Principal Scientist, Drug Product Process Engineer Full-time

Principal Scientist, Drug Product Process Engineer

Location: Siena, Italy

Employment type: Permanent, full time

Job Purpose

We are seeking an experienced Principal Scientist, Drug Product Process Engineering to support sterile drug product development through process engineering, process modelling, advanced analytics, and digital technologies.

In this role, you will provide technical leadership across development programs, applying scientific and engineering expertise to enhance process understanding, support scale-up and technology transfer, and deliver robust manufacturing processes. You will work within multidisciplinary teams and contribute to the adoption of innovative, data-driven approaches throughout development.

This is an individual contributor role with no direct reports.

Responsibilities:

Scientific & Technical Leadership

• Provide process engineering expertise within multidisciplinary CMC teams across development, scale-up, and commercialization activities.
• Apply modelling, data analytics, and digital tools to improve process understanding, performance, and robustness.
• Support sterile drug product process development, characterization, scale-up, and technology transfer across multiple modalities.
• Contribute scientific insight and risk-based recommendations to support technical decision-making and project progression.
• Identify and resolve technical challenges to enable successful development outcomes.

Collaboration & Project Delivery

• Collaborate effectively with development, manufacturing, and cross-functional teams to achieve project objectives.
• Contribute to planning and execution of development activities and milestones.
• Assess technical risks and recommend appropriate mitigation strategies.
• Support implementation of continuous improvement, modelling, and digitalization initiatives.
• Mentor junior scientists and share technical knowledge within the organization.

Regulatory & Scientific Communication

• Ensure compliance with applicable quality, regulatory, safety, and data integrity requirements.
• Author and review technical reports, development documentation, and regulatory submissions.
• Clearly communicate technical findings and recommendations to stakeholders.
• Contribute to innovation through publications, presentations, patents, or invention disclosures.

Basic Qualifications & Skills

• Engineering degree, Pharmaceutical Sciences, Biotechnology, or related discipline.
• Relevant experience in sterile drug product development, process engineering, and technology transfer within the pharmaceutical or biotechnology industry.
• Experience in process characterization, scale-up, manufacturing science, and process improvement.
• Experience applying modelling, PAT, automation, analytics, or digital technologies in development or manufacturing environments.
• Strong technical problem-solving, communication, and collaboration skills.
• Fluent written and verbal English is required; proficiency in another European language would be an advantage.

Preferred Qualifications & Skills

• Master's degree or PhD in a relevant scientific or engineering discipline.
• Experience with process modelling, data science, AI/ML, or digital development approaches.
• Experience leading technical workstreams or complex scientific projects.
• Demonstrated scientific contributions through publications, presentations, patents, or innovation activities.

What we offer:

• Permanent contract in a very inclusive environment
• Smart Working up to 50%
• Performance Reward
• Flexible Benefits
• Company Healthcare Plan
• Integrative pension fund
• Employee Assistance Programme
• Prevention services and vaccination clinic
• Tax assistance
• Local nursery agreement
• Postal service, laundry, shoe repair and tailoring
• On Site Gym
• On Site canteens and coffee corners
• Free company bikes and shuttle

Please note that international relocation support cannot be provided; therefore, only candidates who are already based in the indicated country can be considered.

Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.