1．研发总监（Director of R&D）  ：

岗位职责：

负责规划、管理、实施和督导整个公司的研发项目计划；管理研发团队；建立或完善公司的研发体系；按时高质量完成公司的研发任务；完成总经理交待的其它工作。

任职资格：

（1）在美国的大学获得药学、生物学、生物医学或生物技术相关专业博士学位；

（2）在美国生物制药界有10年以上的药物研发领域工作经验，开发过蛋白质药物或做过单抗药物的CRO服务，做过Principal Scientist or Senior Scientist, great tracking records；

（3）拥有良好的蛋白质化学、生物化学、细胞生物学或免疫学功底，工业经验可以集中在单抗药物开发、蛋白质纯化分析、哺乳动物细胞培养和工艺放大、药理学研究等。

（4）具有丰富的研发项目管理经验；熟悉完整的生物类药品研发流程和临床报批内容及程序；熟悉FDA申报法规；

（5）具有丰富的研发团队管理和培养经验；

（6）具有优秀的领导、组织、判断、决策、协调和影响能力，出色的团队管理能力，

（7）具有高度的责任感、职业道德、敬业精神和契而不舍的工作精神，真心热爱药物研发。

（8）拥有不断地了解和追踪相应的学科进展和国际国内最新的研究及项目进展的自我驱动力；

（9）具有出色的英文和中文的听说读写能力；有杰出的撰写科研报告和科研项目申报书的能力。

2．细胞培养工艺开发经理（Manager of Process Development）:

岗位职责:

负责公司的单抗药物的表达生产的小试和中试的工艺放大和优化，尤其是CHO细胞悬浮培养、细胞培养条件的优化、中小规模的发酵工艺开发。Be involved in the development and characterization of recombinant cell culture processes from cell line generation to bench scale production.  This important role requires biological and engineering expertise to develop cell lines and optimize the processes that will ultimately be suitable for cGMP production.  具体的职责包括但不限于：

(1) To develop technologies to enhance the cell line and cell culture expression platform;

(2) To lead tech transfer activities and provide on-site and on-floor cell culture support for the cGMP facility;

(3) To develop & optimize cell culture processes for IND-enabling projects per China/US/EU regulatory requirements;

(4) To develop & optimize late-stage (Phase II/III) cell culture processes, including design and execution of process characterization and validation studies.

任职资格：

(1) Ph.D. degree in biological sciences and at least 6 years industry experience, or MS degree and at least 10 years industry experience;

(2) Must have hands-on mammalian cell culture process development experience for protein therapeutics (preferably monoclonal antibodies), and have strong expertise in process optimization, scale-up and technology transfer;

(3) Experience with medium optimization, DoE studies, regulatory submission to the FDA/EMEA and personnel management is a plus;

(4) 具有出色的英文写作能力暨撰写英文科研总结报告的能力；良好的中文的听说读写能力;

(5) 具有出色的管理和协调能力;

(6) 具有高度的责任感、职业道德、敬业精神和契而不舍的工作精神。

3. 毒理和药理临床前研究经理（Manager of Preclinical Toxicology & Pharmacology）:

岗位职责：负责公司的药物的药理、毒理和药效的临床前研究。Responsible for the oversight of the development of pre-clinical strategies of pharmacology & toxicology – from lead optimization to product approval of molecules in the development pipeline in a multi-disciplinary team environment. 具体的职责包括但不限于：

(1) Design and management of nonclinical studies and overall IND enabling program;

(2) Initiate and manage contracts, coordinate activities, and manage selected CROs for preclinical development in the areas of toxicology and pharmacokinetics;

(3) Provides preclinical expertise, strategy and work closely with other functional areas, particularly in DMPK, pharmacology and animal models;

(4) Critically review and edit CRO study reports, analyze and interpret data and coordinate report finalization;

(5) Communicate toxicology study findings to project teams;

(6) Prepare and edit non-clinical documents for regulatory submission (e.g.  INDs, IB’s, and regulatory briefing documents);

(7) Maintain a current understanding of and ensure compliance with GLP, GMP, GCP and regulatory guidelines.

任职资格：

(1) Ph.D in pathology, pharmacology, physiology or related discipline; DABT preferred;

(2) Minimum of 5 years hands-on expertise in pharmaceutical toxicology/safety assessment and drug development;

(3) Experience with small molecules, participation on drug development and IND submissions;

(4) Experience in designing, monitoring and interpreting non-clinical safety studies;

(5) Excellent communication, collaboration and multi-tasking skills;

(6) Demonstrated proficiency in nonclinical study design and management;

(7) Mastery of preclinical drug development, strategy, practice and FDA regulations absolutely essential;

(8) Knowledge of CFDA regulations is a plus; 能够计划、组织实施和撰写相关申报材料 to CFDA;

(9) 具有出色的英文写作能力暨撰写英文科研总结报告的能力；良好的中文的听说读写能力;

(10) 具有出色的管理和协调能力;

(11) 具有高度的责任感、职业道德、敬业精神和契而不舍的工作精神。