Description
We are seeking an experienced Principal Scientist, Drug Product Process Engineer 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.
Responsibilities:
- 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.
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