Site & Team
The Tilburg site offers commercial manufacturing and development of gelatin-based drug delivery dosage forms (softgels) 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. The Formulation group is one of the pillars of the Research and Development (R&D) organization for Patheon Softgels BV. This group is committed to support all formulation activities related to lab development, risk assessment, data interpretation, prototype development, excipient selection and product and process design. The team is responsible for all formulation activities, delivering project activities on time and contribute to the improvement formulation activities and introduction of new products.
The role is in the formulation department of the R&D, which also includes Regulatory affairs, Project management, analytical development, validation, process technology and scale-up departments. The R&D organization functions as a matrix organization, with formulation representatives from the team reporting into the development project teams. Key for this position is to design and conduct formulation activities pertinent to a project in order to successfully develop new softgel products with robust and reliable formulations and manufacturing processes. Since the team also support various projects within the organization in all phases of development and commercial good interaction with various departments is key.
Design and perform customer driven development projects on the formulation of pharmaceutical and consumer healthcare products using Patheon technologies.
Conduct pre-formulation studies in lab and execute development projects on the formulation of (liquid) fill and shell formulations to improve bioavailability and stability.
Support and drive process development team during pilot scale manufacturing phases.
Understand Quality by Design principles to prepare formulation development risk assessment, protocols and reports.
Support customers through formulation development process and advise on appropriate strategy in relation to formulation development tailored to the clinical stage of development.
Assist formulation, process and project teams in organizing lab logistics (raw materials, samples, shipments), prepare manufacturing protocols for trial runs and ensure on time delivery of formulation deliverables within budgeted time.
Keep up to date with current regulatory requirements (ICH/FDA) guidelines, pharmacopoeia requirements and work under cGLP/cGMP environment.
Participate in improvement projects related to formulation and pharmaceutical development processes.
Support Regulatory team during product filing process in preparing the modules.
We welcome candidates that enjoy working in a multi-disciplinary, highly technical environment where personal development and team cooperation are key to success.
Academic education (MSc or PhD) level in pharmacy, food science, food technology, analytical chemistry, chemistry or biochemistry by education or experience.
Have a minimum of 5 years of working experience in product development area in pharma, healthcare, food or other relevant industry.
Good knowledge on cGMP and/or FDA/ICH guidelines.
Proven hands-on laboratory experience and mind set.
Experience on handling raw materials (e.g. gelatin, lipids, surfactants) and instruments (e.g. centrifuge, DLS, rheology) is preferred in combination with an attitude to continue to learn and conduct practical work on formulation development activities.
Have experience in the set up and maintenance of product master documentation.
Good report writing and presentation skills.
Good project management, and interpersonal skills, and ability to work in multidisciplinary environments
Ability to present results with clarity, work accurately and meticulously, with an eye for detail to avoid errors.
Have the ability to evaluate and distinguish colors and flavors.
Basic knowledge on analytical techniques like HPLC, GC is preferred
Strong written and spoken communications skills and proficiency in the English language. Dutch is a plus.
Diversity in our teams is an important element to create an effective and challenging working environment. Integrity, Intensity, Innovation and Involvement are key characteristics that we expect of all that are part of our community. A person who enjoys working with cross-function team on product development projects with an innovative mind along with hands-on and “can do” mentality will discover satisfaction in this role. The individual can flourish into a matrix organization, managing the complexity of the interface between functional and project organization and balance all priorities.
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.