Join our dedicated team

Specialized team of scientists

BSL 2 & BSL 3 Facilities

Large Scale Diagnostic Services

Specialized Consultancy Services

NEWS

ViroSpot MN assay, a novel tool for antigenic characterization of influenza viruses and serology.
The ViroSpot assay platform is currently available for influenza virus and RSV, and under development for multiple other viral targets.

Virology Contract Research Laboratory

Specialized team of scientists

BSL 2 & BSL 3 Facilities

Large Scale Diagnostic Services

Specialized Consultancy Services

NEWS

ViroSpot MN assay, a novel tool for antigenic characterization of influenza viruses and serology.
The ViroSpot assay platform is currently available for influenza virus and RSV, and under development for multiple other viral targets.

Vacancy

Are you looking for a challenging position within Clinical Virology? Are you motivated to achieve and eager to learn? Then we might have a vacancy for you! Currently we are looking for a:

 

Bioanalytical Assay Implementation and Regulatory Specialist

Tasks

In this position, you will be guiding the implementation of assays in the fields of virology and anti-viral immune responses into the production phase, making sure the assay is fit-for-purpose in clinical projects and meeting the FDA and EMA standards for clinical trial testing. In this position you guide the transition of bioanalytical assays from R&D to the production phase, in close collaboration with the departments of Clinical Virology Services and R&D. As such, you will be working in the Clinical Virology Services department of Viroclinics Biosciences, which currently consists of a director, 2 managers, 5 group leaders and a core team of technicians. You will be working at the Rotterdam Science Tower, where our head office is based.

The following tasks will be a part of your responsibilities:

  • Ensure that bioanalytical assay qualification, validation and other life cycle activities are compliant with company quality policies and procedures and regulatory agencies;
  • Explaining regulations, procedures, and policies to all employees and stakeholders as necessary;
  • Manage and continually improve the process of assay transfer from R&D to the production phase;
  • Regularly reporting on compliance status with respect to requirements from internal and external clients and regulatory agencies;
  • Analyze assay performance and write proposals to improve performance where necessary;
  • Standardize all business operations with respect to assay lifecycle and establish clear, documented protocols;
  • Reviewing technical documentation (including case files and clinical research reports) to assess compliance with company quality policies and procedures and regulatory agencies;
  • Act as a major contact during regulatory and third party audits.

Personal competences

We are looking for a colleague with the following skills and competences:

  • MSc or PhD in Life Sciences and/or relevant clinical experience in pharma setting;
  • Demonstrated understanding of the requirements for setting up assays meeting FDA and EMA requirements and matching assay grade with customers clinical trials in different stages of clinical development (phase 1-4);
  • Expertise with relevant statistical methods for assay validation;
  • Excellent oral and written communication skills;
  • Ability to work well as part of a multidisciplinary team as well as independently;
  • Excellent IT skills, primarily Office (Word, PowerPoint Excel), LIMS and document control software packages;
  • Organizational skills and the ability to prioritize tasks in response to unexpected opportunities or risks.

Terms of employment

Bioanalytical Assay Implementation and Regulatory Specialist is a new position for 32-40 hours a week. We offer you a salary that corresponds with your education, experience and our company policy. We offer you a one-year contract with the possibility of extension and a permanent contract upon good performance. Furthermore, you will receive 8% holiday allowance and travel allowance.

Viroclinics-DDL is committed to the development of its employees. You will have access to general  and job related training courses. In consultation with your supervisor, we will provide you with the opportunity to join external courses and training.

Company Profile

Working at Viroclinics-DDL means working for a leading laboratory where samples of various viruses are analyzed. We are specialized in serological, virological and molecular assays and we work with many different viruses, such as: SARS-CoV-2, Rabies, Human papillomavirus (HPV), Hepatitis viruses (HBV and HCV), Respiratory infections (RSV, Rhinovirus, Influenza virus), Herpesviruses (CMV, EBV, VZV, HSV), Poliovirus.

Our clients are global pharmaceutical and biotech companies. Viroclinics-DDL is known for delivering top quality through our extensive virological knowledge.

With more than 300 employees we are working on global vaccine and antiviral development programs. You will be joining a diverse, social, dynamic and highly motivated team of professionals. Our facility are located at Rotterdam, Rijswijk and Schaijk. We are always looking for new talent to expand our team of professionals. If we have raised your interest in joining our team, please feel free to contact us!

 

To apply fort his position

Would you like to be a part of our Clinical Virology team as Bioanalytical Assay Implementation and Regulatory Specialist? Please send your CV and motivation letter to Madri Singh, Corporate Recruiter, via recruitment@viroclinics.com. For further information about the vacancy, please contact us at +31657389380.

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