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SABPA Newsletter, October 2016
In This Issue
Upcoming Events
 
The 2nd SABPA/UCSD career development forum (Oct. 18th)
The 6th SABPA/ACS Chemistry Symposium
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SABPA Events

The 2nd SABPA/UCSD career development forum

 

When: 6:00-8:30pm, Tuesday, October 18, 2016
Where: Sanford Consortium @UCSD (Rm 1013A/B) 2880 Torrey Pines Scenic Drive, San Diego
Title: The First Step: How to step into the door of biotech industry
While academic research positions in academia remain a popular choice, many postdocs are interested in exploring careers in the biotech and pharmaceutical industry. However, many find it challenging to map out the first steps for getting their first industry job. In the 2nd Career Development Forum co-organized by SABPA and the UCSD Postdoc Association, we have invited Mr. Jon Mason II, Director of Talent and Organizational Performance Solutions (TOPS) at Pfizer, to share his experience from an industry insider’s perspective with postdocs and early career scientists. We have also invited four panelists from the local biotech/pharmaceutical industry to share their stories with you in an informative and interactive forum.
Panelists:
Jon Mason II, Director of Talent and Organizational Performance Solutions (TOPS), Pfizer
Erika Anderson, Ph.D., Microbiome Research Scientist, Human Longevity, Inc.
Valentina Molteni, Ph.D., Director of Medicinal Chemistry, Genomics Institute of the Novartis Research Foundation
Chris Rhodes, PhD., CEO, Drug Delivery Experts
Marianna Zipeto, Ph.D., Study Director, Crown Bioscience
Schedule:
6:00 – 6:30 PM        Registration and Networking
6:30 – 7:00 PM  Presentation
7:00 – 8:00 PM Panel Discussion
8:00 – 8:30 PM        Networking & Wrap Up

The 6th SABPA/ACS Chemistry Symposium

 

 
When: 5:00 PM – 7:30 PM, Thursday, October 27, 2016
Where: Knobbe Martens Olson & Bear LLP, 12790 El Camino Real, San Diego, CA 92130
Speakers:
 
David W. C. MacMillan, PhD, James S. McDonnell Distinguished University Professor of Chemistry, Department of Chemistry, Princeton University
Pierre-Yves Michellys, Director of Medicinal chemistry, Genomics Institute of the Novartis Research Foundation

SABPA Annoucements

A tale of two SABPA committees becoming one
The Establishment of a New Combined SABPA Event: Frontiers in Therapeutics and Diagnostics (FTD) Forum
Over the years, SABPA members have been attracted to many of our annual events.  One of those is the Science & Technology Forum which has been one of the oldest and most successful scientific events of SABPA.  Years later, with the recent boom of the diagnostic industry in San Diego, our Medical Device & Diagnostics Forum has become a rising star among all of the events organized by SABPA. To carry on the tradition and to continue with the momentum of these two events that are both innovation-driven and science-focusing, the SABPA leadership team has decided to combine them into one big event with pooling resources. Now it is the time to present to you our newly formed committee responsible for organizing this exciting new annual forum named “Frontiers in Therapeutics & Diagnostics”.
The mission of the Frontiers in Therapeutics and Diagnostics (FTD) committee is to support the development of therapeutics and diagnostic tests that will enhance human health and improve patient care. The FTD forum will bridge the research communities involved in therapeutics, diagnostics and related fields. It will bring together experts of drug R&D and Medical Device and Diagnostics fields to share ideas and expertise and to highlight recent breakthroughs and industry trends. It will be a one-day event with plenary lectures, presentations, and panel discussion. Both established experts and newcomers to the field will benefit and enjoy the multi-disciplinary science and technology in an engaging and exciting venue.
Together with our annual Biopharma Conference and Pacific Forum, Frontiers in Therapeutics & Diagnostics Forum will become one of the three pillars of SABPA flagship annual events that we can all look forward to year after year.
Frontier in Therapeutics and Diagnostics Committee will be led by:
Hua Gong, Chair Guang Cheng, Co-Chair  Hui Wang, Co-Chair Howard Pan, Co-Chair
Yahu Liu, President, SABPA, San Diego Chapter
Stephanie Shi, EVP, SABPA, San Diego Chapter

