• Lead assay development on both biochemical and cell based assays, compound screening, and other in vitro experiments.
• Communicate with clients, generate study proposals, and analyze data.
• Manage a group of scientists and the associated laboratory and equipment.
• Work with other teams in collaboration.

Actual level and compensation will be based on work experience.

Requirements:

• D in biochemistry or related biological science fields with more than three years of experience in assays development.
• Good oral and written communication skills in both Chinese and English.
• Function well in a team environment.
• Overseas study/work experience is a plus.

Location: Shanghai, China

• Lead a team of 6-8 scientists on execution of pathology projects, in support of pharmacology and toxicology studies
• Manage daily operation of the pathology lab
• Work collaboratively with clients, design experimental approaches, draft study proposal and quotation, score and analyze data, and prepare study report
• Lead team to plan and conduct the experiments, including but is not limited to, tissue processing, embedding, sectioning, H&E staining, special staining, IHC, IF, FISH, RNA-ISH; Troubleshoot and provide ongoing technical guidance to team members as needed
• Maintain close and effective communication with clients, report study progress in a timely manner, through emails or teleconferences

Requirements:

• D. or M.S. in Pathology, Biology, or Life Sciences with 5+ years relevant pathology experience; Industrial experience is not required, but will be considered as a major plus;
• Solid knowledge and understanding on pathology; familiar with pharmacology models and toxicology studies;
• Must be proficient on pathology-related technical skills, and be able to provide technical guidance as needed;
• Strong organization, communication and interpersonal skills to be able to effectively interact within clients, team members and other functional groups, must be capable of multitasking
• Self-starter with high energy level, creative problem solver, eager to learn new technology and skills
• Must be proficient on both written and oral English 

Location: Shanghai, China

• Lead therapeutic antibody discovery programs including reviewing project targets, design study plan with clients and ChemParter project leaders, draft or edit project proposals and reports.
• Provide scientific advice and leadership to ChemPartner project teams and input to clients in driving the project to successfully achieve specific objectives and milestones.
• Act in a project management capacity for multiple on-going projects and provide solutions and action items for any issues that occur during project execution. Act as the primary point of contact for clients and facilitate liaison with the scientific team in Shanghai.
• Provide scientific input to the broad biologics team by providing ideas for innovations and new scientific approaches/techniques that can be adopted.
• Be jointly accountable (along with other biologics leaders) to the company management team for the success of the department  and to communicate scientific and technology advances in biologics discovery
• Closely work with existing ChemPartner BD team to maintain and enhance customer relationships as well as aid in building new relationships. Visit with existing and new clients with a view to raising awareness of ChemPartner biologics capability

Requirements:

• Ph.D. /MD with 10+ years or MS/BS with 15+ years industry experiences in therapeutic antibody discovery, with expertise in immunology, molecular biology, biochemistry, biotechnology or biological sciences.
• Highly motivated scientific leader with a proven track record in antibody lead generation, antibody engineering, preferably with bioassay development capabilities and experiences. .
• Strong communication skills, both oral and written, in English. Ability of communication in Chinese would be advantageous although not imperative.
•  Experienced in managing a scientific team including PhD scientists and multiple therapeutic programs.
• The incumbent will be required to focus on multiple issues at one time, and must have the ability to organize and direct diverse activities in a changing environment, often under time pressure.
• With a mature, self-confident and well-balanced personality, it is essential that the candidate also possess a high standard of ethical and intellectual integrity.

Location: Shanghai, China

1. Leading a group of scientists and be responsible for recombinant protein production including construct design, expression and purification in E.coli, insect cell or mammalian systems.
2. Managing the group and taking responsibility for its projects by driving and coordinating his/her direct reports in achieving the specific objectives of protein generation projects.
3. Taking responsibility for defining project requirements, identifying potential issues, and providing solutions to resolve the issues.
4. Managing resources rationally and ensuing effective completion of multiple studies.

