上海招聘

Responsibility：

1. Establish specific in vivo models for different disease indications;

2. Design and execute nonclinical studies conducted in multiple species under non-GLP and GLP conditions;

3. Ensure all preclinical development activities are conducted in line with regulatory standards;

4. Provide scientific leadership in all aspects of preclinical development programs from early in vivo characterization to IND-enabling studies;

5. Lead and work with CROs in assessing PK, PK/PD, target engagement, biomarkers, and toxicology, and establish the safety profile for preclinical development;

6. Generate comprehensive reports that assess the pharmacologic/toxicologic profile of drug candidates, and investigate toxicity relationships;

7. Develop, mentor and guide a top-level, highly effective team.

Qualification:

1. PhD or MD with at least 5 years of drug discovery/drug development experience, applied pharmacology or clinical practice;

2. Strong knowledge of disease models and current clinical treatments;

3. Hands-on experience taking biologics through preclinical development into the clinic;

4. Knowledge of, and experience complying with, the regulatory requirements of operating an in vivo facility and managing various preclinical and toxicological studies;

5. Strong interpersonal skills and proven ability to work effectively in a multidisciplinary team environment;

6. Strong leadership, people development, and influencing skills.

岸迈生物科技（苏州）有限公司是位于苏州工业园区桑田岛产业园的一家新兴的创新型国际化生物技术企业，是上海岸迈生物科技有限公司的生产基地。专注于利用自主知识产权的双特异性抗体技术平台（FIT-Ig®）进行创新生物药的工艺开发及生产。
FIT-Ig®技术是一项新型的双特异性抗体的技术平台，该技术平台能够通过简单的分子生物学手段将两个抗体串联在一起形成双抗，该双抗同时具备了两个原始抗体的功能，拥有双重活性和产业化优势。基于FIT-Ig®平台技术，上海岸迈生物科技有限公司目前拥有十几个自主开发的 First-in-class 生物大分子新药研发项目，专注于恶性肿瘤靶向治疗，肿瘤免疫，T细胞导向治疗等领域。其中已有一个产品处于中美临床试验阶段，多个品种处于临床前开发阶段。
岸迈生物科技（苏州）有限公司承接上海岸迈生物科技有限公司新产品进行工艺开发、临床样品生产、商业化生产活动，预计2020年完成实验室及生产车间的建设。届时将包括一个上下游及制剂工艺开发实验室、一条200L的中试生产线、3个1000L的GMP原液生产线、一条隔离器制剂灌装包装生产线及相应的QC实验室和公用系统。可实现每年超过50批临床前样品、临床样品及商业化产品生产。
岸迈苏州欢迎您的加入！
公司网页：www.epimab.com