自贡招聘

Responsibilities:

Lead the generics and new formulation development teams that involves injectable formulations and other drug delivery systems development

1. Actively involved in selection of injectable generic products to be developed, and IND product development

2. Contribute to budgeting process of injectable product development and ability to operate within budget by maximizing efficiencies and spearhead innovative technologies

3. Work closely with leadership team to meet development project timelines and under budget

4. Conduct literature and patent search from relevant databases to form clear development strategies for different molecules and/or in different disease areas

5. Provide technical oversight, plan, coordinate, and lead a group of scientific staff; troubleshoot on the floor whenever necessary to ensure smooth progress of each project

6. Coordinate with colleagues from different functional groups to prepare technical proposals for new projects and drawing up cost and time estimates of the development work

7. Work with Clinical team to conduct bioequivalence studies, and review results from bioequivalence studies, plan for next steps according to the assessment.

8. Provide technical oversight, plan, coordinate, and oversee all activities related to technical transfers for manufacture of BE batches and also production of validation batches for commercial scale.

9. Ensure compilation of formulation/Process data required for submission of dossiers to meet needs of regulatory agencies, and support Regulatory personnel for dossier submission strategies to regulatory agencies

10. Help Regulatory personnel in answering queries raised by regulatory agencies during the course of registration of products.

11. Manage, recruit, train and retain required staff for injectable product development.

12. Coordinating for projects with different functions within company to ensure smooth movement of projects as per set timelines

13. Provide expert view and support for the GMP manufacturing and/or scale up, tech transfer activities

Qualifications

An ideal candidate should have a Ph.D. degree in Pharmaceutics with at least 10 years experience in pharmaceutical industry and sufficient hands-on experience in injectable product (ANDA) as well as new drug (IND/NDA) development. The title of this candidate depends on the years of experience and accomplishment in pharmaceutical industry.

1. Strong technical expertise in parenteral formulation development, additional experience in complex injectable would be a plus; Demonstrated track record of accomplishments in injectable generic formulation development in terms of ANDA’s/ EU dossier submissions to commercialization of developed products

2. Candidate with experience in advance delivery systems, such as oral, injectables, topical etc will be advantageous.

3. Familiar with pilot and commercial scale of process equipment for solids and/or liquid, experience in handling of technical transfers to pilot scale as well as to commercial scale is required.

4. Must be proficient with the requirements of the FDA/ EMEA, CFDA, cGMP regulations, ICH guidelines as well as generic formulation and new drug development process.

5. Strong problem solving ability, high energy and show willingness to teach associates and to roll-up sleeves on the floor whenever needed

6. Strong interpersonal skills, open exchange of information and teamwork will be required

7. Able to perform the assigned job functions independently with limited supervision from upper management.

8. Skilled in handling multiple projects and prioritizing the workload to meet the pre-determined timelines.

★获得荣誉
中国制药工业百强企业
浙江省医药工业十强企业
国家技术创新示范企业
***企业技术中心
国家环境友好企业
国家高新技术企业
国家创新型企业

★国际化先驱
中国首家 制剂通过美国FDA认证的制药企业
中国首家 在美国获得制剂批准文号的制药企业
中国首家 实现制剂规模化出口美国市场的制药企业
中国首家 挑战美国原研专利成功的制药企业

★国际化成绩
拥有ANDA批准文号最多的中国药企之一
12个产品在美国销售市场占有率***
2018中国西成药出口总额排名***
2019美国仿制药处方量增速***

★国内成绩
一致性评价通过品种数量最多的药企之一
“4+7”带量采购中标品种数量最多的药企

浙江华海药业股份有限公司（股票代码：600521）创立于1989年，总部位于中国浙江。集团现有员工6500多人，在全球拥有40多家分子公司（包括美国、日本、俄罗斯、西班牙、印度等）；业务覆盖化学药、生物药、医药包装、贸易流通等多个领域，与全球500多家制药企业建立了长期合作关系，为近200个国家和地区提供医疗健康产品。集团产品涵盖：心血管、精神类、抗病毒、抗组胺等领域，是全球主要的心血管、精神类健康医疗产品制造商。

作为中国医药国际化先导企业，华海药业是中国首家通过美国FDA制剂质量认证并自主拥有ANDA文号的制药公司，也是首家在美国实现规模化制剂销售的中国制药公司，在世界高端制药市场树立了中国制药品质形象。集团同时凭借自身国际化平台，以运筹全球市场的高度，引领中国其他本土制药公司冲出国门、走向世界，为中国医药行业的崛起而努力。

在中国，华海制剂产品已覆盖国内30多个省市。作为民族药企所肩负的使命，华海药业致力于为中国人民提供国际品质、国产价格的医疗健康产品，服务百姓健康。