AR&D/QC Manager/ 烟台

月薪： 2.5-3万/月

该公司所有职位
  • 5-7年经验
  • 招若干人
  • 英语熟练
  • 11-16 发布

职位描述

职位描述： Job ObjectivesProvide technical, logistical, and personnel leadership for the Analytical Sciences Group. Function as a leader and technical resource for the business unit and division.Main ResponsibilitiesLab responsibilities?Sets priorities and assigns projects and tasks for the Analytical Development department.?Independently applies scientific knowledge (both theoretical and practical) for the resolution of analytical chemistry problems. Uses outside resources (literature, specialty labs) to address difficult problems.?Introduces new analytical techniques and capabilities to the company. Uses a wide range of analytical and chemical knowledge to solve short and long-term problems.?Provides content, reviews, and writes proposals for analytical development client projects; scientific reports; regulatory documentation and other technical documents.?Reviews data and reports generated by other analysts.?Supervises investigations of difficult technical problems?Interacts with internal and external clients. Responds to regulatory and scientific questions from clients and regulatory agencies?Manages budget for expenses and forecasted revenue. In addition, coordinates capital budget and manages major purchases.?Troubleshoots analyses and instruments.?Supervises the work of scientists and chemists in the Analytical Development department, including working with supervisors for the hiring of staff, performance management and mentoring of staff, and disciplinary actions as required. Also provides technical support to staff.?Manage the sampling, testing and release program for raw materials, in-process samples, bulks and finished products to ensure that all test results are reliable.?Determines technical adequacy of the scientific documents and testing method used within Quality control. Reviews calculations and testing performed within Quality control.?Responsible for bringing new technology and procedures into QC for optimizing compliance and efficiency.?Responsible for method validation, method transfer validation.?Responsible for expeditious testing for resolution of product quality complaints and adverse events complaints.?Responsible for improvement of current QC tests and developing new QC tests with R&D to instigate new QC tests needed for new products.?Provides initial investigation for all quality related complaint and root cause analysis for final investigation.?Makes sure that testing instruments, facilities and test methods used in the laboratories are validated.Quality/Regulatory responsibilities?Manages staff in full compliance with ISO9001 requirements.?Responsible for departmental audit readiness and for participating in quality audits with Regulatory Agencies and customers.?Ensures staff acts in accordance with Johnson Matthey quality policies and practices with respect to ISO9001 and other related requirements.?Implements and applies ISO9001 concepts in association with department specific responsibilities.?Demonstrates technical expertise and self-assuredness in applying ISO9001 standards.EHS responsibilities?Manages staff in full compliance with all appropriate EHS policies and procedures.?Responsible for departmental audit readiness and for participating in audits with internal Company groups, regulatory agencies, and customers.?Ensures staff acts in accordance with EHS policies, practices and procedures. Addresses staff issues accordingly if there are EHS violations.?Actively participates in root cause investigations on near misses and all incidents. Once identified, ensures corrective actions take place and compliance with Company policies and procedures, and all national regulations occurs within the responsible department.?Manages compliance with national and local regulations.?Implements, applies and places emphasis on EHS concepts with department specific responsibilities.?Demonstrated technical and procedural expertise and self-assuredness in applying EH&S policies and procedures.?Support the Company’s commitment for environmental health & safety by applying ISO 9001 and Sustainability 2017 principals into daily activitiesRequirements:?Requires a minimum of a Ph.D. in Analytical Chemistry with 10+ years of experience in organic analysis and chromatography, or a Master’s degree in Analytical or Organic Chemistry with a minimum of 15 years of relevant experience and demonstrated superior technical expertise. Minimum of 5-6 years’ experience with direct process organic product development?Demonstrated laboratory experience with a majority of organic analysis techniques, including HPLC, GC, LC-MS, KF, DSC, TGA, IC, wet chemical analysis.?Experience in a cGMP environment.?In-depth knowledge of the drug development process, especially as it applies to active pharmaceutical ingredients (APIs). Experience managing scientific professionals is required?High proficiency in statistical analysis, use of specialized computer data bases such as LIMS, Stability, and other relevant computer software programs associated with area of responsibility.?High attention to detail, excellent organizational skills and the ability to work on multiple projects with tight deadlines, result orientation and customer focus. 职能类别： 医药技术研发管理人员 生物工程/生物制药 关键字： CRO 实验室管理 分析检测 药品研发 医药中间体 有机合成 诺华制药 康龙华成 睿智化学 保诺制药

联系方式

山东烟台

公司信息

Hopkins & Billion Ltd., is a globally active premier provider for Executive Search & Selection Mandates, Culture Shaping, Leadership Consulting, Executive Coaching, Assessment and Market Intelligence services. Hopkins & Billion focuses especially on a bilateral exchange between the European and Asian markets. Hopkins & Billion has built up a strong partnership and client network within these Geographies. Our Practice Groups are specialized and individually focus on different industries, assignment types, salary scales and locations respectively. By these means we guarantee your hiring requirements will be handled by experts who come with full understanding of your market and industry. For more information about Hopkins & Billion. Please visit www.hopkinsbillion.com

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