Senior Technical Leader, Protein Biologics Development, GRD CMC

About us Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas.

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At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.

Diversity and inclusion are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better.

Chiesi Global Rare Diseases Chiesi Global Rare Diseases is a Chiesi Group’s business unit established in February 2020 and focused on research, development and commercialization of treatments and patient support services for rare and ultra-rare disorders, many of whom have limited or no treatments available.

This unit is based in Boston, Massachusetts, with a strong synergy with the headquarters in Parma. Rare unit has a focus on research and product development for lysosomal storage diseases, rare hematology, ophthalmology disorders and rare immunodeficiencies. The unit is also a dedicated partner with global leaders in scientific research, patient advocacy and care. Discover more here.

What we are looking forThis is what you will doAre 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  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, and 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 forIn this role, you will:

Act as senior subject matter expert for protein biologics drug substance development, with strong focus on protein expression, process performance, manufacturability, and product quality.

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…