Clinical Bio-Academic QA/QC Officer

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Are you passionate about advancing medical innovation and contributing to the development of new drugs within an academic setting? Do you have experience in ensuring quality and regulatory compliance within bio-academic research environments, particularly focused on pharmaceutical product manufacturing? Are you excited about working on the development, quality assurance, and regulation of challenge agents for use in controlled human infection models (CHIM), aimed at testing new vaccines and medication against infectious diseases? If so, we would like to meet you!

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About your role

As a clinical bio-academic QA/QC officer at the Leiden University Medical Center (LUMC), you will play an essential role in promoting medical innovation by focusing on the development, quality assurance, and regulation of challenge agents for use in CHIM. In close collaboration with a dynamic and diverse team of both young and experienced professionals, you will work on the production of various challenge agents, such as viruses, bacteria, and parasites. You will be involved in both small-scale internal projects and large international research consortia, collaborating with various stakeholders, including researchers, physicians, pharmacists, and production staff. You will contribute to the development of new innovative drugs, particularly cell and gene therapies, crucial for testing new vaccines and medication against infectious diseases. As an expert in quality control and regulation, you will ensure that all production processes meet the highest standards and guidelines. You will work closely with internal and external partners to ensure that all activities are in compliance with applicable laws and regulations. In this role, you will contribute to groundbreaking research and participate in the development of new drugs that can have a global impact on the health and well-being of people.

About you

• A completed MSc or PhD degree in the field of biomedical, pharmaceutical, or similar disciplines.
• Strong communication skills, both orally and in writing.
• Excellent project management skills, with a focus on accuracy and goal orientation.
• Demonstrated interest and/or experience in production, quality control, and regulation related to challenge agents, such as viruses, bacteria, and/or parasites.
• Preferably experience working within a Good Manufacturing Practice (GMP) certified environment, or willingness to learn.

Our offer

Driven by health; that's our mission. This applies not only to our patients but also to our employees. With Future@Work, we guarantee a pleasant working environment and provide room for development. In order to be able to continue to learn and develop, we offer internal and external training. You are also entitled to an end-of-year bonus (8,3%), holiday allowance, sports budget and bicycle scheme. Furthermore, as an employee of LUMC, you are also affiliated with the ABP pension fund. This means that 70% of your pension premium is paid by LUMC, leaving you with a higher net salary. Nice, right?

About your workplace

The Center for Cell and Gene Therapy (CCG) is an independent research facility within the LUMC, with over 20 years of experience in developing and producing cell and gene therapies and challenge agents. You will join a dynamic and diverse team of approximately ten professionals, both young and experienced, who are involved in the production and development of these products. Within this center, we support researchers in product development and are responsible for production in our GMP facility. Additionally, we serve as an expertise center in the field of regulation for both challenge agents and cell and gene therapy products.

What do we represent?

Our health is our greatest asset. Unlike any other profession, in healthcare, you can fully appreciate the entire spectrum of humanity in all its breadth. LUMC, as an academic medical center, wholeheartedly embraces that diversity! We strive for the highest quality in healthcare, education, and (international) research. We aim to be a creative and inspiring workplace. It is essential that everyone feels at home, safe, and recognized. That is why the LUMC was the first academic medical center to partner with

. Our active network, LUMC Pride, is dedicated to optimal inclusivity and diversity within our organization. Regardless of origin, gender, appearance, age, identity, orientation, (physical) disability, or faith, you are a valuable part of our organization. Together, we are LUMC.

More information

• As a clinical bio-academic QA/QC officer your salary ranges from a minimum of €4.678,- to a maximum of €6.402,- (scale 11, CAO UMC). These figures are based on full-time employment.
• Applications from employment/recruitment agencies will not be considered.

Links

Contact

Pauline Meij, Head of the Center for Cell and Gene Therapy, CCG department
Eileen van der Stoep, Hospital Pharmacist, CCG department
meer...

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