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Silence Therapeutics GmbH

Senior Scientist II, Quality Control

06.12.2023 / Silence Therapeutics GmbH seeks Senior Scientist II, Quality Control

Our 20-plus years of RNAi experience together with our validated mRNAi GOLD™ platform make us a partner of choice for pharmaceutical companies looking to access the benefits of the siRNA and add this revolutionary modality to their discovery pipeline. As pioneers in the design and development of siRNAs (short interfering RNAs), Silence Therapeutics is advancing a new generation of medicines to potentially address the needs of patients who have limited or inadequate treatment options. 

Our mission is to use our technology to create a new generation of therapeutics that can improve patient outcomes and, in the process, build shareholder value. 

We are developing a deep pipeline of innovative siRNAs based on our mRNAi GOLD™ platform for diseases with a genetic basis. The depth and versatility of our liver-targeting technology gives us the opportunity to address a wide range of conditions in virtually any therapeutic area. Our wholly-owned pipeline is currently focused in three therapeutic areas of high unmet need: hematology, cardiovascular, and rare diseases.  

Role Purpose

Silence Therapeutics is growing its Chemistry Manufacturing and Control team (CMC) to support our evolving pipeline and maturing approach to GMP Compliance. As a result, there is a need to broaden our competencies in Analytics and Quality Control methodologies for siRNA-based therapeutics. As Senior Scientist II, Quality Control, you will be joining the growing CMC GMP Quality Team  while being an integral being part of the broader Analytical community in CMC. You will guide and oversee development of new analytical methods including all aspects of the method lifecycle including method transfer to our CROs and CMOs, validation and ongoing monitoring. You will provide Quality level oversight to analytical activities performed at our CMOs related to GMP manufacturing and assist in resolution of issues related to analytics.  Additionally, you will serve as a GMP subject matter expert resource for all topics related to analytics providing guidance to other Silence team members in product and impurity characterization, method development and transfer. Finally, you will support development of documentation enabling successful Regulatory submissions to help mature our pipeline and move important therapeutics closer to market.

Key Responsibilities

  • Provide subject matter expertise in analytics and GMP QC practices for raw materials and siRNA compounds.
  • Responsible for delivery of analytical methods to support drug development and eventual commercialisation of product using state-of-the-art scientific principles at the right quality and at a manageable cost.
  • Review and Approve Method Development, Transfer and Validation Documentation.
  • Develop Stability Protocols for therapeutic products based on industry guidance
  • Review and Approve OOS/OOTs from CMOs
  • Contribute analytical expertise to Deviation investigations
  • Lead development of analytical control strategies
  • Lead Committee responsible for establishment of specifications. Execution of project related activities on-time and within budget
  • Generation and archiving of  CMC regulatory documentation for the analytical sections of INDs/IMPDs, briefing documents, and eventually for the registration file. Provide support during scientific advice meetings with regulatory authorities.
  • Participate in Audits where QC activities are in scope
  • Represent Silence in industry forums and health authority inspections

Person Specification

The QC Senior Scientist II will be able to demonstrate the following competencies and behaviours:

  • Advanced Degree (PhD preferred) in Chemistry or Biochemistry with experience in chromatographic and spectrometric methods for the characterization of molecules (oligonucleotides / peptides / biologics)
  • Minimum 7 years hands-on experience working in a GMP Quality Control laboratory supporting testing of clinical or commercial therapeutics for human use
  • Broad hands-on experience in analytical method lifecycle (HPLC MS and UV) including method development, qualification transfer and monitoring
  • Experience in the establishment and maintenance of stability studies for therapeutic products.
  • Experience in working with CROs/CMOs considered a plus
  • Strong collaborator and team player
  • Has a desire to broaden their experience and add value to our growing organisation
  • Clear affiliation with our vision and values, and a true ambassador of our organisation
  • Fluent in English
  • Fluent German would be advantageous but not essential
  • Clear affiliation with our vision and values, and a true ambassador of our organisation
  • Proven ability to effectively prioritise workload and strong organisational skills
  • Strong attention to detail and pride in the quality of their work
  • Excellent written and verbal communication skills

If you are interest in the role please apply to hrgermany@silenc-therapeutics.com

Silence Therapeutics GmbH

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