SABPA leadership update
We would like to take this opportunity to update with the changes in the leadership team of the SABPA San Diego Chapter.
The Science & Technology Committee and Medical Device & Diagnostics Committee were dissolved, since we have decided to combine Science & Technology Forum and Medical Device & Diagnostics Forum into them into Frontiers in Therapeutics& Diagnostics forum. We thank Marie Zhang, Guang Chen, Hui Wang, Xing Yang, Caroline Cheung, Hua Gong, Lei Zhang, Howard Pan, Shuangwei Li, Susan Wang, Jiali Li, and Runquan Zhang as well as many others for their contributions during the past years.
The following Chairs and Co-Chairs had to leave their positons due to other commitments, job/location change or persnal reasons. We would like to express our thanks to them for their contributions to SABPA’s success.
Commitee
Position
Name
Affiliation
Chemistry
Co-Chair
Jacqui Hoffman
Pfizer
Communication and Publication
Co-Chair
Linxuan Yan
Scripps
Entrepreneur
Chair
Tianlun Wang
ACRO Consulting
Pacific Alliance
Co-Chair
Xiaolin Li
GIMDx, Inc
Photography
Co-Chair
Hao Jiang
GB Lifesciences
Sponsor Relations
Co-Chair
Shanshan Yan
GNF, Novartis
Treasurers
Co-Chair
Wei Tan
Pfizer
Webmasters
Co-Chair
Heng Dai
Wuxi Apptec
We are pleased to announce the following new chairs and co-chairs and we thank them for taking responsibilities when their leadership is needed by SABPA.
Commitee
Position
Name
Affiliation
Chemistry
Co-Chair
Wei Wang
Pfizer
Education and Career Development
Co-Chair
Hua Deng
Davidia
Entrepreneur
Chair
Jay Jiang
UCSD
Pacific Alliance
Co-Chair
Shuangwei Li
Wellspring Biosciences
Membership
Co-Chair
Jian Liu
Nitto Bio Sciences
Photography
Co-Chair
Shuangding Wu
Qool Labs
Social Event
Co-Chair
Kevin Xin
Scripps
Sponsor Relations
Co-Chair
Howard Pan
NanoString
Webmasters
Co-Chair
Ying Ding
Pfizer
Yahu Liu, President, SABPA, San Diego Chapter
Stephanie Shi, EVP, SABPA, San Diego Chapter

 

 
PS.
SABPA SD Chapter Leadership (updated on September 20, 2016)

