Research and Development Manager
碧迪医疗器械(上海)有限公司
- 公司规模:1000-5000人
- 公司性质:外资(欧美)
- 公司行业:医疗设备/器械
职位信息
- 发布日期:2012-08-06
- 工作地点:苏州
- 招聘人数:1
- 职位类别:科研人员
职位描述
Essential functions:
BD Diagnostics Systems is seeking a qualified Manager of Research and Development to lead a Suzhou, China based R&D group engaged in the commercialization of lateral flow immunoassays. Relevant experience includes a proven capacity to effectively lead all stages of assay development from test design, reagent development and qualification, assay optimization including definition of manufacturing processes, development of SOPs and process validation including pilot production of lateral flow devices. The R&D Manager is accountable for maximizing the effective use of resources, development and timely execution of project schedules, ensuring assay development efforts meet all Quality and Design Control requirements, and making certain that safe practices are observed in all laboratory operations. The China-based R&D effort will interface with a BD Point-of-Care R&D organization based in San Diego, California to support prototype assay transfer, final assay optimization, management of field trials and clinical studies, relevant regulatory submission and approval processes, effective transfer to the China-based operations group and post-launch support of assays produced in the China facility.
The R&D Manager will be responsible for providing strong senior level technical leadership for developing new rapid immunoassays to detect infectious disease analytes and facilitating effective collaborative development of rapid immunoassays with San Diego R&D Team. The Manager will work closely with the San Diego-based R&D group and regional business leaders to initiate and direct research and product development programs for the effective introduction of new products, devices and processes consistent with the strategic business plan.
Required Skill Set
? Demonstrated track record of successful product development in developing rapid immunoassay diagnostics/lateral flow products.
? Strong relationship builder, especially cross-culturally.
? Ability to influence through effective communication, people management, and leadership skills are core to this position.
Excellent written and verbal communication skills are essential for this position. The successful candidate will be required to routinely interface with the marketing and sales, business development and manufacturing functions within BD. The candidate must be a proven leader with the ability to direct and manage junior R&D staff members. The development effort will involve a coordinated work plan encompassing contributions from R&D groups across multiple BD business areas and therefore it is essential that the successful candidate have the ability to effectively contribute to cross-site project teams.
Requirements:
This position requires a minimum of 5 years of directly related experience in immunoassay development, particularly in the area of rapid immunoassays, including 2 years in management. Experience in the clinical diagnostics/biotech industry is essential. The successful candidate will have a proven record demonstrating all aspects of product design and development transfer to manufacturing, support of the regulatory and clinical submission process, and commercial launch of in vitro diagnostics assays in China.
Educational Requirements:
MD or PhD degree in Microbiology, Molecular Biology, Biochemistry, Virology, Immunology or other related discipline.
BD Diagnostics Systems is seeking a qualified Manager of Research and Development to lead a Suzhou, China based R&D group engaged in the commercialization of lateral flow immunoassays. Relevant experience includes a proven capacity to effectively lead all stages of assay development from test design, reagent development and qualification, assay optimization including definition of manufacturing processes, development of SOPs and process validation including pilot production of lateral flow devices. The R&D Manager is accountable for maximizing the effective use of resources, development and timely execution of project schedules, ensuring assay development efforts meet all Quality and Design Control requirements, and making certain that safe practices are observed in all laboratory operations. The China-based R&D effort will interface with a BD Point-of-Care R&D organization based in San Diego, California to support prototype assay transfer, final assay optimization, management of field trials and clinical studies, relevant regulatory submission and approval processes, effective transfer to the China-based operations group and post-launch support of assays produced in the China facility.
The R&D Manager will be responsible for providing strong senior level technical leadership for developing new rapid immunoassays to detect infectious disease analytes and facilitating effective collaborative development of rapid immunoassays with San Diego R&D Team. The Manager will work closely with the San Diego-based R&D group and regional business leaders to initiate and direct research and product development programs for the effective introduction of new products, devices and processes consistent with the strategic business plan.
Required Skill Set
? Demonstrated track record of successful product development in developing rapid immunoassay diagnostics/lateral flow products.
? Strong relationship builder, especially cross-culturally.
? Ability to influence through effective communication, people management, and leadership skills are core to this position.
Excellent written and verbal communication skills are essential for this position. The successful candidate will be required to routinely interface with the marketing and sales, business development and manufacturing functions within BD. The candidate must be a proven leader with the ability to direct and manage junior R&D staff members. The development effort will involve a coordinated work plan encompassing contributions from R&D groups across multiple BD business areas and therefore it is essential that the successful candidate have the ability to effectively contribute to cross-site project teams.
Requirements:
This position requires a minimum of 5 years of directly related experience in immunoassay development, particularly in the area of rapid immunoassays, including 2 years in management. Experience in the clinical diagnostics/biotech industry is essential. The successful candidate will have a proven record demonstrating all aspects of product design and development transfer to manufacturing, support of the regulatory and clinical submission process, and commercial launch of in vitro diagnostics assays in China.
Educational Requirements:
MD or PhD degree in Microbiology, Molecular Biology, Biochemistry, Virology, Immunology or other related discipline.
公司介绍
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for healthcare providers. BD and its 65,000 employees have a passion and commitment to help improve patient outcomes, improve the safety and efficiency of clinicians’ care delivery process, enable laboratory scientists to better diagnose disease and advance researchers’ capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. In 2017, BD welcomed C. R. Bard and its products into the BD family. For more information on BD, please visit ******.
关于BD
BD是一家全球化的医疗技术公司,通过改善医学发现方法、医疗诊断效果和护理质量以引领世界健康。BD关注并支持每位一线医务工作者,致力于通过研发创新技术、服务和解决方案,帮助患者改善临床治疗,并帮助医护人员改进临床流程。BD及其65,000名全球员工秉承高度的热情和信念,致力于帮助提升患者的治疗效果,为临床医护人员提供安全、高效的护理给药流程,协助实验室科学家们更有效地诊断疾病,并提升科研人员研发新一代诊断及治疗疾病的能力。BD在几乎所有国家均设有分支机构,与全球范围内的组织机构积极合作,携手应对最具挑战的全球健康问题。通过与客户的紧密协作,BD以改善治疗结果,降低医疗成本,提升诊断效率为己任,帮助加强患者和医护人员的安全并扩大医疗可及性。2017年,BD欢迎巴德及其产品加入BD大家庭。更多信息,敬请访问**********/china。
关于BD
BD是一家全球化的医疗技术公司,通过改善医学发现方法、医疗诊断效果和护理质量以引领世界健康。BD关注并支持每位一线医务工作者,致力于通过研发创新技术、服务和解决方案,帮助患者改善临床治疗,并帮助医护人员改进临床流程。BD及其65,000名全球员工秉承高度的热情和信念,致力于帮助提升患者的治疗效果,为临床医护人员提供安全、高效的护理给药流程,协助实验室科学家们更有效地诊断疾病,并提升科研人员研发新一代诊断及治疗疾病的能力。BD在几乎所有国家均设有分支机构,与全球范围内的组织机构积极合作,携手应对最具挑战的全球健康问题。通过与客户的紧密协作,BD以改善治疗结果,降低医疗成本,提升诊断效率为己任,帮助加强患者和医护人员的安全并扩大医疗可及性。2017年,BD欢迎巴德及其产品加入BD大家庭。更多信息,敬请访问**********/china。
联系方式
- Email:club@51job.com
- 公司地址:中国上海市浦东新区东育路221弄11号前滩世贸中心三期B栋12-18楼 (邮编:200040)