Requirements:

1. Ph.D. in protein chemistry, biology, biochemistry, structural biology or related fields.Highly motivated scientific leader with a proven track record in;
2. Protein Science. Overseas work education and experience will be a plus;
3. A thorough understanding and hand-on experience in molecular biology, protein expression, purification and characterization in E.coli or insect cell system or mammalian systems;
4. Strong communication skills, both oral and written, in Chinese and English. Experienced in managing a scientific team including PhD scientists.

Location: Shanghai, China

Key Accountabilities.：

1. To coordinate the entire process of pharmacokinetics (PK) studies from initiation of the study to the report writing for quality and timely delivery
2. To communicate with clients about technical details, project update and timeline

Scope of the Job：

1. To design PK/PKPD/Tox studies, write study proposals, protocols, in-life summaries and study reports;
2. To analyze, trouble shoot and interpret the PK data;
3. To communicate internally with multiple groups, e.g. formulation, bianalytical, in-life, non-GLP tox etc. for study arrangement;
4. To track project status, make sure all the studies completed on time;
5. To communicate with client for any issues occurred during project process. Work with the client to come up with solutions;
6. To work closely with Chemistry, Biology department, especially for integrate service project. Provide weekly PK update to the project team.

Skills and Education.：

1. Ph.D. degree in biochemistry, biology, pharmacology or other related fields; Master degree with 3-4 years related work experiences;
2. Knowledge or hand-on animal handling experience is preferred;
3. Knowledge of basic principles of pharmacokinetics and data analysis;
4. Familiar with and able to comply with IACUC, SOP, EHS regulations is a plus;
5. Able to work well in a team;
6. Good written and reading skills in English;
7. Previous working experiences in CRO or pharmaceutical company are preferred.

Location: Shanghai ,China

Primary Responsibilities:

1. Manage a team to design, develop, and validate various bioanalytical
2. methods, majority of which are LC-MS based.
3. Manage a team to analyze biological samples derived from pre-clinical or clinical studies; analytes range from drug molecules to biomarkers
4. Lead the team to provide scientific supervision and training
5. Oversee client’s projects and manage projects
6. Maintain close and effective communication with clients, report studies progress in a timely manner
7. Participate in client visit, represent the department

Requirement:

1. PhD with more than 10 years of relevant industrial experience
2. Knowledge of mass spectrometry bio-analysis is essential
3. Hands-on and supervisory experience in assay development, validation, and sample analysis
4. Must be able to work in a dynamic working environment and able to multi-tasking
5. Good communication and interpersonal skill

Locaiton: Shanghai,China

1. To propose safety and preclinical strategies, design and coordinate appropriate  non-GLP and GLP Tox to support preclinical development of drug candidates successfully IND filing
2. To implement tox studies in preparing protocols, monitoring study progress, analyzing data and writing reports and regulatory documentation and filing
3. To coordinate cross-functional effort (Discovery, Pharmacology, PKPD, BioAnalytical, CMC and business partners) in planning budgets, timelines and resource allocations
4. To participate meeting and teleconference with global clients/team members during after work hours
5. To communicate with regulatory agencies in defending preclinical packages
6. Might supervise and team build team, depending upon qualification, a group of SDs

Requirement

1. A MD, MS or Ph.D in biochemistry, biology, DMPK preferably tox
2. In-depth knowledge of preclinical toxicology (in vitro and in vivo), SOP, guidelines and GLP principles is must
3. Well understanding of FDA, cFDA and EMA regulations and registrations required
4. Prior experience in preclinical development in life science industry highly desired
5. Hands on experience in animal study and/or biology assay, Pharmacokinetics, Metabolisms, and Bioanalytical assay highly expected
6. Excellent interpersonal and communication in both Chinese and English
7. Strong collaborative skills and ability to work in a team environment expected

Location: Shanghai,China

1. Lead a team of scientists and associates to screen and develop stable cell lines for therapeutic protein expression in the industrial setting.
2. Design, execute and supervise cell screening and stable cell line development   Excellent troubleshooting skill is needed.
3. Hold regular communication with clients in written and oral formats.
4. Write and review technical reports and regulatory submission files.
5. Ability to manage multiple projects in parallel with different priorities
6. Day-to-day team operation management.

