[Hiring] Senior Technical Leader @Chiesi Group

Role Description

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 holds 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.

You will be responsible for:

• Build the overall strategic development plan in collaboration with product CT.
• Strategy of the CMC development including IMP supply to meet the project milestones and long-term business objectives.
• Drive execution of the CMC development plan in compliance with the regulatory strategy.
• Coordinate building of documentation package fit for development phase.
• Lead new business development opportunity evaluations with focus on CMC.
• Act as GRD CMC representative in project core team.
• Build and organize the ETT by sourcing the right internal and external competences according to project needs.
• Lead and manage external consultants.
• Lead the ETT based on the project scope and strategic development plan.
• Project budget accountability for CMC activities (CRO’s, CDMOs, main consultancy agreements etc).
• Act as subject matter expert in areas of competence.
• Act as workstream lead depending on project requirements.
• Review the ETT workstreams development plans and align it with the overall strategic development plan.
• Providing technical support in scouting, auditing, and selection of CROs/CDMOs.
• Lead and manage long-term relationships with academic partners/CRO/CDMOs for successful delivery of collaboration and outsourced projects with Chiesi values and shared value in mind.
• Provide technical review and approval, if needed and as seen fit, of relevant documentation to achieve proper quality for clinical trial applications and market approval applications.
• Actively contribute and drive the development of the department in line with GRD and GRD R&D strategic goals.
• Disseminate technical knowledge and leadership skills within department and to relevant adjacent functions throughout Chiesi.

Qualifications

• 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 from working with CMOs and CROs.
• Good knowledge regarding GMP compliance.
• Good knowledge of drug development framework including regulatory guidelines, best practices and industry standards.
• Strong leadership and problem-solving skills.
• Good skills in written and verbal communication.
• Project leader skills.
• English - Fluent in verbal and written communication.
• Normal to experienced user of MS Office.
• Broad general experience in the field of development and manufacturing of pharmaceuticals, including analytical development and testing (CGT, biologics and/or small molecules).

Compensation

The minimum salary for this role is €68.480, aligned to our established salary framework. The final offer will reflect the candidate’s skills, experience, qualifications and internal equity considerations.

• This role is eligible to participate in an annual bonus scheme, subject to company and individual performance.
• In addition, we offer a comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme and more.

What we offer

No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way.

• Top-class benefits, including comprehensive healthcare programs.
• Work-life balance initiatives.
• Robust relocation support.
• Competitive salary package, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market.
• Flexible working arrangements and remote work options.
• Tax assistance services for foreign colleagues.

Equal Opportunity Employer

Chiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws.