北京招聘

Responsibilities:

1.    Oversee the validation and sample analysis of PK, ADA and NAb analysis.

2.    Ensure work is conducted in accordance with worldwide regulatory authorities.

3.    Responsible for the scientific oversight of bioanalytical projects within a team.

4.    Monitor projects and review method validation plan/sample analysis plan, review reports generated by the group and CROs for scientific accuracy and completeness.

5.    Provide scientific input and oversight on PK/ADA/NAb sample collection, shipment and storage, sample analysis, and return of data per study timeline.

6.    Develop bioanalysis method and hands on analysis of pre-clinical PK/ADA samples

7.    Participate in meetings and other activities of project teams, working groups, and other relevant groups as needed to contribute to projects.

8.    Have and maintain understanding of current international guidelines and expectations governing regulated bioanalysis.

 

Requirement:

Required Educational Background and Job-Related Experience

1.    Bachelor degree (BS/BA) in the sciences with 5+ years' experience, Master (MS) degree in the sciences with 3+ years' experience and Doctorate (PhD) degree in the sciences with 1+ year experience in a GLP compliance laboratory environment.

2.    Bioanalysis experience especially for large molecules. A diverse skillset in bioanalytical assay development methodologies such as ligand binding (ELISA, MSD, etc.) and LCMSMS.

Knowledge & Skills Required

3.    Bioanalysis: Familiar with bioanalytical techniques and challenges, demonstrated hands-on experience and technical knowledge in bioanalytical assays

4.    Scientific: Working knowledge of immunoassays, quantitative (PK) and immunogenicity

5.    Project management: detail oriented and highly organized

6.    Efficiency: must work effectively within the team to meet objectives under time constraints.

7.    Quality: experience in a GLP environment and demonstrated knowledge of GLP regulations, regulatory expectations (FDA, EMA, Asia-Pacific) and industry best practices for bioanalysis.

8.    Multi-task: ability to take direction well and manage a diverse workload.

9.    Communication: excellent oral and written communication skills.

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.