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Title Various Positions at Simcere
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Contact info: Dongguowei@simcere.com

先声药业生产系统海外招聘需求20160922
No. 序号 Position 岗位 Job Description 岗位职责概要 Requirements 招聘岗位需求概要 Location 工作地点
1 Vice-President of pharmaceutical business (number:1) 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. 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.  Nanjing
2 General Manager of Quality Assurance (number:1) 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. 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  Nanjing
3 Executive Director of CMO (number:1) 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 . 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.  Nanjing
4 General Manager of pharmaceutical factory (number:1) 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. 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. Hainan
5 Vice-general manager of pharmaceutical factory (number:2) 1.According to the GMP requirments, 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. 1. BS degree in pharmacy or a related field, OR intermdiate 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.  Hainan/ Nanjing
6 Chief Process Engineer of pharmaceutical factory (number:2) 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. 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.  Hainan/ Nanjing
7 FDA On-site Director (number:2) 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. 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.  Hainan/ Nanjing
8 QA Director (number:2) 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; 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.  Hainan/ Nanjing
9 QC Director (number:1) 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; 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.  Hainan/ Nanjing
10 Validation Director (number:2) 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; 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.  Hainan/ Nanjing

 



Title Sr. Project Manager, Commercial Manufacturing (China)
Location Foster City, California, United States
Job Information


Title Various Positions at Kelun (China and US)
Location China and US
Job Information

Please see details in the following links:

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科伦药物研究院招聘职位一览060316

20160304-仿制药-招聘广告



Title Associate Director, Analytical Method Development at Henlius
Job Information

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General Job Accountability

The Associate Director (AMD) is a managerial position responsible of providing leadership to and managing the daily operations of the AMD group. You will be in charge of the analytical method developments, product characterization, and to provide supports for process design/characterization. The position is also responsible to provide analytical supports to company’s regulatory filings, in particular IND and BLA filings.

Job Description

 Lead analytical method developments in monoclonal antibody product development programs;

 Transfer of analytical methods to other functional groups for in-process and/or drug substance (DS)/drug product (DP) release supports;

 Plan and execute necessary characterization of monoclonal antibody to support IND and BLA filings. These include structural and degradation pathway characterizations, as well as resolving stability issues and to support formulation development;

 Evaluate and implement new analytical technologies;

 Collaborate and coordinate with colleagues from basic research, product development, process development, manufacturing, QA and QC teams to increase product quality.。

Job Requirements

Education /Training background:

 MS with 5-10 years’ relevant experience or PhD with 4-8 years’ relevant experience;

 Degree in analytical chemistry, biochemistry, biophysics, pharmaceutical chemistry or related field.

Knowledge/Skills:

 Must have experience in analytical/process development with hands-on and in-depth understanding of different protein characterization techniques and associated instrumentation such as HPLC/UPLC (RPC, SEC, IEX), Capillary Electrophoresis, GC, LS/MS etc. Additional hands-on experience and understanding of protein purification is preferred.

 Good understanding of cGMP, pharmacopeia testing and regulatory requirements for filing and registration of biologics is highly desirable;

 Excellent communication skills: Fluent in Chinese (speaking and writing) and English (reading and writing) to present the company well in internal and external meetings.

 Excellent personal skills to work with diverse team members across various functions, multiple countries at various levels in organization.

 Must be self-motivated and be able to work with minimal supervision in a matrix environment and effectively manage multiple projects.

 Must be capable of multiple-tasking with demonstrated good initiative and judgments.

Please send cover letter and resume to  ekang@henlix.com


Title Director/Associate Director of Manufacturing at Henlius
Location China
Job Information

Job Title:

Director/Associate Director of Manufacturing

Department: Manufacturing Location: Shanghai

Travelling Requirement:Sometimes

Position Summary:

This position is responsible for directing all of biologics manufacturing activities under cGMP in compliance to CFDA, EMEA, US FDA and ICH guidance.

Key Objectives/Principal Accountabilities

• Be responsible for the cGMP operations of biologics manufacturing facilities including upstream cell culture antibody production, downstream protein purification, fill finish and supply chain management.

• Be supportive in biologics cGMP facility development from design, construction, validation to start-up.

• Establishes and optimizes manufacturing policies and cGMP document systems including standard operation procedures and manufacturing batch records.

• Manages strictly the production system and activities according to the US, EU, Chinese GMPs, leads the subordinates and all of manufacturing staff to strictly carry out the related work accordingly.

• Checks the production system, quality system and improve the scheme of technical system and equipment maintenance system.

• Evaluates and controls the cost of production, quality, process and capacity; Develops and controls department budgets.