SABPA Reports

12th SABPA Pacific Forum
On October 1, SABPA hosted its 12th annual Pacific Forum at the Hilton Del Mar, San Diego. California congressman Scott Peters gave the opening remark for the forum. Mr. Peters stressed that San Diego is one of the top Biopharma hub in the United States, ranks second in terms of the number of scientists and ranks third in biotech investment. Mr. Peters have always supported the development of local biotech and pharmaceutical companies and he believes the success of this industry will have great impact on the development of San Diego. In addition, Mr. Peters gave SABPA a special award for its contribution in advancing the San Diego Biopharma industry.
Congressman Scott Peters presented SABPA an award for its contribution to the biotech and pharmaceutical community
Dr. Gregory Frost, managing director of F1 BioVentures highlighting the rapid growth of the Chinese Biopharma industry. One example he showed is that although the total number of early clinical research projects for cancer in China is ¼ of those in the United States, in the field of CAR-T therapy, China has 51 clinical studies while US only has 37. This comparison suggests that China has the capability to pass US by focusing on cutting edge therapies.
The second presentation was delivered by Dr. Mao Mao, the CSO of BGI Genomics. Dr. Mao showed that hereditary newborn diseases are a heavy medical burden for the society, and it is especially severe for certain population. For example, in the Jewish community in Eastern and Central Europe, people have a much higher chance to carry mutations that cause the Tay-Sachs disease. Genetic screening is a great tool to help identify hereditary diseases in newborns and Dr. Mao introduced BGI’s efforts in using new technologies such as next-generation sequencing for genetic screening in China.
After a short break, Dr. Henry Ji, CEO of Sorrento Therapeutics, gave an excellent talk introducing his company. Although the Sorrento’s stock has underperformed in the last 12 months, Dr. Ji is not worried. He thinks Sorrento will be a huge success in the future and he gave out multiple reasons: The technology of Sorrento Therapeutics can make drugs targeting intracellular targets, which is rare and valuable; Sorrento has multiple pipelines, which gives the company flexibility in its business model. It can pursue drug development or out licensing; In addition, the company’s “Discovery and Development” model is also very unique. His talk received big applause from the audience.
The morning panel discussion is focused on cancer immune therapy. Lead by Dr. Karsten Sauer, director of Cancer Immunology from Pfizer, panelists including Dr. Ji, Dr. Alan Paau from Advanced Immune Medical Systems, Dr. Jayant Thatte from Crown Biosciences San Diego, Dr. Stephen Schoenberger from La Jolla Institute for Allergy & Immunology and Dr. Michael Seiler from Taconic Biosciences shared with the audience their opinion on multiple challenges related to cancer immune therapy. For example, on how to choose mouse models for cancer immune therapy, the experts cautioned that there are major difference in the genetic background between mouse models and human. Deep understanding of the science is always the key to pick the right model for your study. The difference in microbiome will have a huge impact on the immune response.
The afternoon session started with the presentation of the 2016 Pacific Life Science Achievement Award. Dr. Lieming Ding from Betta Pharmaceuticals received this honor. In his acceptance speech, Dr. Ding discussed the lessons learned through the development of Icotinib, the first innovative small molecule drug entirely developed in China to treat non-small cell lung cancer. It annual sale totals 1 billion RMB and has surpassed competition from major international drug companies. Dr. Ding noted that targeting the right disease with innovative drug is key to its success because lung cancer is the number 1 cancer in China with huge medical need. In addition, being innovative is also the key to receive tremendous governmental support. It only takes 8 years for Betta to develop the Icotinib, which is very fast in the drug development field. Professional and collaborative team members, sound management and great partnership with doctors, government, media and banks all contribute to the speedy development process.
Dr. Lieming Ding, recipient of the 2016 Pacific Life Science Achievement Award
Dr. Jin Li from HitGen followed with a speech named “Finding Needles in Very Large Haystacks: DNA-Encoded Libraries (DELs) for Lead Generation.” He introduced the DELs technology, which can dramatically cut down the cost of finding lead molecules for drug discovery. The DELs allow the scientists to make compound libraries with great structural variety and each different structure is labeled by a unique combination of oligoDNA “code”. Screening can be conducted by applying the library in a pool format and use next generation sequencing to identify small molecules that bind to the target. HitGen has had great success identifying small molecules that bind various targets.
Tony Chen from Jones Day Law Firm gave the speech titled “Promoting Biotech Industry in China with Strong Intellectual Property Protection”. In his speech, Mr. Chen compared the patent policy difference between the United States and China and its effect on investment for innovative R&D. Although China has great innovative potential with its enormous market, abundant capital and rich talent pool, it has lagged behind United States and Korea in terms of producing pharmaceutical Intellectual property. Mr. Chen believes part of the reason is that the patent policy is more geared towards increasing accessibility of new drug. However, he provided evidence showing that by improving IP protection, it can not only encourage innovative research, but also improve accessibility of new drugs at the same time. He encourage the audience to facilitate China’s improvement on IP protection by influencing the policy makers in amending the patent law, patent examination guideline, drug administration law and drug registration regulation.
Dr. David Brenner, dean of the UCSD school of medicine, outlined UCSD’s effort in conducting drug discovery in the university setting. Dr. Brenner suggested that the multidisciplinary assets in UCSD could be organized to perform roles in different steps of drug discovery. For example, the chemistry department and the engineering departments can provide expertise that is necessary for rational and computational drug design. He also gave several examples of drug development based on UCSD assets including drugs to treat parasite diseases and drugs based on natural products in the ocean through collaboration with the Scripps Institute of Oceanography.
Deans of Pharmacological Sciences from Chongqing University, Fudan University, Peking University and Xiamen University participated in the afternoon panel discussion moderated by Dr. David Brenner. They discussed various topics including how to facilitate international student enrollment in China and how to promote translational research in the university setting. Fudan University is located in the “Pharma Valley” in Shanghai. Therefore, it has a policy to encourage undergraduate students to get training in biotech companies as part of its educational program. Deans in the panel also fielded questions from the audience and had a lively and entertaining discussion with the audience on questions such as how to transfer and value intellectual property.
Dean’s Forum
In the end, Dr. Stephanie Shi, the executive vice president of SABPA thanked all the speakers, sponsors and volunteers for their contribution in making the 12th Pacific Forum another huge success. This year, the Pacific Forum also hosted the first every science poster competition. It not only attracted postdocs and graduate students from local institutions such as Salk, Scripps, UCSD and Calibr, but also students from Zhejiang University of Technology. It is a great venue for young scientists to interact with professionals in the biotech and pharmaceutical industry.

