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.
- 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
- 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.