CMC Technical Leader
Europe - remote, IT
About us
Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with 90 years’ experience, operating in 31 countries with more than 7,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas: Discover more here
We are proud to have been awarded with B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes a transparent and ethical behavior at all levels.
We believe that the success of Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors. Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors.
We are committed to embrace diversity, inclusion and equal opportunities. In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.
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
Purpose
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 successful candidate is highly experienced in the field of drug development. The candidate appreciates leading an international team of experts were she/he can provide strategic guidance as well as make use of her/his subject matter expertise. Further should the candidate appreciate teamwork and be communication, leadership and social savvy to make the development run as smooth as possible.
Main Responsibilities
• Build the overall strategic development plan in collaboration with product/project Core Team.
• Meet the project milestones and long term business objectives.
• Drive execution of the CMC development plan in compliance with the regulatory strategy.
• Lead new business development opportunity evaluations with focus on CMC.
• Build and organize an extended technical team 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
• Review the ETT workstreams development plans and align it with the overall strategic development plan.
• 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.
Experience Required
• Minimum 10 years of relevant industrial experience from the pharmaceutical industry.
• Experience from analytical or process development or manufacturing of drug substances, drug products or medical devices. Experience in the cell and gene therapy/advanced therapeutic and medicinal product field is meriting. Especially round RNA and LNP development and analysis.
• Highly experienced in working in an international environment 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.
Education
Minimum Master of Science in relevant field
Languages
English - Fluent in verbal and written communication
Technical Skills
• Good knowledge regarding GMP compliance and process and method validations.
• Good knowledge of drug development framework including regulatory guidelines, best practices and industry standards
• Project leader skills
Soft Skills
- Communication skills
- Leadership and social influence
- Planning and organizational skills
- Strategic thinking
- Team working
- Problem solving
What we offer
You would join a dynamic, fast-growing, challenging and friendly environment.
In Chiesi we firmly believe that our people are our most valuable asset, that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and collective well-being.
We want our people to come to work happy every day, and we know how important it is to find the right work-life balance in order to be able to give our best. That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.
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