2016 Biobeach Summer Program graduation ceremony

 

On August 26, 2016, UCSD, SABPA and Davidia Healthtech co-organized 2016 BioBeach Summer Program graduation ceremony.
40 undergraduate students from Zhejiang University of Technology enrolled in the 2016 BioBeach Summer Program, a 4-week program designed by SABPA together with UCSD Extension, Collaborative Innovation Center of Yangtze River Delta Region Green Pharmaceuticals, School of Pharmacy from Zhejiang University of Technology (ZJUT) and Davidia Healthtech. During the four weeks, the students took Drug Development course (2 units) and Medicinal Chemistry course (3 units) tailored by UCSD extension, which were taught by Dr. Yves Theriault (President of The California Institute for Performance Management) and Professor Dionicio Siegel (Associate Professor at the Skaggs School of Pharmacy and Pharmaceutical Sciences, UCSD).
SABPA organized students’ visits to Dart NeuroScience, Janssen R&D LLC of JNJ, Pfizer, Salk Institute, The Scripps Research Institute, Sanford Consortium for Regenerative Medicine, UCSD Skaggs School of Pharmacy and Pharmaceutical Sciences, and UCLA. The students also participated in volunteering work at the San Diego Food Bank and SABPA annual picnic. SABPA also provided 9 lectures which were taught by experienced experts in biotech and pharmaceutical industry to discuss cutting-edge technologies. We thank the following SABPA lecturers for their excellent teaching.
Dr. Weijun Shen, Principal Investigator, California Institute for Biomedical Research
Dr. Alan Paau, Former Vice Chancellor of Conell University
Dr. Zhizhong Li, Research Investigaor, Genomics Institute of the Novartis Research Foundation
Dr. Yang Liu, Director, Center for Stem Cell and Regenerative Medicine, Sanford Burnham Medical Research Institute
Dr. Wei Wang, Professor, Department of Chemistry and Biochemistry, Department of Cellular and Molecular Medicine, UCSD
Dr. Hua Gong, MD, Sr. Director, Clinical Trial Testing Group, Genoptix, a Novartis Company
Dr. Hovik Gukasyan, Drug Product Design Research & Development, Pfizer
Dr. John Gu, Founder, President, and Chief Scientific Officer, Renascions
Dr. Peter Huang, Former Lead Designer of Pfizer.
The 2016 BioBeach program is a great success. One of SABPA’s missions is to stimulate and nurture innovative ideas and entrepreneurship, and to bring public awareness of the benefits of biomedical research. SABPA is looking forward to organizing the BioBeach Summer Program in collaboration with the same partners continually in the coming years.

