Job Description
Site Overview
$ads={1}
The Tilburg site offers commercial manufacturing and development of gelatin based drug delivery dosage forms (soft gels) for over-the-counter and prescription medicines. The site has been a Thermo Fisher Center of Excellence since 1994, offering extensive capabilities for a variety of soft gel technologies.
Team Overview
The Formulation team is one of the pillars of the R&D organization for Patheon Softgels BV by Thermo Fisher Scientific. We are committed to lead and support activities related to innovation, risk assessment, excipient selection, lab scale formulation development, data interpretation, prototype manufacturing, and product and process design up to validation stage. The team is responsible for all formulation activities, contributing to innovation of different softgel technologies, delivering project activities on time and contribute to the improvement formulation activities and introduction of new products. Diversity in our team is an important element to build an effective and engaging working environment.
R&D also includes Regulatory affairs, Project management, analytical development, validation, process technology and scale-up departments. R&D also functions as a matrix organization, with formulation representatives from the team reports into the development project teams led by project management.
Position Overview
As a Formulation Scientist (mid-level) at our Tilburg site we will welcome you into the Formulation Department within R&D division where you will actively work towards the advancement of formulation concepts and proprietary technologies for Softgel products. You will be responsible to drive and conduct both pre-formulation and formulation activities, develop recipes for both Softgel shell and fillings, design experiments employing QbD principles, screen raw materials considering pharmacopoeia standards incorporating risk-based approach, work effectively with external partners (Clients, collaborators and suppliers) and internal partners. Support management of processes, and equipment design for clinical, scale-up, and registration batches.
Responsibilities & Tasks will include:
Design and perform internal and external (client-based) development projects on the formulation (fill and shell) of pharmaceutical and consumer healthcare products using Patheon technologies. Conduct (pre-) formulation studies in the lab while following cGLP/cGMP guidelines. Ensure on time delivery of formulation tasks within budgeted time.
Demonstrate scientific and technical knowledge to drive projects and exercise technical know-how to understand the relationship between formulation characterization and biopharmaceutical performance.
Support and drive the process development team during pilot scale manufacturing phase e.g. Prepare manufacturing protocols for trial runs, initiate cleaning assessment and setting up of specifications for manufacturing readiness etc.
Support Regulatory Team in preparing the CMC modules during product filing process. Keeping up to date with regulatory & pharmacopoeia requirements (ICH/FDA).
Understanding Quality by Design principles to prepare formulation development risk assessments, protocols and reports.
Supporting customers through the formulation development process and giving mentorship on formulation development plans
Provide technical training and share scientific knowledge with juniors and peers in the areas of drug development, equipment, and processes to the department.
Qualification/Proficiencies
- MSc or PhD in pharmacy, chemistry (organic, medicinal, polymer), biochemistry, food science or food technology
- Have a minimum of 5 years of working experience in product development area in pharma, healthcare or other relevant industry with and hands-on laboratory experience
- Knowledge on cGMP, and/or FDA/ICH guidelines, basic understanding of QbD principles
- Chemical understanding and handling experience of excipients (e.g. gelatin, lipids, polymers, surfactants) and instrumentation (e.g. centrifuge, DLS, rheology, texture analyzer, dissolution)
- Good report writing and presentation skills; Excellent interpersonal & communication skills
- Good knowledge of written and spoken English language, Dutch Language is a Plus.
- The ability to evaluate and distinguish colours and flavours
- Basic knowledge of analytical techniques like HPLC, GC is beneficial
