Quality Control Analyst Bioassay

About Synthon

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 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.

Job profile

As Quality Control technician bioassay you will execute complex cell-based binding assays to demonstrate biological potency as well as ELISA tests to control biological impurities such as host cell proteins. You will operate under a full GMP regime and your data will be used to support method validations, disposition of clinical and commercial materials (both drug substance and drug product) and regulatory filings. You are expected to work accurately and to critically review your data to identify potential technical issues related to analytical methods and/or associated critical reagents such as reference materials. You will write technical reports that may be used to support regulatory filings and audits.

You will be part of a large analytical department responsible for characterization and testing of all biopharmaceutical materials within Synthon. You will report directly to the group leader QC Cell-based Bioassays/EIA.

Your profile

Your qualifications are:
⦁ A bachelor’s degree in life sciences or equivalent
⦁ Demonstrable technical experience with cell culture and cell-based assays, including statistical analysis
⦁ Experience within a GMP quality control laboratory and regulations is a plus
⦁ Experience in validation/transfer of analytical methods for biologics is a plus
⦁ Good command of the English language (in writing and speaking).

In interviews you will be able to demonstrate that:
You possess excellent communication skills, you are flexible, pragmatic, accurate and service-/quality driven. You are experienced in the analytical methods required and you are able to cooperate with and support colleagues at various departments.

Important dates

Please send your application before 31 July 2019. The first round of interviews will take place on 8 August 2019 and the second round of interviews will take place on 13 August 2019.

Information and application

Contract type: temporary until October 2020.
Contract hours: preferably full time.
Salary: depending on experience.
Location: Nijmegen.

For further information, please contact Nicolette de Wijs-Rot, group leader QC Cell-based Bioassays/EIA at tel. +31 (0)24 372 77 00.
If you are interested in this challenging position, we look forward to your application. You can apply via the apply button or link, which will directly lead you to our website.

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