Senior Technical Leader, GRD CMC

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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

GRD Technical Leader is accountable for the budget, strategy and execution of CMC development and IMP supply of projects within the GRD portfolio from candidate nomination/selection to handover to manufacturing organisation for commercial launch.

The CMC director hold the role of technical leader on the CT and the ETT.

The CMC director can also hold the role of ETT workstream lead depending on the project deliverables.

• Build the overall strategic development plan incollaboration with product CT.
• Strategy of the CMC development including IMPsupply to meet the project milestones and longterm business objectives.
• Drive execution of the CMC development plan incompliance with the regulatory strategy.
• Coordinate building of documentation package fitfor development phase.
• Lead new business development opportunityevaluations with focus on CMC.
• Act as GRD CMC representative in project coreteam.
• Build and organize the ETT by sourcing the rightinternal and external competences according toproject needs.
• Lead and manage external consultants.
• Lead the ETT based on the project scope andstrategic development plan.
• Project budget accountability for CMC activities(CRO’s, CDMOs, main consultancy agreementsetc).
• Act as subject matter expert in areas ofcompetence
• Act as workstream lead depending on projectrequirements.
• Review the ETT workstreams development plansand align it with the overall strategic developmentplan.
• Providing technical support in scouting, auditing,and selection of CROs/CDMOs.
• Lead and manage long term relationships withacademic partners/CRO/CDMOs for successfuldelivery of collaboration and outsourced projectswith Chiesi values and shared value in mind.
• Provide technical review and approval, if neededand as seen fit, of relevant documentation toachieve proper quality for clinical trial applicationsand market approval applications
• Actively contribute and drive the development ofthe department in line with GRD and GRD R&Dstrategic goals.
• Disseminate technical knowledge and leadershipskills within department and to relevant adjacentfunctions throughout Chiesi.

• Minimum Master of Science in relevant field
• Minimum 10 years of relevant industrial experience from the pharmaceutical industry.
• Experience from development or manufacturing of drug substances, drug products or medical devices.
• Highly experienced in leading and managing internal and external activities, resources, and stakeholders.
• Experience from regulatory interactions with EMA and/or FDA and quality module 3 documentation and requirements.
• Experience fr