Requirement:

1. D. degree in cell biology, biochemistry, molecular biology, biochemical engineering or other related fields is required.
2. A minimum of 8 years of working experience in biotherapeutic development environment with good track record in cell screening and stable cell line development is required. Experiences in international pharmaceutical companies are preferred.
3. Excellent knowledge in molecular biology, cell biology and mammalian cell development are required.
4. Has leadership vision, with good management and team building skills. Fluent communication in both English and Chinese.
5. Experience in regulatory submission is a plus.

Location: Shanghai, China

1. Lead a team of scientists and associates to develop the processes of cell fermentation from small scale to production scale for therapeutic protein in laboratory, pilot and production setting.
2. Develop and customize the cell culture for fermentation if needed.
3. Design, execute and supervise fermentation development programs. Excellent
   troubleshooting skill is needed.
4. Hold regular communication with clients in written and oral formats.
5. Write and review technical reports and regulatory submission files.
6. Ability to manage multiple projects in parallel with different priorities
7. Day-to-day team operation management.

Requirement:

1. D. degree in cell biology, biochemistry, molecular biology, biochemical engineering or other related fields is required.
2. A minimum of 8 years of working experience in biopharmaceutical development environment with good track record in fermentation process development is required. Experiences in international pharmaceutical companies are preferred.
3. Extensive experiences on CHO stable cell line development, up-stream process development, antibody drug production at small and pilot scale, including but not limited to major aspect of unit operations in seed expansion, fed-batch process development at bench-top and pilot single-use bioreactors, etc.
4. Highly experienced in assessing, communicating and streamlining technology and process transfer between development and manufacturing.  Process development or manufacture experience with commercial biopharmaceutical products is a big plus.
5. Has leadership vision, with good management and team building skills. Fluent communication in both English and Chinese.
6. Experience in regulatory submission is a plus.

Location: Shanghai, China

1. Lead a team of scientists and associates to develop purification and viral inactivation processes from small scale to production scale for therapeutic protein drug substance in laboratory, pilot and production setting.
2. Assure pathogen safety during the entire drug substance manufacturing processes.
3. Design, execute and supervise purification development programs. Excellent troubleshooting skill is needed.
   Hold regular communication with clients in written and oral formats.
4. Write and review technical reports and regulatory submission files.
5. Ability to manage multiple projects in parallel with different priorities
6. Day-to-day team operation management.

Requirement:

1. D. degree in biochemistry, molecular biology, bioengineering, or other related fields is required.
2. A minimum of 8 years of working experience in biopharmaceutical development environment with good track record in purification process development for therapeutic protein is required. Experiences in international pharmaceutical companies are preferred.
3. Extensive experiences on down-stream process development, antibody drug production at small and pilot scale, especially for mammalian cells. 
4. Highly experienced in assessing, communicating and streamlining technology and process transfer between development and manufacturing. 
5. Has leadership vision, with good management and team building skills. Fluent communication in both English and Chinese. 
6. Experience in regulatory submission is a plus.

Location:Shanghai,China

1. Provide direction and tactical leadership to the Quality Assurance of Biologics Development and Manufacturing.
2. Define, implement, and manage the various quality programs needed to ensure compliance of Good Manufacturing Practices and Good Laboratory Practices.
3. Ensure that the Quality functions are adequately staffed and organized to support biologics development and manufacturing activities.
4. Lead the Validation function, including process and computer systems validation.
5. Lead all Quality operations (e.g. product disposition, deviation investigations, etc.).
6. Maintain facility compliance and inspection readiness for Biologics.
7. Ensure timely reporting of deviations, issues, etc. to executive management as required.
8. Identify and implement Quality improvement activities related to compliance, cost and cycle time.
9. Strategize and collaborate with other functional groups to ensure timely completion of all objectives and milestones, including Manufacturing, Supply Chain, Product Development, and Regulatory Affairs, Quality control etc.
10. Drive risk analysis and develops solutions to a variety of complex problems.
11. Support, direct, and coach subordinate employees.