Report about 2016 BioBeach Program
East-West Connections: UC San Diego Extension helps forge new alliances across the Pacific
written by Jennifer White

 

Bridging academics with industry is one of UC San Diego Extension’s hallmarks and its recent BioBeach Summer program was no exception. Through the unique program, 40 students from Zhejiang University of Technology were able to study at a world-renowned research institution while getting a firsthand look at San Diego’s ever-growing biomedical and pharmaceutical industry.
To develop the program, UC San Diego Extension partnered Sino-American Biotechnology and Pharmaceutical Professional Association (SABPA) and Davidia Healthtech, a San Diego-based biomedical technology company. Both SABPA and Davidia worked with Extension because they knew Extension had the expertise to design a program that met Zhejiang University of Technology’s stringent scientific requirements as well as provide connections to a myriad of biomedical and pharmaceutical companies.
The visiting Zhejiang University of Technology students participated in a highly tailored program that offered classes in such disciplines as medicinal chemistry and drug development, taught by UC San Diego professors including Dr. Dionicio Siegel, associate professor, UC San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences. In addition, UC San Diego Extension instructors and experts from the pharmaceutical industry lectured students on trending topics and scientific breakthroughs. To reinforce the classroom learning, the Zhejiang University students visited biotech and pharmaceutical companies including Pfizer, Johnson & Johnson and Dart NueroScience.
Hua Deng, Ph.D., president of Davidia Healthtech and a former UC San Diego Extension student, said the program was able to link knowledge with practice in a unique way.
“UC San Diego Extension is able to connect an academic background with industry experience because the instructors are leading scientists and researchers themselves,” she said.
Dr. Yahu A. Liu, president of SABPA and an investigator at Genomics institute of the Novartis Research Foundation, said BioBeach also provided a window into one the most successful biotech clusters in the world.
“The students got to know the biotech industry, which is very famous here in San Diego. It expands the student’s vision and understanding of the industry,” he said.
Emphasis was not only placed on academics, the group also took a number of cultural fieldtrips to some of San Diego’s most famous attractions. They also spent an afternoon doing community service at SABPA’s annual picnic where they had the occasion to practice their conversational English.
Despite all the cultural and academic opportunities, the students agreed that the real highlight was San Diego’s preeminent attraction – the beach.
Because the BioBeach program was such a success – both for students and for the program partners – there are plans to continue and expand the program to offer more Zhejiang University of Technology students the opportunity to study the growing biotech sector with a San Diego perspective.
Reflecting on her first abroad experience, Yiwen Wu, one of the Zhejiang students, said the BioBeach program changed both the way she viewed learning and her educational goals.
“This experience impressed me a lot,” she said. “It taught me that I can go on to get a master’s and a doctor’s degree. What impressed me most was people’s attitude about studying here.”

Job Postings
Simcere Pharmaceutical Group (先声药业)
 
Please contact Guowei Dong at dongguowei@simcere.com if you are interested in any of the following positions.

 

1. Vice-President of pharmaceutical business (Location: Nanjing)
Job Description:
1、Manage the entire pharmaceutical business of Simcere, include manufacturing technology, engineering facilities,EHS, lean manufacturing, GMP certification implementation, pharmaceutical internationalization management.
2、According to the annual strategic target and manufacturing target, organize and carry out the annual manufacturing plan
3、Participate in the management of all manufactures, manage the human resource, materials, and energy which are demanded by production, technology, and engineering facilities of Simcere.
4、Responsible for the audit and guidance of  manufactures’ equipment procurement and workshop rebuilding,
5、Control and reduce the manufacturing cost, ensure the quality and safety, reach the manufacturing output target.
6、Attract commissioned processing business.

