10 years pharmaceutical experience in the development of APIs from upscaling of synthetic routes to pilot/commercial scale; process transfer as well as project management and new product development team management; Extensive hands on experience in API process development, scale up and commercial process validation, technology transfer and contract manufacturing and cost evaluation/calculation of APIs Expertise includes knowledge of ICH & FDA guidelines, current Good Manufacturing Practices (cGMP) for API. Expertise on evaluating API process and determining the process patents/IP status; and design/optimize API process without any IP issue; Good Expertise on team management of chemistry synthesis in CRO and new API development in pharmaceutical companies. Strong background in organic synthesis chemistry and medicinal chemistry;
美国凯默斯医药公司上海办事处
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高级经理美国凯默斯医药公司上海办事处 May 2010 - Present中国 上海Responsible new products development department management, including:1. Manage new products development team for contributions to API process development process from labscale to commercial production with sufficient documentary supports to pass US FDA inspection;2. Sourcing qualified API manufacturers (if no manufacturer, looking for a contract lab/Institute to develop aprocess and then transfer the process to a suitable factory to produce);3. Evaluate and calculate the cost of APIs, with the help of the headquarters, finalize the price;4. Evaluate API processes and confirm the process doesn’t infringe any active patents and with no IP issue;5. Guide factories to solve quality, impurity and scale- up problems and set specifications for APIs as well asoptimize process to reduce cost;6. Draft and review blank production batch record and process validation protocol of an API that is coming toconduct process validation to confirm the documents meet FDA cGMP requirements;7. Prepare technical package and DMF documents with the regulatory department;8. Manage the API projects and confirm the factory can deliver the qualified API on time and meet the plannedproject timeline.9. Responsibilities included developing new purification method or optimizing the old purification method toremove or reduce impurities within impurities limit and improve API quality.
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Project LeaderSundia Meditech Company May 2008 - May 2010上海市Responsible for managing 4 FTE (full time employee) project teams (> 20 FTE), including:Work Experiences1. Manage FTE project teams to achieve project milestones/timeline and customers’ requirements;2. Participate in a medicinal chemistry project, and lead a team to complete a serial of bioactive compounds synthesis base on modification of Berberine.3. Lead a team to synthesize a serial of bioactive compounds based on modification of Vancomycin, and lead compounds have obtained, and this project has moved to an advanced stage from chemistry stage.4. Manage a FTE project about target compounds synthesis. Complete dozens of target compounds synthesis which was provided from clients.5. Manage a FTE project about medicinal chemistry. Design and synthesize a serial of medicinal compounds base on SAR (structure and activity relationship).In my first two FTE projects, my responsibilities are designing synthesis route, exploring practical synthesis method, improve compound quality, and training low level chemists. And in my second two FTE projects, my responsibilities are managing the team to make whole projects running well and smoothly to achieve client’s target, as well as designing synthesis route, solving organic synthesis /quality issues on daily work.II. Responsible for quote base projects, including:1. Synthesized a medicinal compound possessing potential bioactivity through 7 steps reaction, which contain a critical photosensitized reaction.2. Prepared an 11 peptide compound through 10 steps reaction. Because of excellent performance in this tough compound preparation, positive feedback was obtained from clients, and high praise from CEO in staff meeting.3. Completed several building block compounds in up to 50g scale.
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Post DoctorUniversity Of Nebrska Medical Center Mar 2006 - May 2008Omaha, Ne, Usa
金红霞 Education Details
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上海有机化学研究所优秀 -
西北大学Top 3 In Whole Department
Frequently Asked Questions about 金红霞
What company does 金红霞 work for?
金红霞 works for 美国凯默斯医药公司上海办事处
What is 金红霞's role at the current company?
金红霞's current role is 美国凯默斯医药公司上海办事处 - 高级经理.
What schools did 金红霞 attend?
金红霞 attended 上海有机化学研究所, 西北大学.
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