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. The Group researches, develops and markets innovative drugs across its main therapeutic areas.

In 2024, the Biotech Center of Excellence was inaugurated in Parma, a new center of excellence for the research, development and manufacturing of biologic medicines. The Biotech Center of Excellence focuses on biotechnological innovation, with particular emphasis on the development of monoclonal antibodies, enzymes and other complex proteins.

For the Global Product Industrialization Department, reporting directly to the VP of Global Product Industrialization, we are looking for an experienced professional to fill the position of:

Head of DS Biotech, Process Industrialization

Main responsibilities

The role of Head of DS Biotech Process Industrialization is designed to lead the Drug Substance (DS) Biotech Process capability within Global Product Industrialization. This role is accountable for driving the end-to-end industrialization, lifecycle management and continuous improvement of upstream and downstream biopharmaceutical processes, ensuring successful transition from development to commercial manufacturing. The position operates at the intersection of R&D, Manufacturing, Quality and external partners (CDMOs), providing strategic and technical leadership to enable robust, scalable and compliant biologics production. The role plays a critical part in strengthening product know-how, supporting regulatory strategies, and building a best-in-class industrialization platform aligned with global standards.

• Leadership & Strategy
  • Lead the DS Biotech Process function, defining strategy, priorities and resource allocation across programs;
  • Drive process insourcing initiatives, ensuring effective plant adaptation and knowledge transfer;
  • Build and promote a strong product know-how culture across the organization.
• Process Development & Industrialization
  • Oversee upstream and downstream process development, optimization and characterization activities;
  • Ensure successful technology transfer, scale-up and process validation (clinical to commercial);
  • Guide pilot-scale studies and data-driven process optimization initiatives.
• Lifecycle Management
  • Ensure end-to-end lifecycle management of biotech processes, including continuous improvement;
  • Support deviation management, change control and CAPA systems with strong scientific rationale.
• Cross-functional Integration
  • Act as key interface between R&D, Production, Quality, Engineering and Regulatory Affairs;
  • Manage relationships with CDMOs and external development partners.
• Quality & Compliance
  • Embed Quality by Design (QbD) principles and develop robust control strategies;
  • Contribute to regulatory submissions (BLA, MAA, NDA) and support interactions with health authorities;
  • Ensure full compliance with GMP and global regulatory requirements.
• Operational & Technical Support
  • Support production scale-up, validation batches and industrial performance;
  • Supervise lab, pilot, industrial trials;
  • Oversee preparation of process documentation (risk assessments, validation protocols, batch records);
  • Enable capability building through training and coaching of manufacturing teams.

Candidate profile

• MSc or PhD in Biotechnology, Biochemical Engineering, Biochemistry or related scientific discipline
• Minimum 10–15+ years in biopharmaceutical drug substance development and industrialization
• Proven leadership in complex biologics CMC programs across development and commercial stages
• Deep expertise in biopharmaceutical upstream and downstream processes, including mammalian cell culture (e.g., CHO systems)
• Strong knowledge of process characterization, QbD and control strategy development
• Solid background in: 
  • Single-use bioreactor systems
  • Cell culture process optimization
  • Process troubleshooting and deviation analysis
• Ability to interpret complex datasets and translate them into actionable process and business decisions
• Demonstrated experience in: 
  • Process development and scale-up/down
  • Technology transfer to GMP manufacturing
  • Process validation and lifecycle management
• Advanced understanding of GMP environments and regulatory frameworks (FDA, EMA, ICH)
• Experience managing CDMO relationships and external development packages
• Expertise in cell banking, process fermentation, pilot scale centrifugation, laboratory, pilot and industrial scale membrane filtration, enzymatic reactions, Pegylation, chromatography purification, vacuum and freeze drying, protein characterization
• Exposure to regulated manufacturing environments (FDA/EMA-approved sites)
• Strong track record in process optimization, troubleshooting and regulatory interactions
• Strong leadership and team development capabilities
• Excellent cross-functional collaboration and stakeholder influencing skills
• Strategic mindset with the ability to connect science, operations and business priorities
• Advanced analytical and problem-solving capabilities
• Ability to operate effectively in a global, fast-paced and matrix environment
• Excellent communication skills in English

Location

Headquarters Parma, Italy.

The position is Smart Working eligible.

In the first months a higher presence in person needs to be considered.

Compensation range

The minimum salary for this role is € 74.320. The final offer will reflect the candidate’s skills, experience, qualifications and internal equity considerations.

In addition, the Company offers a comprehensive benefits package, including a company car and robust relocation support.

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