Synthon is an international pharmaceutical company, and a leader in the field of generic human medicines. Founded in 1991, Synthon has been working in biotechnology since 2007 and is developing rapidly into a specialty pharmaceutical company. We work to develop therapies that address the needs of people worldwide and help improve their health and well-being. With our portfolio of innovative medicines, we will provide treatment options for patients in selected therapeutic areas with high unmet medical needs. Through the provision of high-quality generic medicines, we make treatments more affordable and increase access to important remedies. Currently, our products are approved by regulatory agencies in more than 90 countries and marketed through strategic partnerships and – in dedicated areas – through direct sales.
Synthon’s head office is based in Nijmegen, the Netherlands, and the company has affiliates in eight other countries. In 2018, it recorded a turnover of EUR 301 million. The company employs around 1,900 staff of whom over 500 work in Nijmegen.
We are interested in result-oriented people with a sharp mind and entrepreneurial spirit, who can contribute to our ambition to provide solutions to the healthcare challenges of today and tomorrow.
In this role you will support the (clinical) development of our biopharmaceutical oncology products. You will design and supervise advanced laboratory studies. These studies are directly related to development and validation of various chromatographic and electrophoretic methods (e.g. content determinations and impurity tests), characterization of (intermediate) products and transfer of methods to internal and external quality control laboratories for our antibodies and antibody-drug conjugates. You will spend part of your time in the laboratory, working closely together with the analysts. In addition, you will lead root cause investigation teams, write technical sections of regulatory filings and responses to questions from health authorities. Finally, you will identify and implement emerging new analytical technologies that improve the quality and/or efficiency of our quality control methods.
You will work in an experienced and dedicated group of analysts and scientists for analytical method development. This group is part of a large analytical department and uses state-of-the-art facilities and equipment.
Your letter and CV will show that you have:
⦁ A master’s degree or Ph.D. in analytical chemistry or life sciences
⦁ At least 3 years of working experience, preferably in an industrial (pharmaceutical) environment
⦁ Demonstrable hands-on experience with HPLC/UPLC and/or capillary electrophoresis (preferably for large molecules)
⦁ In-depth experience with development and validation of separation methods (using QbD approaches and ICH Q2(R1)/Q6B)
⦁ Preferably knowledge of relevant regulatory guidelines and basic understanding of GMP requirements
⦁ A good command of the English language (in writing and speaking).
In interviews you will be able to demonstrate that:
You are a team player with good communication skills. You are used to working on multiple projects simultaneously. You take initiative to get tasks accomplished and you have the ability to meet challenging timelines.
Please send your application before 3 May 2019. The first round of interviews will take place on 17 May 2019. The second round of interviews will take place on 24 May 2019.
Contract hours: preferably full time.
Salary: depending on experience.
For further information, please contact Mark Eggink, group leader NBE Method Development Phys-Chem tel. +31 (0)24 372 77 00.
If you are interested in this challenging position, we look forward to your application via the apply button or link.