Senior Technical Leader, Protein Biologics Development, GRD CMC

Business Area: R&D, Pharmacovigilance & Regulatory Affairs
Job Type: Direct Employee
Contract Type: Permanent
Location: Parma, IT
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. Discover more here.
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 for
This is what you will do
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, 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 for
In 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