Principal Scientist Msat Lm Dp Tli
vor 7 Monaten
Johnson and Johnson is recruiting for a Principal Scientist, LM DP Technical Launch Integrator, located in Schaffhausen, Switzerland.
The Principal Scientist - TLI has overall accountability to lead the coordination of tech transfer activities of pharmaceutical processes and products into the supply chain and the global marketplace, and for ensuring fit for plant and commercial readiness during technical development. Areas of key functions include DP technical support and oversight for supply chain, planning and execution of DP manufacturing and new product launch. The Technical Launch Integrator has the ability to shape, can work in close collaboration with other roles, and must have strong communication skills to influence other functions/levels outside of own group. In this role you will effectively lead global and cross organizational teams to generally attain desired results for all parties.
**Key Responsibilities**:
- Technical and manufacturing integration of new and re-developed Large Molecules drug products from R&D DPDS into the supply chain.
- Contribution, review and approval of drug product technical and regulatory documents, routine technical support during execution, integration of JSC technical expertise into project execution.
- Leads projects with deep scientific and technical expertise, analytical and manufacturing know-how, being a partner for R&D including the clinical supply chain
- Point of contact for JSC and/or Contract Manufacturing Organizations (CMOs) plant readiness and execution from technical transfer into commercial production including launch support
- Leading the DP manufacturing site team and manufacturing site representative on the R&D DPDS sub team and the Value Chain Management team and Site Virtual Management Team (VMT) at CMOs.
- Identifying and implementing opportunities for active decrease in DP COGs and partnering with R&D and JSC groups to develop and implement strategies to improve the fit for plant and commercialization of new products
- Partnering with the DPD-SI and API-SI to provide all DP manufacturing site related needs
- Providing required manufacturing technical support, document technical input, review and approval and serving as the JSC technical guide
- Coordinating and implementing product introduction at the site from DP transfer through launch covering raw materials, formula, process, packaging, and device integration into the bulk API and finished DP and supporting the VCL for site related launch activities
- Coordinating and implementing product site to site technology transfers
- Delivering clinical through commercial DP supply from the manufacturing site, ensuring manufacturing performance, cost, and process adaptability requirements are met
- Optimizing the new product introduction process, making use of JSC technology platforms, accelerating development timelines, and streamlining the technical transfer process
**Qualifications**:
**Qualifications**:
**Education**:
- A Bachelor's degree in sciences (biology, engineering, etc.) and/or equivalent degree required; M.S.or PhD preferred
**Experience and Skills**:
**Required**:
- A minimum 8 years of relevant work experience
- Experience with introduction of pharmaceutical products to manufacturing sites and late state development with robust technical knowledge of manufacturing site unit operations
- Ability to influence and lead peers, superiors, and external partners.
- Knowledge of both pharmaceutical product R&D and Technical Operations functions and experience with large molecules; experience with small molecules is a plus.
- Supporting resolution of technical issues and growing strategies and proposals to pertinent partners/SMEs and working towards assure Compliance and Quality execution.
- Planning and logistics skills capable of effective integration of DP deliverables and support detailed execution
- Ability to foster team efficiency and cohesiveness and to work collaboratively to execute, deliver and get results through the various matrix teams
- Ability to influence and communicate laterally and up and down the ladder. Experience with stakeholder management and managing global teams
- Efficient, flexible, dynamic, results, performance driven and capable to manage projects with conflicting priorities.
- Good project management and communication skills.
**Preferred**:
- Experience with document management systems, e.g. TruVault.
- Experience with business support systems ;Trackwise, SAP, Planisware, etc.
- Expertise with combination products and different types of drug delivery devices
**Other**:
- Fluent in written and spoken English
- The ability to travel up to 25% of the time as an estimate, domestic and international
At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health
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