Requirement:

1. D. degree in life science related fields and a minimum of 8 years of working experience in biopharmaceutical development environment, with at least three years of progressive experience in quality assurance or quality control, preferably in biologics. Experiences in international pharmaceutical companies are preferred.
2. The ideal candidate will have following attributes or knowledge:
3. Perform at QA Head level-through knowledge of GMP practices and international equivalents.
4. Demonstrate leadership and teambuilding.
5. Resolve conflict and manage changes.
6. Possess skills in analytical problem solving, negotiation, project management, coaching, mentoring and counseling.
7. Demonstrate skills developing and implementing practices and procedures which minimize product quality and compliance issues.
8. Skills in principle and applications of validation processes.
9. Excellent communication skills.
10. Bilingual preferred: English and Chinese, verbal & written.
11. Knowledge of aseptic biological drug substance and drug product manufacturing techniques.
12. Domestic (SFDA) and/or international regulatory inspection experience.

Location: Shanghai, China

Major responsibilities :

1. Lead a group of analytical development scientists & QC analysts for conducting assigned projects & tasks in the areas described above to meet company, project goals, expectations in a tight time line;
2. Lead the group for the development, transfer, validation and execution of various bioassays for supporting various process development and GMP manufacturing activities for therapeutic antibody and protein drugs
3. Review, Draft, and approve SOPs related to the areas of bioassay group functions;
4. Validate, manage, and maintain relevant analytical instruments in good and sustainable operational conditions;
5. Manage internal and external projects, testing tasks, contracts effectively and efficiently
6. Interact and collaborate with internal groups, departments, as well as external clients, customers effectively;
7. Write, review and approve technical documents, validation and other QC related documents, and make presentations for internal company use as well as for external clients, customers;
8. Lead the group for effective deviation, OOS investigation in a timely manner;
9. Manage group member performance effectively
10. Prepare technical registration documents for regulatory submission.

Requirements:

1. PD in Biology, Bio-analytical or other relevant fields with at least 5-10 years of relevant experience;
2. Proficiency in various biological & bio-analytical assay technologies, e.g., Cell-based assays including but not limited to ADCC/CDC, and Cellular Proliferation assays, ELISA, FACS, Mammalian cell culture, etc.
3. Indepth understanding, knowledge, and experience in bioassay development, validation
4. Demonstrated capability of developing various Bio-assays independently
5. Demonstrated capability of leading & managing a group of bio-analytical scientists for the execution of multiple projects in a fast-pace environment
6. Solid GMP knowledge, experience, adequate knowledge of Quality Control operation
7. Good oral and written communication skills in English and Chinese;
8. Be able to work effectively in a team oriented and fast pace

Location: Shanghai, China

Major responsibilities:

1. Lead a group of analytical development scientists & QC analysts for conducting assigned projects & tasks in the areas described above to meet company, project goals, expectations in a tight time line;
2. Lead the group for the development, transfer, validation and execution of various immunological, analytical methods for supporting cell line development, as well as upstream and downstream process development and GMP manufacturing activities for therapeutic antibody and protein drugs, products for clients, customers
3. Review, Draft, and approve SOPs related to the areas of analytical group functions;
4. Validate, manage, and maintain relevant analytical instruments in good and sustainable operational conditions
5. Manage internal and external projects, testing tasks, contracts effectively and efficiently
6. Interact and collaborate with internal groups, departments, as well as external clients, customers effectively
7. Write, review and approve technical documents, validation and other QC related documents, and make presentations for internal company use as well as for external clients, customers;
8. Lead the group for effective deviation, OOS investigation in a timely manner;
9. Manage group member performance effectively
10. Prepare technical registration documents for regulatory submission.

