(Organic) Chemist
vor 6 Monaten
100000 EUR - 100000 EUR
- Berlin, Germany
- Permanent
**Key Responsibilities**:
- 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
- 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
- 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
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