公司簡(jiǎn)介
諾華中國(guó)
所屬團(tuán)隊(duì)
職位屬性
- 招聘類型：社招
- 工作性質(zhì)：全職
職位描述
Leading chemical role in CHAD and member of Drug Substance (DS) Sub team defining fit-forpurpose synthesis strategy for drug substance manufacturing and Health Authority documentation. Key activities include driving synthesis and purification strategy for assigned development projects, while ensuring utilization of state-of-the-art technologies and science, efficient use of lab resources and maintaining oversight on process safety. They co-lead the process transfer to pilot plants and serve as consultants for troubleshooting during campaigns in collaboration with internal and external stakeholders or partners.
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
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任職條件
Materials Science
Process Simulation
Experiments Design
Standard Operating Procedure (SOP)
Environment
Coaching
Health And Safety (Ehs)
Manufacturing Processes
Laboratory Instrumentation
Technical Writing
Waterfall Model
Data Science