Technician Bio-Analytical Development

Seuss Recruitment BV

The Technician will develop and qualify analytical methods for assessment ,

  • Biotech
  • Technician
  • Bio-Analytical Development
Technician Bio-Analytical Development
 
Our client is dedicated to bringing innovative therapies or 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 by (i) living up to high quality standards and (ii) by recognizing the sense of urgency in areas of high medical need.
 
Due to the increased number of projects Analytical and Non-Clinical Development are engaged in, we are now actively recruiting for a Technician Bio analytical Development to complement the 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 AAV-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 client’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)
 
Qualifications
  • 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, preferably 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).
 
 
 Competencies
  • 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 timelines