Our client, Synthon Biopharmaceuticals, focuses on development of innovative medicines, including antibody-drug conjugates, in two key therapeutic areas: oncology and autoimmune diseases. In the coming years, they aim to deliver on our promise to introduce new medicines for diseases with high unmet medical need.
They are inquisitive, entrepreneurial and independent. Synthon Biopharmaceuticals makes creative choices, and are building a promising portfolio of next-generation medicines.
Synthon Biopharmaceuticals is based in Nijmegen, the Netherlands, where over 250 staff work at our state-of-the art biotech campus.
They 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.
Synthon Biopharmaceuticals obtained a GMP license to manufacture antibody-drug conjugates in its new high-containment GMP clean room facility in Nijmegen. Synthon is also well on its way with the construction of a new state-of-the-art GMP plant to produce monoclonal antibodies using mammalian cell culture. Both facilities will be used to produce drug substances to support their clinical studies and future commercial supplies.
In this role you will support the QP Synthon BIO with relevant quality issues. You will prepare batch release for the QP. Furthermore, you will participate in CMC meetings to support product development within Synthon BIO.
Your responsibilities include:
- Releasing drug Intermediates and preparing batch release in close cooperation with QP.
- Participating in CMC meetings.
- Reviewing and approving QA documentation such as validation protocols and reports, risk assessment, procedures, work instructions, etc. Providing an excellent advisory service to production and R&D departments (QbD) for QA related systems.
- Participating on behalf of QA in the setup of new quality related systems from a biopharmaceutical point of view.
- Advising Synthon BIO on the implementation of new and revised guidelines (Eudralex, ICH, CFR,…)
- Writing, maintaining, approving procedures for Synthon BIO, when needed.
- Performing internal and external audits and support on critical external audits from customers and/ or authorities.
- level of experience and education: HBO/bachelor;
- a minimum of 5 years of GMP-work experience in the biopharmaceutical industry, e.g. QA, QC, production;
- QA experience;
- knowledge of the regulatory requirements to enable assessment of the applicability and compliance with such laws, regulations, and standards;
- excellent verbal and written communication skills and an outstanding command of the English language;
- Biotechnological knowledge and experience with development of new medicines.
06 – 13 56 19 88 | email@example.com
Maike Goossens | Recruitment Specialist
06 – 12 20 45 14 | firstname.lastname@example.org