北京 [切换城市] 北京招聘北京生物/制药/医疗器械招聘北京生物工程/生物制药招聘

Toxicology Project Management

和铂医药(上海)有限责任公司

  • 公司规模:150-500人
  • 公司性质:外资(欧美)
  • 公司行业:制药/生物工程

职位信息

  • 发布日期:2020-11-11
  • 工作地点:上海-浦东新区
  • 招聘人数:若干人
  • 工作经验:3-4年经验
  • 学历要求:硕士
  • 职位类别:生物工程/生物制药

职位描述

Responsibilities:

  1. Under the supervision and guidance of the ED head, the candidate will serve as a project lead in alignment with the CMC/Discovery teams on developing timeline and providing scientific supports to enable IND preparation and submissions
  2. Will track progress against IND milestone. Serve as a nonclinical safety development and scientific resource
  3. Identify strategic or operational issues impacting plan execution. Ensures that assigned projects are progressed within project timelines and budgetary agreements
  4. Collaborates with other departments for successful completion of all IND enabling nonclinical studies within the defined timelines leading to successful IND filing
  5. May participate in and lead significant process improvement initiatives that may impact the IND development
  6. Be a team player who thrives in an environment where accountability and innovation are critical for success
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Requirements:

  1. MSc or PhD degree with training in a scientific discipline
  2. 3+ years of postgraduate experience in a contract research organization and/or pharmaceutical/biotech setting
  3. Knowledge of nonclinical requirements to support IND filing
  4. Knowledge and understanding of GLPs
  5. Knowledgeable of regulatory requirements, including ICH requirements and CDE requirements. Possesses a basic understanding of guidance that impacts drug development is sought out for advice by others within the department and related functional areas
  6. Experience in nonclinical safety assessment, especially with mAbs is a plus
  7. Good verbal and written communication, excellent interpersonal and information management skills
  8. Collaborate effectively with the study team, cross-functional team members, and external consultants


职能类别:生物工程/生物制药

公司介绍

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.

联系方式

  • Email:joyce.xia@harbourbiomed.com
  • 公司地址:地址:span北京市建国路118号招商局大厦2楼A01室