广州招聘

岗位职责：

1．组织和规范药品生产企业质量管理工作；负责本企业药品生产全过程包括生产、验证、物料、设施、检验、放行和销售等环节的质量监督管理工作。

2．建立和完善本企业质量管理体系，参加起草、编制、修改、审核各类质量管理工作文件和记录，对该体系进行监控，确保其有效运作；

3．负责新建厂房/车间的申报GMP认证的组织和实施工作；

4．负责检测实验室筹建，新建GMP车间设施布局、设备选型等质量监督和审核；

任职资格：

1．药学或相关专业硕士以上学历，取得国家执业药师资格或中级以上专业技术职称；

2．至少5年以上GMP药厂工作经验：其中3年以上无菌车间生产和质量检验实操经验，2年以上GMP认证的化学原料药或生物制品药厂质量保证工作经验；

3．能承担全面质量管理体系的建设任务，能独立编写质量体系文件和相关GMP认证资料；

4．深刻理解并能熟练掌握2010版GMP规范要求，熟悉GMP认证工作流程；

5．熟悉化学合成原料药、无菌药品、生物制品的生产和质量管理，

6．有合资或外资药品企业认证经验、无菌药品（注射剂）通过2010版GMP认证经验者优；

7．责任心强，具备良好的沟通和协调能力。

百奥泰生物制药股份有限公司（Bio-Thera Solutions, Ltd.）是一家由海外留学归国精英创办的生物制药企业，致力于新一代抗体创新药和生物类似药的研发，用于治疗癌症、自身免疫性疾病、心血管疾病以及其它危及人类生命的重大疾病。
作为新一代抗体药物研发引领者，百奥泰成功搭建了领先的抗体药物技术平台，并建立起丰富的创新药物和生物类似药物产品管线。 在研产品25个，其中8个候选产品处于不同临床阶段。治疗自身免疫疾病的阿达木单抗类似药（原研药为全球“药王”）有望在同类产品中成为中国首仿；治疗心血管疾病的巴替非班是我国第一个针对β3整合素受体的国家1.1类新药。治疗乳腺癌的抗HER2 ADC注射液、治疗多种实体瘤的贝伐珠单抗类似药、治疗自身免疫疾病的托珠单抗类似药已进入Ⅲ期临床。
百奥泰广纳贤才，组建了一支具有丰富生物药物研发和产业化经验的优秀人才队伍。现有员工400余人，硕博士比例高达60%，其中不乏多位资深海外学成归国专家、“千人计划”专家、广东省首批“科技领军人才”、广东省“珠江人才计划”创新创业团队、广州市“百人计划”等优秀成员。
“科学驱动创新，创新只为生命”，百奥泰始终以病人的福祉作为企业的首要核心价值，通过创新研发为病人提供安全、有效、可负担的优质产品，以满足亟待解决的治疗需求。坚持创新，追求卓越，百奥泰部分产品和技术力争成为中国乃至全球的引领者！
Bio-Thera Solutions Ltd, a leading biotechnology company in China, is dedicated to researching and developing innovative and biosimilar therapeutics for the treatment of cancers, autoimmune, cardiovascular diseases, and other serious medical conditions.
Bio-Thera is a leader in next generation antibody discovery and engineering. The company has developed a suite of proprietary technologies for target discovery, antibody engineering and therapeutic development, and antibody manufacturing capability. We have more than 25 research projects, 8 of which are in the clinical stage. BAT1406 was the first adalimumab (global top 1 best-selling drug) biosimilar submitted to CFDA for IND application, and is approaching marketing application submission. BAT2094 is the first class 1.1 new drug targeting β3 integrin in China. Other three programs in late clinical stage are bevacizumab biosimilar for cancer treatment, tocilizumab biosimilar for autoimmune diseases, and BAT8001, an antibody-drug conjugate, targeting HER2 positive cancers.
Bio-Thera built an excellent talent team with biological medicine experience of research and industrialization. The company has nearly 400 staff, the ratio of Master and Dr is as high as 60%, including a number of senior overseas returnee experts, "Thousand Talents Plan" experts, leading talents of Guangdong "Pearl River Talents Plan" innovative entrepreneurial team, "Hundred Talents Plan" experts in Guangzhou and many outstanding members .
"Driven By Science, innovation for life", Bio-Thera has always been to the health of patients as the first core value of enterprise, through innovative research and development for the patient to provide a safe, effective and affordable products, to meet the treatment needs . Persist in innovation and pursue excellence, Bio-Thera’s products and technologies strive to become the leader of China and even the world!