Job Requirements:

1、MS degree in pharmacy,  chemistry or a related field, work experience with oversea companies a plus
2、15+years pharmaceutical industry working experience in famous local  company or oversea company and company with foreign capital. 10+ years management experience of manufacturing, familiar with manufacturing management, engineering design, cost control, quality management, warehouse and logistics management.
3、Familiar with the entire operational and technological process of manufacture, especially in manufacturing control and  field management.
4、Familiar with certification of quality system and the lean production(LP) mode, expert in every step of manufacturing;
5、Must have high level of professional morality level, detail-oriented, highly the sense of responsibility and efficiency, teamwork and cooperation.
6、Excellent oral, written and presentation skills in both English and Chinese.
2. General Manager of Quality Assurance (Location: Nanjing)
Job Description:
1、Design and implement the quality assurance strategy, plan, system, and related institution.
2、Directly manage the quality assurance work, responsible for the quality assurance management and guidance of subordinate companies and domestic and foreign companies.
3、According to the annual manufacturing target , make the quality assurance management strategy of Simcere; Audit the quality control policy, procedure, institution and operation standards, rout and track the implement of quality assurance policy.
4、Establish the preparations and APIs quality assurance system, ensure the quality assurance system in Simcere satisfying the requirements of domestic and foreign GMP certification.
5、Excutive the veto of quality, orgnize the important special project conference, coordinate the work of every department.
6、Supervise and contral the domestic and foreign  examination of preparation and APIs in Simcere.
Job Requirements:
1、BS degree in  pharmacy or a related field, work experience with oversea companies a plus. 10+years quality assurance management working experience(APIs, preparations(solid preparations and freeze-dried powder injection))
2、Familier with the current situation and prospect of pharmaceutical industry, have interpersonal connections in the industry.
3、Must have rich experience in foreign preparations and APIs registration and GMP certification.
4、Excellence in cooperation and communication
5、Have the ability to deal with the emegency situation
3. Executive Director of CMO (Location: Nanjing)
Job Description:
1. Initiate and develop cooperation relationships with national and international resources.
2. Evaluate the dominant resources such like equipment, capacity, and technicality,    identify and track the CMO cooperation opportunities and models .
3. Draft and track the CMO development schedule, evaluate the CMO result and solve the problems in the project process.
4. Effectively negotiate the project agreement, and carry out the production plan. Maintain the orderly operation of  CMO order process.
5. Directly manage the CMO project, including the technology transfer, production management evaluation, cost and benefit management and etc..
6. Directly manage the team, coordinate effective proposal management with the inner groups, maintain the cooperation relationship with the customers and the CMO project proceed smoothly .
Job Requirements:
1. MS degree in pharmaceutical engineering, pharmacy, biology, chemistry or a related field,oversea working experience is a plus.
2. 8+ years of drug manufacture industry working experience, at least 3+ years of CMO working experience, possess  knowledge of CMO, business development, and drug manufactory.
3. Have extensive international pharmaceutical industry resources and pharmaceutical business development experience, familiarity with the national and international pharmaceutical industry and the requirement of GMP/CGMP. Possess strong negotiation skills and rich experience in the contract negotiation.
4. Excellent oral, written and presentation skills in both English and Chinese.
4. General Manager of Pharmaceutical Factory (Location: Hainan)
Job Description:
1、Manage the routine work of the factory, responsible for all of the manufacturing management and the production quality. Adopt the board resolution,and  implement the company’s strategy, development plan, and operating target  according to the strategic target and operating decision suggested by the board or group, .
2、Organize the basic team building, standardize internal management,  establish the internal  organization structure, and management system, make the operationg strategy.
3、To take charge of the review and approval of rewards and punishment rules, payment, performance management system and bonus project.
4、Improve construction of corporation culture, deal with the emergencies of the company.
5、Supervise the implementation of the EHS management.
Job Requirements:
1、MS degree in pharmacy or a related field, work experience with oversea companies a plus.
2、10+years of business management experience, understand the core of  advanced business management.
3、Have strategic vision and sharp sense, familiar with the development tend of pharmaceutical industry, manufacturing management and quality management. Familiar with GMP and CGMP.
4、Excellent oral, written and presentation skills in both English and Chinese.
5. Vice-General Manager of Pharmaceutical Factory (2 available, location: Hainan/Nanjing)
Job Description:
1.According to the GMP requirements, help the general manager manage the routine work of the factory, reach the management and development targets.
2.Estabulish the system of directing manufacture, make and track the manufacture plan, ensure the completion of production task.
3. According to the manufacture plan, track the producation progress and coordinate with the workshops to balance the labor, equipments  and materials.
4.Organize the production analysis conference, analyze the production situation and suggest the problem-solving method.
5. According to the peoduction demands, make and implement the material purchasing plan, solve the material shortage in time.
6. Resposible for the technology and quality assurance management during manufacture. Find and solve  the problem, report to the general manager if there is something emergency.
