Are you a driven specialist with strong analytical skills and experience in solid oral dosage forms? Do you have a background in developing manufacturing processes and want to contribute to the successful completion of Technology Transfers? Then this position is perfect for you!
Who are we?
Every human and animal deserves fair and safe medicine. Our shared goal is to make a difference in the health of both humans and animals. At the Ofichem Group, we work day and night to achieve this.
The Ofichem Group produces, develops, and distributes active pharmaceutical ingredients (APIs) for both humans and animals. These active substances are distributed worldwide to pharmaceutical manufacturers. The Ofichem Group upholds high standards in GMP, Safety Health Environment (SHE), and ISO 9001, delivering innovative solutions that protect and enhance the performance of medicines in global markets.
Ofimedicine operates from the Bio Science Park in Leiden and specializes in high-quality generic medicines, providing services for the European market. With our R&D laboratory, GCLP laboratory, and GMP production environment, we offer flexible solutions on both large and small scales.
Job Description
As a Formulation Specialist, you will be responsible for interpretation of the CMC part of our customers products and developing the manufacturing processes for all unit operations required for manufacturing our final products. In addition, you play an important role in the successful completion of Technology Transfers. You are a key player in process improvements and the development of innovative products.
Key responsibilities
- Interpreting the CMC section of customer dossiers and translating it into suitable manufacturing processes within our GMP manufacturing environment.
- Coordinating and/or conducting formulation and small-scale process characterization studies within the development lab.
- Coordinating and/or conducting technical feasibility studies for the introduction of new excipients in the plant.
- Advice on process-scale and batch size for new products based on the capacity of the manufacturing equipment.
- Writing batch manufacturing records for new products.
- Collaborating with other departments such as Operations, QA, and Validation to ensure a successful transfer to production.
- Supporting the operational execution of technical batches.
Prepare accurate and timely reports.
- Contributing to the optimization of existing commercial-scale productions processes.
- Managing development equipment.
What we ask of you
Minimum of a bachelor's degree (HBO level) in pharmacy, chemistry, or (process) technology.
Knowledge of manufacturing processes for solid oral dosage forms, such as wet granulation, fluidized bed drying, direct compression, tableting, and (sugar) coating is a pre.
Experience working in compliance with GMP standards.
Several years of experience in a similar role is an advantage.
Strong verbal and written communication skills in both Dutch and English.
Proactive and solution-oriented mindset.
What We offer
One-year contract with the prospect of a permanent position.
Opportunities for development and personal growth.
A competitive salary.
28 vacation days (fulltime) and 8% holiday allowance.
32 to 40-hour workweek.
Do you have any questions or need more information? Contact our HR department at hrm@ofichem.com or apply directly by sending your CV and motivation letter via email to recruitment@ofichem.com.
Acquisition in response to this vacancy is not appreciated.
