Our client, a dynamic global bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for a Senior Scientist with experience in MSAT on a contract basis in the German speaking part of Switzerland.
The ideal candidate should have Scientific background and have experience ein technical development of drugs and execution of the transfer of pharmaceutical processes and products from Development into the supply chain and the global market place
Areas of key responsibility include Drug Product sourcing & technical support and oversight for the supply chain, planning and execution of Drug Product production, and manufacturing site level support of new product launch. This person is a member of the Manufacturing Site Operational teams, CMC Sub Team, and JSC ( Supply chain) Value Chain Team and leads the new product introduction team at the manufacturing site.
- Technical and manufacturing integration of new and re-developed drug products from R&D (DPDS or VPAD) into the supply chain by keeping Best Process/Product at Launch (BPAL) mindset.
- Contribution, review and approval of drug product technical and regulatory documents, routine technical support, integration of JSC/MSAT technical expertise of proven and matured (new and existing) technologies into project execution and QbD technical implementation at the manufacturing site level.
- Single point of contact for JSC plant readiness and execution from technical transfer into commercial production including launch support.
- Leading the manufacturing site team and taking the role of manufacturing site representative on the CMC Sub Team and the Value Chain Team (VCT).
- Identifying and implementing opportunities for active decrease of COGs and partnering with Development and JSC groups to develop and implement strategies to improve process robustness, fit for plant and commercialization of new products into the supply chain.
- Provide all manufacturing site related needs to the CMC Sub Team as the single point of contact at the site.
- Developing the manufacturing site execution plan per product, in line with the overall strategy and plan as outlined by the CMC Sub Team and JSC VCT. The TLI will ensure alignment and endorsement of this strategy within the manufacturing site and TLI function.
- Providing required manufacturing technical support, document technical input, review and approval and serving as the JSC technical expert.
- Coordinating and executing product introduction at the site from sourcing & transfer through launch covering raw materials, formula, process, packaging and device integration into the finished product and supporting the Value Chain Lead (VCL) for site related launch activities.
- Delivering clinical through commercial product supplied by the manufacturing site, ensuring manufacturing performance, cost, and process robustness requirements are met.
- Optimizing the new product introduction process, making use of JSC technology platforms, accelerating development timelines, streamlining the technical transfer process.
- Serving as the Supply Chain technical representative on the CMC Sub Team, site representative on the VCT, and leader of the product specific site team.
Qualifications and Experience:
- Relevant working/residency permit or Swiss/EU-Citizenship required.
- BS/BA with experience in pharmaceutical development or pharmaceutical manufacturing or related post graduate academic experience/education.
- Knowledge of both pharmaceutical product R&D and Manufacturing / Technical Operations functions
- Knowledge of manufacturing & digital technologies, aseptic processing & development processes in LM Drug Product manufacturing
- Planning and logistics skills capable of effective integration of DP deliverables to support detailed execution at the manufacturing site level.
- Experience with introduction of pharmaceutical products to manufacturing sites and late stage development with technical knowledge of manufacturing site unit operations.
- Knowledge of manufacturing site systems and procedures; understanding of GMP requirements
- Document mgmt. systems such as RIMdocs, TruVault, SAP, MS Office applications Trackwise Planisware
- Demonstrated leadership in providing integration of activities and information across multi-functional groups and matrix teams.
- Ability to foster team productivity and cohesiveness and to work collaboratively to execute, deliver and get results through the various matrix teams.
- Ability to influence peers, superiors, and partners.
- Motivated, self-starter able to work independently with demonstrated problem solving skills.