7. Improve the EHS working , organize the safety and environment inspection regularly, implement the EHS management policy and supervise the problem-solving procedure.
Job Requirements:
1. BS degree in pharmacy or a related field, OR intermediate professional certification or above,work experience with oversea companies a plus
2. More than10 years of drug manufacture and quality management experience, at least 3 years management experience. have professional production related training experience.
3. Familiar with GMP and CGMP.
4. have strong sense of responsibility and adaptation, be good at organization, cooperation, communication, leading and sharp sense. strong logical thinking ability, good execution, judgment. being able to work under presure.
5. Honest and reliable.
6. Chief Process Engineer of Pharmaceutical Factory (2 openings, location: Hainan/Nanjing)
Job Description:
1. According to the GMP requirements, responsible for the technical study and improvement. Audit and guide the production technical process and technical standards files.
2. Responsible for the R&D of new production and the improvement of the old production. In charge of the implementation of the R&D technology, oragnize and implement the new drug R&D project establishment, plan, experiment, submittal. Write and review the new drug application document. Develop the new drug which meets the market demands.
Job Requirements:
1. BS degree in pharmacy or related  field, Pharmaceutic preparation is a plus.
2.15+years drug production working experience in preparation company, familiar with the technoloies of all kinds of preparation, and the realistic use of new preparation technologies. Have rich experience in preparation technology transformation and pilot-plant-scale.
3.Familar with the theory and performance of the preparation production equipment, have successful experience of preparation prodution problem-solving, especially in preparation technology transformation and pilot-plant-scale.
4.Familar with GMP requirements of drug register, and the principle of ICH production reseach, quality evaluation  in Europe and America.
5.Be good at organization, cooperation, communication,problem-solving and team-leading.
7. FDA On-site Director (2 openings, location: Hainan/Nanjing)
Job Description:
1. Familiar with laws and regulations such as FDA, and EUGMP, and proficient in related guidelines of international certification.
2. Establishing quality management system accord with US FDA and EUGMP, and auditing quality management documents about FDA.
3. Responsible for FDA certification and test work, and drawing up plans and reports for self-inspection, and following up implementation of rectification of inappropriateness.
4. Responsible for instructions for production, verification and change control of export drugs, giving suggestions in time as well.
5. Carrying out training on FDA or EU regulations for instructions for production, verification, and auditing schemes and reports.
6. Responsible for programs of US FDA certification for application materials, and reply for on-site inspection.
Job Requirements:
1.MS degree or above, majored in medicine、pharmaceutical analysis or related, and with senior professional titles or above.
2. Engaged in pharmaceutical production / technology / quality work, or other work experience in chemistry laboratory analysis, and proficient in GMP.FDA application experience is preferred.
8. QA Director (2 openings, location : Hainan/Nanjing)
Job Description:
1. Responsible for establishment、operation、 maintenance and improvement of GMP quality management system, and timely supervision,、inspection、 guidance for GMP implementation;
2. Responsible for the release of materials and products, and QA supervision and inspection of links in a chain of production;Responsible for regular reviews of quality of products;
3. Responsible for management of GMP file system;
4. Responsible for dealing with internal-external audits and certifications, as well as tracking inspection of rectification work, to ensure audits smoothly;Responsible for audits and file maintenance of suppliers;
5. Working for organizations for verification and validation, change management, deviation handling, risk assessment, CAPA and other works;
6. Responsible for maintenance of department regulations related to environment, occupational health and safety;
Job Requirements:
1. MS  degree or above, majored in pharmacy or related;
2. More than 10 years of experience in QA management;
3. Excellent in English listening and speaking;
4. Familiar with GMP specifications ,and regulations and laws of various countries;
5. Responsibilities, good communication and coordination, and skilled in analysis and problem-solving, and with teamwork spirit.
9. QC Director (location: Hainan/Nanjing)
Job Description:
1. Responsible for management and construction in laboratory for making quality system  effectively run;
2. Responsible for completion of raw materials, intermediates, inside and outside package materials, finished products (including the stability of samples) ,as well as high quality and low cost;
3. Working in with inspection of new projects, and providing technical supports for validations of process ,cleaning and registration of new products;
4. Responsible for verification and validation and maintenance of analytical instrumentations, and for computer system and audit trails to meet the GMP requirements;
5. Responsible for stabilities of program management and monitoring;
6. Responsible for implementations of internal audit and GMP monitoring;Ready to meet audits at home and abroad smoothly;
7. Taking in charge of laboratory deviations, OOS/OOT laboratory investigations, quality risk assessment, and CAPA trails;
8. Responsible for instructions for SOP, program and report validation, GMP document development and improvement;
Job Requirements:
1. MS  degree or above, major in pharmaceutical analysis or pharmacy;
2. More than 10 years of experience in QC management;
3. Excellent in English listening and speaking;
4. Familiar with pharmaceutical GMP standards, National Pharmacopoeia requirements, and testing procedures of various countries;
5. Responsibilities, good communication and coordination, and skilled in analysis and problem-solving, and with teamwork spirit.
10. Validation Director (2 openings, location: Hainan/Nanjing)