Requirements:

1. PD in biochemistry, immunology or other relevant fields with at least 5-10 years of relevant experience;
2. Has indepth experience and working knowledge in the use of multiple biochemical and immunological technologies, methodologies for the analysis of protein, antibody, antibody conjugates, and peptide products, and complex protein samples; methods include but not limited to ELISA based binding assay, Host cell protein (HCP) assay, host cell DNA assay, residual protein A assay, plus other impurity assays using immunological detection tools like antibodies, one dimensional and two dimensional gel electrophoresis techniques with western blot.
3. Indepth understanding, knowledge, and experience in analytical method development, validation for therapeutic protein, antibody, and antibody conjugate, peptide products
4. Demonstrated capability of developing various analytical methods independently for therapeutic protein, antibody, antibody conjugate, petide products
5. Demonstrated capability of leading & managing a group of analytical scientists for the execution of multiple projects, testing activities in a fast-pace environment
6. Solid GMP knowledge, experience, adequate knowledge of Quality Control operation
7. Good oral and written communication skills in English and Chinese
8. Be able to work effectively in a team oriented and fast pace

Location: Shanghai ,China

The Manager & Associate Director & Director of the protein analytical chemistry group has the responsibility of leading a group of analytical development scientists & quality control analysts for the development, improvement, and execution of a variety of biochemical and analytical methods for the analysis of proteins, antibodies, peptides, as well as chemicals, excipients., etc,  in their concentration, size, identity, purity, impurity, product heterogeneity, conformation, structure, and other relevant chemical, biochemical, and biophysical characteristics.  Besides leading the group to support various process development activities he/she will also have the responsibilities for transferring, validating and implementing a variety of analytical methods for supporting GMP manufacturing, QC testing of therapeutic antibody, and protein products for various clients, customers.

Major responsibilities:

1. Lead a group of analytical development scientists & QC analysts for conducting assigned projects & tasks in the areas described above to meet company, project goals, expectations in a tight time line;
2. Lead the group for the development, transfer, validation and execution of various analytical methods for supporting cell line development, as well as upstream and downstream process development and GMP manufacturing activities for therapeutic antibody and protein drugs, products for clients, customers
3. Review, Draft, and approve SOPs related to the areas of analytical group functions;
4. Validate, manage, and maintain relevant analytical instruments in good and sustainable operational conditions
5. Manage internal and external projects, testing tasks, contracts effectively and efficiently
6. Interact and collaborate with internal groups, departments, as well as external clients, customers effectively
7. Write, review and approve technical documents, validation and other QC related documents, and make presentations for internal company use as well as for external clients, customers;
8. Lead the group for effective deviation, OOS investigation in a timely manner;
9. Manage group member performance effectively
10. Prepare technical registration documents for regulatory submission.

Requirements:

1. PD in biochemistry, analytical or other relevant fields with at least 5-10 years of relevant experience;
2. Has indepth experience and working knowledge in use of multiple analytical technologies, including but not limited to UV/VIS, HPLC/UPLC, Capillary electrophoresis (CE), DSC, DLS, CD, FTIR for the analysis of proteins, antibodies, peptides, chemicals, excipients.
3. Indepth understanding, knowledge, and experience in analytical method development, validation for therapeutic protein, antibody products
4. Demonstrated capability of developing various analytical methods independently for therapeutic protein, antibody products
5. Demonstrated capability of leading & managing a group of analytical scientists for the execution of multiple projects, testing activities in a fast-pace environment
6. Solid GMP knowledge, experience, adequate knowledge of Quality Control operation
7. Good oral and written communication skills in English and Chinese
8. Be able to work effectively in a team oriented and fast pace

Location: Shanghai, China

1. Upgrade existing document control system to improve compliance and work flow
2. Evaluate and conceptualize changes to improve effectiveness and reduce inefficiency
3. Ensure documentation system is in line with existing business needs
4. Ensure operating documentation meet project and customer requirements
5. Train, mentor and develop quality staff to improve facility’s Good Documentation Practice
6. Align core documentation practices of various business groups

Qualification

1. BS in life science or related field
2. 10+ years experience in regulated industry, 4 of which in document control area
3. Familiar with GMP operational principles and practices
4. Works independently, self-motivated, and results oriented
5. Ability to work across lines of authority
6. Above average command of English in reading and comprehension

