Technical Manager 上海

月薪： 1.5-2万/月

该公司所有职位
  • 无工作经验
  • 本科
  • 招1人
  • 11-09 发布

职位描述

职位描述： Job Purpose:Lead and manage all Manufacturing Science & Technology activities for the assigned Supplier Relationship Team (SRT) / Contract Manufacturing Organizations (CMOs). This includes, providing product stewardship by ensuring the performance of all NVS products are monitored and maintained in a validated state, supporting root cause investigations by providing MS&T intelligence to deviations, technical complaints, OOS & CAPAs, identifying and executing continuous improvement opportunities, leading New Product Launch technical teams and leading technical activities related to transfers of Drug Product Manufacture and Packaging; depending on functional area of expertise.The Technical Manager will support the MS&T organization by leading initiatives and/or work-streams and representing ESO MS&T in various global networks.Major AccountabilitiesThe Technical Manager can be assigned to one specific role or combine several, depending on the size of his/her portfolio (e.g. Technical Manager – Product Steward, or Technical Manager – Transfer & NPL, etc). He/she ensures a holistic technical oversight of the activities at the assigned Contract Manufacturing Organizations.The Technical Manager is responsible for establishing a relationship with the MS&T organization of the CMOs and bringing MS&T topics on the agenda of the regular CMO-NVS meetings. The Technical Manager is the technical SPOC for the assigned SRT / CMOs representing ESO/TPO MS&T.Product StewardshipAs Product Steward, the Technical Manager ensures that the products stay in a validated state and their technical performance/capability is monitored. Major accountabilities include: i) assessing impact of manufacturing changes; ii) providing MS&T intelligence to deviations, investigations, OOE’s and OOS’s, technical complaints; iii) defining and tracking technical CAPAs resulting from APR/PQR assessments or manufacturing variances; iv) providing MS&T intelligence to APR/PQR and delivering the performance capability results, interpretations and recommended CAPAs; v) identifying process optimization opportunities and executing them when approved; vi) identifying and leading product manufacturing remediations; vii) establishing and executing product revalidation strategies including approval of QRAs, validation protocols, qualification protocols and reports; viii) establishing and executing continued process verification strategies and annual verification; ix) ensuring maintenance of knowledge for the manufacturing of NVS products ; x) review of QA agreements to ensure that required MS&T deliverables are included.xi) Ensuring that safety and cost aspects are taken into consideration in all activities.Product TransfersAs transfer technical lead, the Technical Manager is responsible for the successful transfer of the manufacturing process (Bulk DP and packaging) and its validation at the receiving site by ensuring subject matter risk assessment and excellence in execution. For complex projects, the Technical Manager can assemble and lead a technical sub-team. He/she supports site selection decisions at the ESO/TPO and/or global boards by providing analysis of technologies and manufacturing risk assessment. He/she will i) support setting the timelines and predecessor/successor activities associated with the change or transfer; ii) establish the technical acceptance criteria and technical go/no-go decision points in collaboration with QA and Reg CMC;iii) Develop Technology Transfer documentation and associated deliverables which may include: updated design documentation, validation plans, specifications, comparability assessments, development plans, other, in accordance with current regulatory requirements and QM; iv) support scope definition and track technical activitiesNew Product LaunchAs the new product launch technical lead, the Technical Manager is responsible for the successful transfers of manufacturing and packaging processes from Development into commercial operations at CMOs. He/she manages the ESO/TPO related technical launch and project improvement activities, leads the respective technical sub team and liaises efficiently with related functions e.g. R&D, Operations, Supply Chain, other sites. He/she ensures appropriate project management to achieve milestones in time, with required quality and in budget.Training & Reference PersonThe Technical Manager trains the ESO/TPO organization on drug manufacturing and packaging science. He/she maintains a level of excellence by proper training and can act as a reference person for given technologies. He/she represents the ESO/TPO MS&T organization in global workstreams (e.g. CPV) and other sister organization (e.g. PharmOps MS&T). When several brands are manufactured at various CMOs and/or internally, the Technical Manager can act as a brand reference person and ensures that product specific learnings made at a CMO are reflected (e.g. verify that CAPAs are consistently deployed across CMOs for a same product).Key Performance Indicators? Technical transfers activities are executed on time and products meet quality requirements? Products and processes at assigned CMOs are in control and capable and maintained in a validated state? Completes remediation activities in accordance with project timelines? Defines and delivers product quality improvements? Ensures key projects such as Launches or API changes are delivered on time, on budget and meet the target success criteria? Recognized as an excellent collaborator and partner by the CMOs, SRTs, QA and others partner functions (R&D)Impact on the organization: Strengthen product/process manufacturing performance, reducing product quality complaints.Improve Supply Chain performance by increasing process robustness, minimizing recalls, rejected batches and write-offs.High; ensures that Novartis products manufactured at CMOs meet stay in a validated state, are trended and optimization potential are implemented.BackgroundEducation : Degree or post-graduation in Science/ PharmacyLanguage: Excellent knowledge of English and proficient in local languageExperience:? 8-10 years of experience in a Pharmaceutical manufacturing/technical environment of Solid, Liquids, Sterile and semi solid Dosage forms? Significant Technical knowhow.? Strong leadership skills with a minimum of 5 years managerial experience preferred.? Demonstrated technical expertise in manufacturing science and drug development of Solid, Liquids, Sterile and semi solid Dosage forms? Significant knowledge of industry practices and regulations (e.g. GxP, ISO, ICH / VICH, etc.) across multiple health authorities (e.g. FDA, EMEA, Health Canada, etc.)Statistical knowledge required, Lean/Six Sigma Certification preferred? Demonstrated leadership and accomplishments in a glob-al/matrix environment in the pharmaceutical industry? Strong project management, interpersonal, cross-cultural, communication, negotiation and problem solving skills 职能类别： 药品生产/质量管理 关键字： Technical manager, technical transfer

联系方式

上海市浦东新区张江高科技园区金科路4218号

公司信息

北京诺华制药有限公司开发、生产和销售治疗多种疾病的创新处方药，涵盖的疾病领域包括：心血管、内分泌、肿瘤、抗感染、风湿疼痛及骨质疏松、移植免疫、中枢神经以及眼科。北京诺华制药曾获得“***雇主”和“最负社会责任的企业”等殊荣。 “诺华”中文取意“承诺中华”，即承诺通过不断创新的产品和服务致力于提高中国人民的健康水平和生活质量。北京诺华制药成立于1987年，总部设在北京，隶属于瑞士诺华公司。 诺华公司致力于为患者及社会提供创新医药保健解决方案，以满足其日益变化的健康需求。2011年，集团持续经营业务实现净销售586亿美元。集团研发投入约为96亿美元（去除减值及摊销后为92亿美元）。诺华集团总部位于瑞士巴塞尔，业务遍及全球140多个国家和地区，拥有124,000位全职员工。诺华集团立足在中国的长期发展，重要战略投资包括位于上海的综合性生物医学研发中心，以及位于北京昌平的制剂生产工厂和江苏常熟的原料药生产工厂。如需更多信息，敬请登录公司网站http://www.novartis.com和http://www.novartis.com.cn。

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