substance development, protein expression, and manufacturing.
• Strong understanding of upstream and downstream processing, protein characterization, analytical control strategies, GMP, regulatory expectations, comparability, validation, and lifecycle management.
• Experience working with CDMOs, CROs, academic partners, external consultants, and outsourced development or manufacturing models.
• Proven 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.
• Excellent written and verbal communication skills in English.

Benefits

• Comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme, and more.
• Participation in an annual bonus scheme, subject to company and individual performance.
• Access to resources and training in a dynamic, friendly environment.
• Flexible working arrangements and remote work options.
• Tax assistance services for foreign colleagues.