Senior Scientist Analytical Development & Quality Control at ProQR Therapeutics
ProQR Therapeutics is a clinical-stage biotech company listed on NASDAQ with offices in Leiden, the Netherlands and Cambridge, MA, US. ProQR is focused on the development of game changing RNA therapies for severe genetic rare diseases. Our mission is to help patients by creating new medicines. A team of 140 ProQRians from all walks of life and more than 30 different nationalities is up to this challenge. We have the passion and commitment to make a difference in the lives of the patients we serve.
The Chemistry, Manufacturing and Control (CMC) Department has a central role within the ProQR Therapeutics organization. The CMC Department develops, manufactures and characterizes oligonucleotides and therapeutic formulations for clinical development and commercialization.
We are looking for an experienced analytical scientist who is able to develop and validate analytical methods to characterize and release our drug substances and drug products. The Senior Scientist will work closely together with CROs and CMOs and takes care of quality control activities. The Senior Scientist has a creative mindset and has affinity with drug substance and drug product characterization, assay/purity measurements, validation, QC and, GxMP.
- Ability to supervise internal and external analytical development and quality control projects
- Having knowledge of GMP and knowledge of relevant regulatory guidelines
- Ability to develop and validate assay and purity analysis of oligonucleotide products
- Participating in IND/NDA writing
- Ability to ensure that the latest internal and external knowledge is used in order to improve processes and quality
- Ability to balance between creative, effective method development and the rules of GMP
Theoretical knowledge and/or hands-on experience in the following fields:
- Pharm. Eur., USP and ICH quality guidelines applicable to AD/QC
- LC-MS and advanced mass spectrometric characterization
- Chromatography, UPLC and HPLC
- Basic analytical assays and pharmacopoeia analysis
- Analytical chemical knowledge of oligonucleotides is a pre
We expect our senior scientist:
- to have good communication skills to work with external partners/CROs/CMOs on analytical method development and quality control
- to actively build and manage an internal and external network in the analytical science area and acts as a focal point for both internal and external stakeholders
- to supervise a number of projects and activities to ensure delivery of high quality results according to plan and within budget
- to participate in IND/NDA writing
- to process raw data and write protocols and reports
- to keep the existing methods and protocols up to date
- to participate in multi-disciplinary project teams
- to participate in expanding ProQR’s in house development lab capabilities
Competencies that are required for making the difference
- Having an academic level - preferably analytical chemistry and at least five years of working experience in a business environment, preferably within a pharmaceutical or biotech company or a contract research laboratory
- A pro-active and a pragmatic self-starter, with a result-oriented mindset
- Having the continuous drive to improve him- or herself as well as the team
- Excellent communication skills
- Being accurate and quality aware
- Having hands on mentality
- Being flexible and resistant to continuous change
- Having the ability to work under pressure
- Excellent knowledge of spoken and written English
- Fulltime availability
- A nice person :-)
We offer an exciting and innovative working environment, great colleagues, a competitive salary and a lot of fun.
Do you want to be part of our devoted team of enthusiastic professionals? Do you think you can contribute in achieving our mission? Do you want to work in a challenging environment where your work can really make a difference? If so, we’re looking forward to receive your application by filling out our application form.
Please apply as soon as possible, but before December 13th 2018, by filling out our application form.
Please note that a screening is part of our selection procedure.