Location:  Shanghai ,China

1. Responsible for quality systems setup, maintenance and improvement
2. Lead department effort in change control, deviation, CAPA,
3. Define, implement raw material qualification and receiving/inspection programs
4. Define, implement in-process QA oversight
5. Define, implement product release process
6. Lead and direct deviation management as QA representative
7. Lead and direct OOS investigation and closure from QA perspective
8. Manage change control to meet requirements of internal and customer requirements
9. Manage CAPA system to ensure continued monitoring and progress
10. Participate in other quality systems maintenance, improvement and management as required

Qualification:

1. BS/MS/PhD in life science or related field
2. 7+ years experience in drug/biologics quality assurance
3. Clear understanding of pharma quality assurance principles and practices
4. Excellent personal skills, with ability to lead and influence by example
5. Works independently, self-motivated, and results oriented
6. Ability to read and write in English at technical and operational levels

1. Take up project administration role in quality operations
2. Take up project administration role in customer project operations
3. Analyse, organize and deliver Project needs for QA activities to QA members
4. Generate, maintain and track project plans using MS Project or equivalent
5. Identify and update Project objectives, milestones, timelines, resources and constrains
6. Serve as interface between QA and Project team members to ensure proper input and output are updated in timely manner
7. Initiate QA departmental project planning. Track and maintain QA project status

Qualification：

1. BS/MS in life science
2. 7 + years experience in pharmaceutical/biotechnology industries
3. 2+ years experience in the role of project management
4. Must possess ability to initiate and maintain project plans using MS Project or equivalent
5. Excellent personal skills, with ability to influence others
6. Works independently, self-motivated, and results oriented
7. Exceptional verbal delivery and writing skills
8. Above average in English, must be at technical, operational and business levels

Location: Shanghai, China

主要职责：   

1. 领导该组分析人员进行与蛋白质大分子药物相关的各项生物物理，质谱等表征分析工作，以支持生物大分子药物开发；
2. 领导该组分析人员承接客户外包项目，进行蛋白质，抗体等生物大分子样品，产品的各种表征分析工作，满足客户的需求；
3. 有效地管理该组各种测试任务，分析项目和外包合同；
4. 有效的安排管理组内分析人员的工作和仪器使用，以达到最高的工作效率；
5. 在良好和可持续的运营条件下验证，管理和维护该组相关分析仪器，以满足与生物大分子药物相关的申报要求及客户的样品，产品检测要求；
6. 与内部团队、部门以及外部客户有效地进行互动和协作；
7. 有效地管理团队成员的绩效；
8. 为管理部门提交技术登记文件。

要求: 

1. 博士（Ph.D），生物化学，生物物理，在蛋白质化学，生物物理、质谱分析或其它相关领域至少有10年以上的相关工作经验；
2. 有深入的蛋白质大分子生物物理，蛋白质化学及质谱的工作经验及知识，有生物大分子药物的申报经验 （SDA， FDA）；
3. 熟悉并掌握以下重要生物大分子分析表征技术，包括但不限Biacore、DSC、CD， FTIR，LC-MS；
4. 具有领导和管理分析团队的能力，能够执行多个项目，在快速环境下进行测试活动；
5. 具有非常良好的中，英文表达能力， 包括口头和书面沟通能力；
6. 能在团队合作和快速的环境下有效地工作。

工作地点: 上海

涵盖多个领域，包括毒理学、生物分析科学、PKPD和专题负责人的毒理团队的核心主管，并与项目研究涉及的其他职能部门合作和协调。

1. 制定和实施非临床安全策略，设计毒理学研究，撰写监管法规文件；
2. 作为项目团队的主管，与内部和外部合作伙伴以及监管机构进行互动；
3. 确保高标准开展和报告非临床安全性和调查性毒理学研究，并指导和管理专题负责人团队，应用和诠释毒理学评估;
4. 监督和管理CRO的研究,以确保安评研究的高质量交付;
5. 配合管理层管理部门预算和资源。
6. 确保研究机构的运行管理符合药物非临床研究质量管理规范的要求

