【药物质量分析高级科学家招聘】_猎头顾问招聘信息-猎聘

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资深顾问 · 上海德筑企业管理有限公司

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职位介绍: 这位科学家将负责领导分析开发、方法验证、稳定性研究和方法转移，以开发满足患者各种剂型患者需求的新药产品。该职位将与多团队合作，执行开发，提交和技术转让工作流程，重点是与全球垂直研发团队，监管，临床，技术服务，生产基地和中国第三方合作 Main Accountabilities/Responsibilities (Including but not limited to): 1. Product Development – Launches, Analytical Development, Validation, Stability, Submissions · Independently develops and validates a variety of advanced analytical methods. Proactively and independently apply best practices to work assignments. · Following general guidance and leads methods transfer for new products from Global R&D to Dalian or CMO. ·Provides analytical support in the scale-up and manufacture of demonstration/registration/validation /clinical batches. · Performs data collection and analysis, discusses conclusions regarding progress of work, and effectively communicates information to supervisor in the form of discussions and reports. · Authors and reviews stability protocols/reports, method transfer protocols/reports, and other technical documents. Authors and reviews documents for regulatory submissions. · Establishes and monitors developmental stability programs to assess viability of dosage forms. · Routinely demonstrates a good practice of technical exchange and open communication with global team members. · Interacts constructively with cross functions developing key partnership and actively sharing knowledge. 2. Problem Solving · Independently develops, recommends, and implements a new technology, process or system that can solve moderately complex problems. 3. Innovation · Frequently develops and introduces new processes/ideas and or technologies that add value. · Proposes solutions to increase workgroup effectiveness. 4. Compliance · Assures awareness and compliance with current and developing regulations with Boards of Health (i.e., NMPA, FDA etc.), other regulatory agencies and with corporate policies. · Performs job responsibilities in compliance with EHS, cGMP, GLP and all other regulatory agency requirements, where applicable. Minimum Experience / Training Required: 1. Minimum Working Experiences · MS degree with a minimum of 3 years of relevant experience · Ph.D. degree with a minimum of 0-1 years of relevant experience · Area of Specialization: Major in Pharmaceutical Analysis, Pharmaceutics, Chemistry Analysis, or related fields. 2. Technical competencies · Successful track record of analytical development, method transfer, submissions, with good understanding of drug product development process. · Dosage form expertise desired includes different Oral Solid Dosages, experience on other dosage forms like oral solutions, Injections, etc. are favorable. · Demonstrated strong expertise in leading project teams engaged in analytical development, stability study, method transfer and commercialization. · Good understanding of NMPA regulatory requirements and CDE/ICH technical guidelines. 3. Other Job-Related skills · Good oral and written English skills. · Good communication & influencing skills. · Proven demonstration to take initiative, think and work independently, problem-solving, work effectively in teams, and multitask

其他信息: 语言要求：普通话 + 英语; 行业要求：制药,生物技术,医药流通

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