摘要
~设计,计划,执行,解释和报告科学实验结果,以制备和及时交付原料药(DS),药品(DP),流程和程序。 领导和管理所有项目/本地网络活动,支持/指导团队成员,参与子团队并为整体TRD战略和目标做出贡献~管理轨道~领导一个团队,在多学科环境中开发药物/生物/细胞基因疗法。执行并支持制定职能战略,并根据TRD的愿景和战略推动卓越运营。确保根据GDD、山德士、NTO和NIBR计划提供全面的产品组合支持。
~山德士:
~团队负责人:~领导和管理一个团队,根据全球技术发展战略和目标开发通用产品、流程和程序;应用科学/技术/GMP和/或质量相关专业知识来解决复杂的研发问题;教练团队成员;管理实验室或工厂的运营方面;制定科学技术战略~(首席)科学家:领导和管理所有项目/本地网络活动,并为战略决策做出贡献;设计,计划,执行,~记录和解释科学/开发实验或GMP测试或中试工厂过程,以便在项目经理/负责人协调的多功能项目团队中准备和及时交付通用产品,过程或程序;维护和鉴定设备/基础设施,并按照分配管理实验室或工厂的运营方面。
~科学家:~设计,计划,执行,解释和报告科学实验结果,以开发和及时交付药品(DP),流程和程序。 领导和管理所有项目/本地网络活动,支持/指导团队成员,参与子团队并为深圳的整体战略和目标做出贡献。
About the Role
Key responsibilities:
- All objectives for development projects assigned fully met or exceeded, including timely, availability of synthesis and manufacturing processes and quality of DS, process safety, etc.
- TRD project strategy fully aligned, e.g., within CHAD, or NCE, and fully supported by DS Sub team
- All relevant source documentation provided right-first-time within project timelines supporting submissions throughout development phases, according to latest compliance rules, following approved business processes (GMP, HSE, iDevGuide) and meet expectations of Health Authorities, e.g., regarding quality and patient safety.
- All assigned lab resources from the CDUs and Technology platforms utilized efficiently in the best interest of the project and CHAD organization. DS Sub team works efficiently and with respect to Novartis V&Bs
- Positive customer satisfaction received from project teams and network members, with regards to quality, timelines and oversight
- Responsible to design, plan, interpret scientific experiments and provide summaries and reports supporting team discussions and decisions
- Responsible to deliver efficient, robust and safe manufacturing strategies and processes for the manufacture of intermediates and DS for assigned development projects as per project requirements and development phase (e.g. early, late, accelerated)
- Responsible to plan work for assigned lab associates ensuring their efficient utilization in the best interest of the project and CHAD organization with clear priority setting and adequate level of supervision also considering the expertise, functional level and experience of assigned lab associates
- Responsible to report and present scientific/technical results internally (projects, networks and/or platforms), externally (CRO/CDMO) and contribute to publications, presentations and patents
- Responsible to author, review and/or approve GMP/registration-relevant source documents (e.g. SYN, MAT, NOS, NSR, CER, etc.) and select most appropriate scientific documents to hand over to internal and/or external partners (ChemOps, health authorities, 3rd parties) and ensure quality of international registration documents
- Interact/collaborate with Research and/or other GDD functions to facilitate transfer of knowledge and delivery of DS
- Responsible to ensure and contribute to a collaborative and target oriented work environment with DS sub teams in line with NVS Values and Behaviors, e.g. collaboration with DS Project Leader, CHAD and ARD analytics, LSC team, CRO / CDMO project teams etc
Essential requiremernts:
- Ph.D. in chemistry or pharma or equivalent
- Good knowledge of English (oral and written). Desirable knowledge of site language
- Successfully demonstrated several years (minimum of 3 years) of directly related experience as fellow or equivalent
- Recognized expertise in a specific area and broader scientific as well as strategic background
- Proven track record of creativity, problem solving and productivity in projects.Good overview of current trends and upcoming techniques for current and future applications
- Thorough understanding of development process- es in TRD
- Demonstrated successful experience with working in interdisciplinary and cross-cultural teams. Excellent leadership skills
- Thorough knowledge of relevant SOP, GMP and Novartis regulations and policies
- Excellent communication/presentation skills and scientific/technical writing skills. Advanced coaching and mentoring skills
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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Innovative Medicines
Changshu (Jiangsu Province)
CN23 (FCRS = CN023) Suzhou Novartis Technical Development Co., Ltd.
Research & Development
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