长沙招聘

JOB TITLE : Formulation R&D (Associate) Manager

REPORT TO (TITLE): Associate Director of Formulation R&D
JOB SUMMARY：
The primary responsibility of the formulation R&D (associate) manager is to direct and conduct aseptic product development activities.

KEY RESULT AREAS & JOB ACTIVITIES /TASKS：
1.Be responsible for directing and executing aseptic drug product development, process development, process scale-up and technology transfer activities.

2.Create and implement manufacturing batch records, SOPs, stability study and process validation protocols.
Create and justify appropriate product specifications
Prepare regulatory filings
Design, perform and interpret experiments for formulation and/or process qualifications
Prepare, and compile CMC documentation for regulatory filings

3.Prepare, organize and manage execution of technical due diligence plans

4.Foster a culture of high performance, empowerment, collaboration, learning, and diversity.

5.Other duties and responsibilities as required

EDUCATION & EXPERIENCE REQUIREMENTS：

M.S in pharmaceutical sciences with 8-10 years of relevant experience or Ph. D. in pharmaceutical sciences with 3+ years of relevant experience or B.S in pharmaceutical sciences with 15 years of relevant experience. Must have fluent spoken and written English skills.

COMPETENCIES REQUIREMENTS：
1. Ability Functional
1）Experience in drug product development of aseptic products using Quality by Design approach - process development, technical operations, and scale-up manufacturing

2）Experience leading the pharmaceutical development program or project

3）Experience working effectively with domestic and/or international contract manufacturers and suppliers preferred

4）Understanding of the pharmaceutical/biotech industry and regulatory requirements, and meeting country specific regulatory needs

5）Must have 2+ years of experience working in a GMP environment

6）Experience with ANDA filings on very tight timelines a plus

7）Demonstrated evidence of analytical, planning and execution capability

8）Must think critically and creatively, and be able to work independently, determine appropriate resources for resolution of problems, and have strong organizational and planning skills.

9）Exercises independent judgment in developing methods, techniques, and evaluation criteria for obtaining results.

10）Excellent communication skills (both oral and written) and collaborative interpersonal skills are required. Must be able to lead and participate in highly effective teams.

11）Proficiency in all aspects of Microsoft applications (Excel, Word, Project, PowerPoint, etc.)

12）Strong commitment to business ethics

2.Cultural Competencies (Leader Behaviors)
1）Sustain Focus on Performance
2）Manage Change

2012年5月18日，辉瑞制药有限公司与海正制药签署了正式合资经营协议。在获得有关部门的批准后，双方拟建立的合资公司（“海正-辉瑞制药有限公司”）即将正式成立。而合资公司的筹建工作也已紧锣密鼓地展开。辉瑞与海正拥有共同的目标，即共同打造一家一流的中国制药公司，以世界标准运营，为中国和全球市场提供最高质量的品牌制药。为了打造坚实的发展基础，双方将向合资企业注入经过挑选的产品、生产场地、现金和其他相关资产。