Job Description:

1. Responsible for development of  master plan and annual validation plan, and implementation of verification work;
2. Responsible for management processes of validation, and SOP related;
3. Responsible for audits of URS, validation program and report;
4. Leading implementation of validation activities for a state of verification of plant facilities, utilities and equipment; responsible for implementation of validation of analysis method, transportation, cleaning and process;
5. Responsible for deviation and change, and allows for verify internal deviation from the perspective of validation;
6. Responsible for formation, maintenance and management of validation team, following up implementation of program within group;
7. Checking daily operation of tracking inspection for project implementation in accordance with the plan, and deviation investigation with rectification report;
Job Requirements:
1. MS  degree or above, majored in pharmacy or related;
2. More than 10 years of experience in QA management;
3. Excellent in English listening and speaking;
4. Familiar with GMP specifications ,and regulations and laws of various countries;
5. Responsibilities, good communication and coordination, and skilled in analysis and problem-solving, and with teamwork spirit.
In addition, Simcere (先声药业集团) and Bioscikin (精准医疗百家汇) have multiple trainee program openings, please see here for detailed description. 

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About SABPA
Sino-American Biotechnology and Pharmaceutical Professionals Association (SABPA) is an 501(c)(3) nonprofit organization founded in early 2002 by professionals and scholars from the Chinese community in San Diego. In 2005, we expanded to Orange County and Los Angeles. We invite all scholars, professionals and entrepreneurs of any origin who are working in, engaged in, or interested in the biotech and pharmaceutical industry in Southern California to join us as a member of SABPA.
Our Mission
  • Provide a forum to facilitate professional contact and communication among local Chinese American professionals in academia, biotech and pharmaceutical industries;
  • Foster professional growth, career improvement and personal development of our members;
  • Provide opportunities to educate local communities about the values of biomedical research and the benefits of biotech and pharmaceutical innovations;
  • Stimulate and facilitate the development of relationships between the U.S. and China in biotech and pharmaceutical communities.
  • To fulfill our mission, we will sponsor professional seminars, meetings, and symposia; share employment opportunity information in local biotech and pharmaceutical industry; sponsor social events; and disseminate information about local biotech and pharmaceutical companies.
SABPA.org, P.O. BOX 927631, San Diego, CA 92192
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