Senior Manager, VER & Micro--USP认证&微生物招聘_美药典标准研发技术服务（上海）有限公司（美国药典）最新招聘信息-猎才医药网

职位描述

职位描述： Summary of the Position:This is a supervisory management position in which the incumbent applies scientific principles and practical laboratory experience to manage the VER & Micro labs and staff of USP-China VER & Micro. Oversees daily operation of the laboratory and interactions with other USP departments and global VER and biological units, leads and manages the China VER & Micro Group to promote good quality products globally.Roles and Responsibilities:?Responsible to ensure that lab adheres to USP’s mission, goals and objectives.?Ensures China VER & Micro meets and complies with the USP guidelines and other requirements.?Performs technical Supervision and training of staff in the lab to build capabilities for core compendial work.?Implements USP Quality Management Systems in VER & Micro.?Reviews data, edits and release reports from VER & Micro.?Responsible for review and implementation of SOPs, protocols, etc.?Directs and implements collaborative project and Verification project works in physicochemical, bioassay and microbial testing relevant to public standards.?Assist in the USP-NF activities for General Chapters, Monographs and Reference Standard development in the area of dietary supplements, antibiotcis or other biologics.?Performs supervisory duties such as performance reviews, objective setting, staff development and career counseling.?Proposes annual budgets, projects resources, capital and personnel needs for the VER & Micro department.?Works with management team to develop and implement strategies and plans to advocate USP biologics standards and verification service in China.?Builds capabilities to conduct classroom and laboratory based PE programs for biologics in China.?Participates in USP cross-functional and global teams as appropriate.?Assists in the development and implementation of safety projects impacting VER & Micro Lab personnel.?Demonstrates a strong desire to continue learning and grow personal capability.?Performs other duties as assigned.Minimum Requirements:Ph.D. in biology or chemistry or related fields with GMP laboratory and industry experience for 8-12 years or Master degree in biology or chemistry or related fields with GMP laboratory and industry experience for12-15 years in the areas of drug product research and development or product release. Chemistry background is preferred. The candidate should have comprehensive experience on analytical methods for the various products such as antibiotics, peptides, proteins, carbohydrates, and other macromolecules in addition to knowledge on quality management system and basic regulatory filing requirements. Hands on people management experience with a group of scientists and good communication skills with multiple disciplines are essential.Knowledge, Skills, Abilities:A comprehensive understanding of the science involved in the development of pharmaceutical standards and reference materials is required. A basic understanding of the processes of the USP is desired. Demonstrates a deep knowledge and strong skills in the areas of physicochemical analysis, bioassay, microbial testing for the biological medicines and dietary supplements. Laboratory experience must include method development and validation - chromatography-based techniques, electrophoresis, colorimetric assays, mass spectrometry, and immunological methods. Experience in the organization and facilitation of collaborative studies is desirable. Excellent technical writing and verbal communication skills in English are required. Good interpersonal skills and proven ability to function in a team-oriented environment are necessary. A proven leadership and staff management skill is a must.Frequent Contacts:Senior Director, Laboratory operations of ChinaSr. Director, VER ProgramOther site VER scientistsOther Site Biology lab directorsGlobal Biologics management teamVER & Micro scientists, USP-ChinaSupervisory Requirements:VER & Micro Scientists 职能类别：生物工程/生物制药

公司信息

关于美国药典委员会美国药典委员会（USP）是一个独立的非营利组织，也是一家具有全球影响力的标准制定机构，在全球范围内开展药品和食品（包括膳食补充剂）的标准制定、认证及培训等相关业务。权威性： USP 成立至今已有近 200 年历史； USP 颁布的药品标准是美国国家法定标准，由美国食品药品管理局（FDA）强制实施， USP 食品成分和膳食补充剂标准是行业普遍使用的推荐标准； USP 专家委员会汇集了包括中国、美国在内的来自监管机构、业界和学术界知名专家；膳食补充剂第三方认证广受美国大型零售商以及药师、营养师的信赖和推荐。全球性： USP 标准和标准品在全球 140 多个国家被广泛使用；在美国、中国、印度、巴西、瑞士、加纳、埃塞俄比亚等国家设有分支机构。关于美国药典委员会中华区总部美国药典委员会中华区总部是美国药典委员会（USP）在中华区设立的全资分支机构。美药典委员会中华区总部于 2006 年在上海张江成立的，随着中国业务的蓬勃发展，2012 年美药典决定增加在华投资，选址外高桥成立“美药典标准研发技术服务（上海）有限公司”。并于 2014 年 1 月起开始正式运营。美药典目前在中国的主要业务分为两部分：承担美国药典总部派发的药典标准和标准品研发任务。涉及的范围包括药品、原料药、辅料、生物制品、膳食补充剂和食品成分等。为中华区使用美国药典的用户提供客户服务、技术培训、认证支持，帮助他们出口产品到美国和其他认可美国药典标准的国家。美药典凭借其在标准研发领域的权威性和技术领先性，先后被列为“技术先进型服务企业”、 “保税监管试点企业”及外商投资“研究开发中心”。美药典拥有 ISO9001 质量体系认证和 ISO17025 实验室认可证书。 2014 年 9 月 18 日国务院总理***在自贸区成立一周年之际视察了美药典，对美药典以标准合作推进中药国际化、促进中国食品医药保健品企业出口所做的努力给予了肯定。 USP中国为您提供实现理想的工作机会，也为您提供与世界各地的科学家、企业合作伙伴、医疗健康机构和政府领袖交流的平台。我们致力于招聘并培养有能力、诚信、充满活力并有热情与我们共同提高全球健康而努力的员工。我们的组织文化, 关注员工授权,职业发展,开放式沟通,和组织的透明度。我们热忱期待您的加入！更多关于USP 的信息，欢迎访问我司网站www.usp.org

周边城市招聘：上海浙江安徽广东山东河北重庆北京江苏湖南

企业入驻日期： 2017-11-09

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