任职资格：

1. 生物学、毒理学或相关领域博士和/或兽医(DVM)、医学博士(MD)；
2. 具有毒理学和/或病理学协会认证证书最佳；
3. 具有10年以上的新型治疗药物的临床前安全性评估经验；
4. 具有关GLP合规以及相关的ICH和CFDA指导文件相关知识和经验；
5. 具有与临床前部门如QA、生物分析科学、法规事务、等部门协作的经验；
6. 出色的人际交往能力和沟通技巧；
7. 结果导向，解决问题能力强。
8. 学历 : 博士研究生及以上

工作地点：江苏启东

1. 全面负责病理实验室的组织管理工作；
2. 确保病理研究人员熟练掌握相关SOP,组织制订、更新和完善毒性病理实验室相关的标准操作规程（SOP）；
3. 负责督促病理仪器设备的保管、检查、维护等工作，确保仪器状态符合试验需要，确保实验人员对仪器设备的正确使用，并严格遵循相关SOP；
4. 制定病理研究年度工作计划，并及时向专题负责人或机构负责人汇报工作进展及工作中出现的问题；
5. 接受质量保证部门（QAU）的检查，及时处理QAU提出的问题，确保研究任务按时保质完成；
6. 对病理所涉及到的各个试验操作环节进行质量控制（QC），确保试验的顺利进行；
7. 按GLP及试验方案的要求，完成毒性病理学的评价，完成大体和组织病理学的观察和病理报告的撰写等；
8. 负责对病理技术人员进行岗前培训、专业技术培训和考核，制定对病理技术人员的年度培训计划，确保技术人员的业务素质不断提升；
9. 负责本单位除安全性评价研究工作以外的其他组织病理阅片诊断工作；
10. 负责或监督建立本单位动物试验毒性病理的背景数据。

任职资质：

1. 病理学、医学或相关专业硕士或以上学历，中级或以上职称；
2. 3年或以上的动物组织阅片诊断经验，参加过病理学专业的培训。熟悉整个病理检查工作的流程，能够鉴别制片过程中常见人工因素导致的切片异常和真正病理学的形态改变。具有一定的动物自发病变的背景知识，对实验动物的正常生理变化有正确的认识；
3. 熟悉《药物非临床研究质量管理规范》，能制订与本工作岗位相关的标准操作规程（SOP）；了解药物安全性评价的知识，熟悉整个药物安全性评价的过程。有3年或以上的GLP工作经验优先考虑；
4. 具备良好语言和书面的沟通能力和协调能力；
5. 团队协作；
6. 英语听说读写流利。

工作地点: 江苏启东

1. 保存正在实施中的研究的试验方案及试验方案修改的副本、现行标准操作规程的副本，并及时获得主计划表的副本；
2. 审查试验方案是否符合本规范的要求，审查工作应当记录归档；
3. 根据研究的内容和持续时间制定检查计划，对每项研究实施检查，以确认所有研究均按照本规范的要求进行，并记录检查的内容、发现的问题、提出的建议等；
4. 定期检查研究机构的运行管理状况，以确认研究机构的工作按照本规范的要求进行；
5. 对检查中发现的任何问题、提出的建议应当跟踪检查并核实整改结果；
6. 以书面形式及时向机构负责人或者专题负责人报告检查结果，对于多场所研究，分研究场所的质量保证人员需将检查结果报告给其研究机构内的主要研究者和机构负责人，以及主研究场所的机构负责人、专题负责人和质量保证人员；
7. 审查总结报告，签署质量保证声明，明确陈述检查的内容和检查时间，以及检查结果报告给机构负责人、专题负责人、主要研究者（多场所研究情况下）的日期，以确认其准确完整地描述了研究的方法、程序、结果，真实全面地反映研究的原始数据；
8. 审核研究机构内所有现行标准操作规程，参与标准操作规程的制定和修改。

