Responsible for extractable &leachable project, working to design protocol, execute experiment plan, interpret data and generate scientific reports, supporting chemistry lab daily maintenance.

1. Extractable & Leachable project

• Design protocol, execute experiment plan, interpret data, and generate scientific reports. Design and conduct analysis on extractable for raw materials and leachable in stability of drug samples and drug products using ICP-MS, UPLC/MS, GC/MS/FID, and various analytical methods.
• Test method development, verification and validation, method translation. Develop proper methods for leachable target in drug products. Unknown peak identification and quantitation.
• Apply existing methods and develop new methods to investigate compatibility between drugs and containers / packaging materials, contributing to regulatory submissions, analytical services for customers and complaints handling.
• Keep close communication with global R&D labs to ensure the test method synchronization.

2. Others

• Laboratory routine instruments maintenance, operation, documentation, safety and sample/reagent management to meet the quality and regulatory compliance.
• Work with other functions such as QA, EHS, Procurement and Supply Chain.

• Work with 3rd party labs for sample analysis when needed

SKILLS AND ABILITIES

• At least Bachelor's degree in Pharmaceutics, Pharmacy, Analytical Chemistry, Chemical Engineering or related discipline with at least 3 years of relevant experience.
• Knowledge and extensive hands-on experience with method development for LC/MS, GC/MS, ICP-MS.
• Must have extensive experience with method validation and transfers for analytical methods according to current regulatory and pharmacopeia guidelines.
• Knowledge of drug packaging materials of glass, rubber and plastics.
• Be familiar with CHP, YBB, GB, USP, EP, ICH etc.
• At least three years of experience in chemical laboratory under ISO17025/GLP/GMP quality system.
• Ability to work independently and experience in a team on multiple projects
• Excellent interpersonal and communication skills
• Excellent communication (oral and written) and interpersonal skills in order to interface with global R&D groups, global manufacturing plants and regulatory teams.

Be careful and conscientious; be initiative, independent, good communication and team collaboration.

上班地址：工业园区白榆路5号

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 bd.com.

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www.bd.com/china。