北京招聘

  

1. Lead/ assist analytical team to develop physiochemical and functional assays to support process and product development as well as product release.

2. Manage /perform analytical experimental design, execution and writing testing methods and qualification protocols/reports.

3. Work closely with other CMC colleagues to ensure timely analytical support for cell line, process and formulation development.

4. Oversee /contribute comparability strategies and CQA assessments

5. Provide supervision for assay transfer and oversee CMO activities.

6. Review and approve qualification reports and QC SOPs; address testing related issues at CMO's in collaboration with Quality.

7. Manage/contribute reference standards and oversee critical reagent strategy.

8. Manage/coordinate Analytical Development resources and strategic planning to support early and late stage projects.

9. Drive innovation through deep understanding of new technologies and methods in analytical development

10. Coordinate and collaborate with Discovery and other CMC functions and develop strategies to meet project as well as corporate timelines

11. Contribute to the IND filings

                      

  

Requirements:

  

1. BS/BA or MS or PhD in Chemistry, Analytical Chemistry, Chemical Engineering, Biotechnology, Biochemistry or related field. Number of years of industry experience commensurate with job titles

2. Hands on experience on analytical technologies such as HPLC, CE, peptide map, mass spectrometry, ELISA, MS, and cell-based bioassay

3. Significant experience with protein characterization and comparability assessment is essential

4. Direct experiences on transfer of analytical methods to CMO's and in authoring analytical sections for regulatory submissions preferred

5. Experiences with method validation, process validation and BLA submission is preferred

6. Leadership experience with proven capability as a successful leader in a strategic multifunctional environment is plus

7. Knowledge of cGMP's, regulatory guidelines, validation practices, and other relevant regulatory requirements.

8. Extensive knowledge and experience in IND filing

9. Must be scientifically knowledgeable, team-orientated, and passionate about biopharmaceutical development

10. Excellent interpersonal communication and presentation skills. Ability to work independently and multitask in a fast-paced environment

11. Responsible, organized and disciplined record keeping

12. Self-motivated, collaborative, and effective communication skill

                        

和铂医药是一家专注于肿瘤免疫领域创新药物研究与开发的全球化运营生物医药公司。公司将运用其拥有的全部自主知识产权的全人源单抗的转基因鼠系列核心技术平台，建立下一代治疗性肿瘤抗体药物产品管线,并将围绕Harbour的两大平台拓展合作与授权业务。公司总部及研发基地位于中国上海，另外在美国马塞诸塞州剑桥设立商业运营中心，在荷兰鹿特丹设立抗体研发平台创新中心，在波士顿地区设立了创新中心包括实验室和研发团队，也将在江苏昆山设立研发基地。公司拥有资深管理团队以及丰富的药物研究与开发经验。和铂医药要为满足中国及全球病人的需求而不断努力，依托拥有自主知识产权的核心技术平台,创建一个在肿瘤治疗领域有科学与技术领导力的国际性生物医药公司。同时, 在药物研发领域建立以技术平台为基础的对外合作，整合新的技术，推动中国整个抗体研发产业的进步。

Company Overview
Harbour BioMed is a global biotechnology company discovering and developing innovative therapeutics for cancer with a focus on immuno-oncology and autoimmunity/inflammation. The company's discovery and development programs are centered around its two patented transgenic mouse platforms for human antibody discovery.
The company is building its proprietary pipeline internally, through collaborations with co-development partners, as well as through selective preclinical and clinical stage asset acquisitions. Harbour BioMed also licenses the platforms to companies and academic institutions through its Harbour Antibodies subsidiary.
Harbour BioMed has headquarters and an R&D site in Shanghai, business operations in Cambridge, MA, and antibody platform development in Rotterdam, The Netherlands.
The company has an innovation center including research lab and a development team in Boston. Also, we are expanding to Kunshan site in Jiangsu for our R&D operation.