任职资格：

1. 临床医学、药学或相关专业硕士或以上学历人员。
2. 具备作为质量负责人完成药物毒性试验的工作经验和工作能力，参加过相关毒性专业或质量负责人等的相关培训。
3. 有3年或以上的GLP工作经验，熟悉《药物非临床研究质量管理规范》。能制订与本工作岗位相关的标准操作规程（SOP）。了解药物安全性评价的知识，熟悉整个药物安全性评价的过程。
4. 具备良好语言和书面的沟通能力和协调能力；
5. 团队协作；
6. 英语听说读写流利。

工作地点: 江苏启东

1. 独立熟练地操作相应的分析仪器（HPLC、GC、LCMS、KF etc.）完成相应样品的分析。
2. 保证化合物分析方法确认/转移工作的展开符合FDA cGMP，ICH指导原则和内部质量体系的要求。
3. 完成项目IPC分析方法的确认，包括分析条件与方法专属性的确认。
4. 与Process R&D方法研发人员保持沟通联系，及时解决方法存在的问题。
5. 密切关注并解决产品分析过程中出现的问题，为工厂合成人员或工程师提供分析技术支持，独立或在他人指导下解决实验过程中的疑难问题。
6. 做好实验记录，确保行为举止符合公司IP，安全，卫生等规范。
7. 领导布置的其他任务。

岗位要求：

1. 本科或以上学历，药物分析或分析化学专业。
2. 2年或以上相关工作经验，熟悉药厂GMP相关规定。
3. 良好的个人品质和团队合作精神。
4. 具有钻研精神，良好的表达能力与协调能力。

工作地点: 上海奉贤

1. 能独立完成药物分析各项试验。
2. 能独立完成原料药及制剂质量分析方法开发和验证（HPLC,GC,溶出等)。
3. 化合物结构确证的测试及解析。
4. 原料药及制剂样品的放行，制定质量标准，稳定性研究。
5. 对药品注册法规有一定了解，并在一定指导下起草部分申报资料。
6. 领导安排的其他工作。

岗位要求：

1. 本科及以上学历，药学、药物分析、化学相关专业。
2. 本科三年以上，硕士一年以上药物分析或化学分析经验。
3. 对中国药典及药品注册法规有一定了解。
4. 熟悉各种分析仪器及分析方法。
5. 有上进心，较强的工作责任心，良好的沟通能力，优秀的团队合作精神。

工作地点: 上海张江

1. 熟悉常规剂型及制剂设备的使用及维护，有一定的固体制剂、注射剂或外用制剂研发经验；
2. 对新药和仿制药的研发及申报有一定了解；
3. 对常规剂型的分析及质量标准有一定了解；
4. 负责制剂产品的研发、处方工艺设计、优化，以及相关申报资料的撰写工作。
5. 领导布置的其他按工作。

岗位要求:

1. 本科或以上学历，药剂学、中药学、制药工程、食品科学、物理化学、应用化学等相关专业；
2. 英语CET-4级以上，男女不限；
3. 能独立承担制剂研发工作内容，有效总结与沟通，具有良好的团队合作能力；
4. 1-10年工作经验，有缓控释制剂、软胶囊、注射剂、外用制剂相关经验者优先。

工作地点: 上海张江

1. 根据药物合成要求和规范确定起始物料及合成路线，制定原料及产品的质量标准；
2. 根据项目不同阶段，按照商业化生产对质量和成本的要求，制定小试实验方案，中试实验方案及工艺验证方案；
3. 按照公司安全及GMP质量控制规范，负责工艺优化，与分析部门和生产车间紧密合作完成中试生产；
4. 收集、整理实验和工艺数据，编制及撰写并提交相关报告。
5. 领导布置的其他任务。

岗位要求：

1. 硕士以上学历，有机合成，药物合成，化学工艺相关专业；
2. 5年以上药物（有机）合成工作经验，有合成工艺放大经验者优先；
3. 熟悉各种有机合成反应和机理，掌握实验室常用的化合物分离提纯技术和结构鉴定方法；
4. 英语熟练，有团队合作精神。

工作地点: 上海奉贤