(Organic) Chemist / CMC Process Development Scientist

138071
  • 100000 EUR - 100000 EUR
  • Berlin, Germany
  • Permanent

 

Key Responsibilities

  • Develop and provide subject matter expertise on process development and manufacturing processes of siRNA molecules
  • Collect, interpret and communicate data generated from a variety of sources, including internal data/documents and external protocols, reports and batch records and based on that build internal knowledge about Silence’s processes of the manufacturing of oligonucleotides
  • Develop small-scale studies meant to develop process understanding, improve process robustness and/or efficiency, together with internal and/or external partners
  • Actively seek to improve the production principles for oligonucleotides by engaging with internal and external partners (scientific organisations, companies and other bodies) and monitoring new developments within the field
  • Act as liaison with both internal and external collaboration partners to ensure developed processes and designs are compatible with production principles to ensure seamless technical transfer for large scale productions
  • Write regulatory documentation for the CMC part of briefing books/INDs/IMPDs, and eventually for the registration file
  • Support the planning and execution of project-related activities, including budget planning
  • Contribute to development, optimisation and maintenance of processes, standards and systems within Silence Therapeutics, contribute to performing risk assessments
  • Support in Starting Materials/Raw Materials synthesis optimization and scale-up
  • Works to ensure that GMP manufacturing is conducted in compliance with relevant cGMP requirements for countries in which Silence’s products are used

Person Specification

You will be able to demonstrate the following competencies and behaviours:

  • PhD, in chemistry or other life science area
  • Preferred minimum of 5 years of experience in oligonucleotide, peptide and/or organic chemistry
  • Experience in process development of chemical manufacturing processes, preferably in solid phase synthesis
  • Experience in the pharmaceutical/biotech industry working, preferably working under GMP
  • Experience in preparing complex regulatory documents, including regulatory applications for clinical trials and briefing packages would be beneficial
  • Holds a passion for collaborative working, building relationships and excellent stakeholder management experience
  • A “can do” attitude, capable of working against challenging timelines keeping focus on value adding activities and strong interactive skills
  • Expertise in MS office applications and aptitude for grasping new applications
  • 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 spoken English
Mitja Gräfe Lead Consultant

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