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(Organic) Chemist / Starting Materials Manufacturing Manager
10.01.2024 / Silence Therapeutics GmbH seeks (Organic) Chemist / Starting Materials Manufacturing Manager
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.
The role is part of a growing team within CMC Manufacturing of Oligonucleotides. The Starting Materials Manufacturing Manager is a cross functional role that will also serve as a key member of the drug development project teams. The role mainly focuses on providing operational support to the CMC team, with as main area of responsibility the chemically synthesized proprietary starting materials used in the synthesis of our oligonucleotides. In addition, it includes support of supply chain management of these proprietary starting materials.
Experience in organic and/or analytical chemistry or in pharmaceutical development will be essential.Working experience managing Contract Manufacturing Organizations (CMOs) would be beneficial. Additional knowledge of supply chain and logistics management, preferably in a biotech or research organisation will be also beneficial. This position is a full-time position working at our Berlin site (with partial home-office possible). It is a varied role in a multicultural environment.
- Support process development and optimization as well as scale up and manufacturing activities of the chemically synthesized starting materials in collaboration with our Contract Manufacturing Organisations (CMO’s).
- Organize meetings with CMO’s, drafting meeting minutes, literature research, reviewing reports, use reports to support drafting of regulatory documents.
- When appropriate, participate in on-site visits at CMOs to ensure services provided are meeting Silence’s expectations.
- Interpret and communicate data generated from a variety of sources, including internal data/documents and external batch/process records.
- Prepare and manage international shipments of the starting materials
- Manage forecasting process for Silence’s proprietary starting materials and ensure timely execution of the manufacturing plan.
- Support Starting Material Inventory management and reconciliation.
- Support the planning and execution of project related activities, including budget planning and material forecasting.
- Ensure requirements outlined in relevant contractual obligations (e.g MSAs and QTAs) with CMOs are met.
- In cooperation with Silence Quality Assurance, ensure that appropriate quality standards at CMOs are maintained.
- Contribute to development, optimisation and maintenance of general processes, standards and systems within CMC Manufacturing
- A relevant university degree in chemistry or other life science area
- Preferably minimum 5 years experience in a relevant field in the pharmaceutical/biotech industry or in an academic setting
- Experience in organic chemistry, peptide chemistry or, oligonucleotides
- Experience in managing Contract Manufacturing Organizations (CMOs) would be beneficial
- Previous administrative experience in logistics and/or supply chain management would be advantageous
- A “can do” attitude, capable of working against challenging timelines keeping focus on value adding activities.
- Strong communication and influencing skills.
- Aptitude in business and financial planning.
- Ability to adapt to and navigate different cultural expectations with overseas CMOs.
- Competency in operationalizing legal agreements to ensure adherence.
- 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
- 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 in English
- Holds a passion for collaborative working, building relationships and excellent stakeholder management experience.
If this sounds like the job for you, please send your cv and a cover letter to HR@silence-therapeutics.comSilence Therapeutics GmbH seeks (Organic) Chemist / Starting Materials Manufacturing Manager