• Ensures the EHS in manufacturing facilities.

• Prepares the readiness for regulatory inspections on the cGMP facility and biologics manufacturing process.

• Any other ad hoc tasks assigned by line manager.

Requirements for Job:

Competencies and Experience:

• Educated to bachelor, master degree level or equivalent, preferably in related major in biochemical engineering, biotechnology, and biological sciences.

• Minimum 8 years related experiences of manufacturing in a global biopharmaceutical company; and minimum 5 years experiences at managerial level or above.

• Familiar with Biotech industry and monoclonal antibody drug manufacturing.

• Have in-depth knowledge and hands-on experiences with US, EU and Chinese GMPs regulatory and quality standards requirements for biologics manufacturing.

2

•  Understanding of business objectives and the impact of operations and technical activities on those objectives.

• Rich experiences in production management, equipment management, quality management and a regulatory inspection of biologics is highly preferred.

• Excellent verbal and written communication skills in both Chinese and English.

Key behavioural Competencies:

• Excellent organizing ability, communication and interpersonal skills at all levels;

• Strong influencing skills;

• Strong analytical/problem solving skills;

• Ability to lead groups including suborinate, peer, and site leadership。

Please send cover letter and resume to  ekang@henlix.com


Title ANDA Quality Director/ General Manager at Fosun
Location China
Job Information

Job Title: ANDA Quality Director/ General Manager Department: International business Department

(Subsidiary) Business Unit/group: Industrial BU Work Location: Shanghai, China

Job Level: 9/10

Report to: VP, International Business Department Name of VP:

Direct reports (# of FTEs): 0 Indirect reports (#FTEs): 13

Job Purpose/ Key Objective:

* Build Fosun Pharma and subsidiary companies ANDA products quality system with EMA/US FDA standard

* Support Fosun Pharma ANDA products regulatory affairs in regulatory markets

Key Responsibilities

* Support on Fosun Pharma industrial BU quality compliance system with cGMP; and Fosun Pharma industrial BU quality compliance audit system, including policies, procedures and tools

* Working on quality audit for Fosun Pharma strategic & focus products

* Support R&D center and subsidiary companies for al ANDA projects pre-setup, evaluation and regulatory, track all ANDA products quality status with QBD concept and overall control subsidiary companies quality risk, support regulatory in regulated markets

* train subsidiary companies quality and regulatory professionals with FDA criterial and processes

* Play as a senior quality advisor to provide strategic quality insights for Fosun Pharma

Requirements

* Pharmaceutical or Chemical Engineering related master’s degree and above.

* 15+ years QA/QC/RA

* At least 4 years in a leadership position in a US pharmaceutical company

* ANDA product and R&D quality system and knowledge

* Familiar with FDA quality criteria and regulatory processes

* Efficient business acumen with strong project & process management skills

* Good collaboration & communication skill, willing to share knowledge with others

* Provide leadership and management to scientists and research teams

* Proficient with Microsoft Office

* Fluent and literate in English and Chinese

Travel

Frequent domestic business travel is necessary

Please send cover letter and resume to  ekang@henlix.com

 



Title Clinical VP at Henlius
Location China
Job Information

Key Responsibilities:

• Overseeing all ongoing clinical trial program

• Work with the clinical PM to help the development and implementation of clinical trials including planning, protocol design, selection of sites and investigators, conduct of studies, data management and assessment of results

• Is accountable for the conduct of GCP clinical trials in compliance with all relevant regulations and ethical standards

• Ensures compliance of clinical activities with all applicable health, safety, and environmental policies

• Ensures safety of clinical trials, thorough planning, monitoring and evaluation of ongoing study safety reviews, DSMB activities, dose escalation reviews, adverse event reports, etc.

• Manages the preparation of protocols, Investigator Brochures, clinical study reports, safety reports, and the clinical sections of, INDs/IMPDs, NDAs/MAAs, SOPs, investigation plans, abstracts and manuscripts

• Identifies, selects, negotiates and manages activities of CROs, external collaborators, clinical research centers and investigators

• Develops and maintains relationships with regulatory agencies and investigators

• Provides clinical expertise and input to research and development, business development and commercial efforts

• Part of the decision making leadership team.

Requirements:

• Fluent English (both in oral and written) is required

• Advanced degree or equivalent education/degree in life science/healthcare strongly recommended. PhD or MD preferred.

• 10 years technical, operational and managerial experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organization, oversea experience preferred

• Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and global clinical development process.

• Proven ability to work independently, to lead a multidisciplinary trial team in a complex matrix environment (including remote).

• Proven experience in developing effective relationships with key investigators

Please send cover letter and resume to  ekang@henlix.com