Gene therapy is going viral
Over de functie
Yacht Life Sciences has a vacancy for a Laboratory Technician Bio-Analytical Development.
Due to the increased number of projects Analytical and Non-Clinical Development our partner is engaged in, we are now actively recruiting for a Technician Bio analytical Development to complement their Bioanalytical team. The primary focus will be on the development and qualification of bio-analytical methods for the assessment of pharmacokinetic, safety and pharmacodynamic parameters. In addition to hands-on development work, the Technician will also actively partake in analysis of preclinical and non-clinical sample using the aforementioned methods. We look for a candidate that is a team player, enthusiastic and resourceful, with good analytical and problem-solving skills, capable of working very accurate and has a can-do attitude. The ideal candidate has been trained and has relevant working experience with development/qualification of techniques used in the field of both molecular biology and immunology/cellular biology. The role should be filled on an ASAP basis.
Analytical and Non-Clinical Development departments are instrumental in assuring the quality, safety and efficacy of our partner's virus-based products towards clinical use and marketing authorization. Analytical Development is responsible for developing product-specific assays to support product testing and release, and the development and validation of bio-analytical assays to monitor safety and efficacy during clinical development. Non-clinical safety programs entail testing for efficacy and potential safety risks, in compliance with regulatory requirements. They are crucial for evaluating the benefit-to-risk ratio of our partner's products, also with respect to environmental safety.
Within the Bio-analytics team, the Technician will develop and qualify of analytical methods for the assessment of pharmacokinetic, safety and pharmacodynamic parameters. In the case of gene therapy, this may encompass assays to determine presence of vector DNA / transgenic transcript(s), assays to determine immunogenicity of the vector and/or the gene product, and assays to determine efficacy using appropriate pharmacodynamic biomarkers.
In this function primary focus will be on development and qualification of bio-analytical methods. Furthermore, besides hands-on development work, the Technician will also actively partake in analysis of preclinical and non-clinical samples using the aforementioned methods.
Main Purpose of the job:
- Establish scientifically sound and quality compliant bio-analytical methods to support the preclinical-, nonclinical- and clinical development programs (hands-on)
- Proper planning of analytical work to ensure maximum efficacy
- Execute comprehensive analysis on preclinical- and nonclinical- study sample sets (hands-on)
- Document and report bio-analytical data, in line with GLP practices, wherever and whenever appropriate
- To establish relevant quality documentation (analytical procedures, analytical development reports)
- Master’s degree in life sciences-related field with minimum 2 years’ relevant experience in a comparable position, preferably in the field of (bio-) pharmaceuticals, gene therapy and/or vaccines, or Bachelor’s degree in life sciences-related field with minimum 5 years’ relevant experience in a comparable position, preferably in the field of (bio-) pharmaceuticals, gene therapy and/or vaccines.
- Experience and active knowledge in relation to immunological assays including neutralization assays (such as Neutralizing Antibody Assay) and ELISPOT is preferred
- Experience and active knowledge in relation to standard bio-analytical methods (e.g. quantitative polymerase chain reaction-based analysis (qPCR), (RT)qPCR and ELISA) is preferred
- Hands-on experience in bio-analytical analysis, affinity with good laboratory practice (GLP)
- Experience in bio-analytical assay development, preferably in the area of biologics, gene therapy or vaccines.
- Hands-on experience in the handling and prepping of biological samples under Microbiological Safety Level II restrictions.
- Excellent knowledge of the English language (verbal and written)
- Integer: accurate, dependable, proactive
- Thorough: ability to carry out tasks with an eye for completeness (e.g. results achieved according to agreed AIMs and/or protocols, results discussed with team members, issues identified and resolved
- Self-organised: ability to focus and to plan appropriately
- Detail-oriented: analytical mindset, ability to identify important details
- Problem solving: ability to identify problems (assay performance, equipment, or test results), discuss these within the team, and to find a solution
- Co-operative: ability to work within a team and with other teams to drive projects forward according to agreed time lines
This concerns a temporary position (maternity leave cover) for 7 months at our partner, but a 1 year contract will be given by Yacht if appointed for this role. We will offer a competitive benefits package in line with the seniority of the position. You will become a member of a strong professional network who shares your education, ambitions and competencies. This will enable you to interact with your colleagues and become a member of the YACHT network, which stretches the Life Science industry. You will be challenged by your peers and will be able to follow courses and training via our Yacht Academy and keep your knowledge and skills up-to-date: boosting your career through personal and scientific growth.
Our partner is dedicated to bringing therapies for unmet medical needs to patients. In doing so each function is directly or indirectly responsible for the lives of patients. This responsibility should be part of our day-to-day working life (i) by living up to high quality standards and (ii) by recognizing the sense of urgency in areas of high medical need.
Analytical Development is covering important areas in generating value of AAV-based products. First, the department is responsible for developing, qualifying and implementing product specific assays to ensure the quality of their products, and to monitor analytical method performance and provide continued analytical support during routine testing. Such analytical development also includes extended product characterization, generating and qualifying (early) reference standards, spec setting. Second, the department is responsible for the analysis of samples coming from manufacturing campaigns for R&D products and generating data that is subsequently used to qualify product used for preclinical/ nonclinical testing or used to make decisions in process development. Further, the department develops and implements assays to monitor function and safety of its products during clinical development and beyond MAA. Finally, the department is responsible for formulation development, and performing drug product characterization, (early) stability assessment, and compatibility assessment.
Phase I-II Assay Development is responsible for developing and implementing product specific assays to ensure the quality of the products. Those activities are supporting the whole scope of AAV product development, especially Process-, Non-clinical and Clinical development. The group is responsible for proper transfer of assays and know-how to AD Lexington and the Quality Control Department.
Phase I-II Assay development also has to ensure that assays to be developed and implemented meet the appropriate legislation and follow internal quality standards. This requires active interaction with the Regulatory and the Quality Assurance departments.
Voor meer informatie neem je contact op met Thomas Rijpma via telefoonnummer 06-82503655
Werken voor Yacht
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Uiteraard staat deze vacature open voor zowel mannen als vrouwen.