Senior Technical Leader, Analytical Method Development and Validation, 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 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 forIn this role, you will act as a senior technical leader and analytical CMC expert within GRD CMC. You will provide scientific and technical leadership for analytical method development, method qualification and validation, analytical control strategy, comparability, technology transfer, stability strategies, and lifecycle activities. You will lead an extended technical team and help ensure that analytical CMC deliverables are aligned with project objectives, regulatory expectations, quality requirements, timelines, and budget.

You will play an important role in building and retaining product knowledge within GRD, enabling effective decision-making, supporting external partner oversight, and helping establish fit-for-purpose ways of working for rare disease  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,…