制剂高级研究员Senior Scientist
海正辉瑞制药有限公司
- 公司规模：1000-5000人
- 公司性质：合资(欧美)
- 公司行业：制药/生物工程
职位信息
- 发布日期：2015-04-08
- 工作地点：上海-松江区
- 招聘人数：2
- 工作经验：2年
- 学历要求：本科
- 职位月薪：面议
- 职位类别：医药技术研发人员
职位描述
JOB TITLE : Senior Scientist
REPORT TO (TITLE): Manager of Formulation R&D
JOB SUMMARY
The primary responsibility of the Senior Scientist is to direct and conduct product development and project transfer activities.
KEY RESULT AREAS & JOB ACTIVITIES /TASKS
Be Responsible for directing drug product development, process development, process scale-up and technology transfer activities.
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
Compile CMC documentation for regulatory filings
Prepare, organize and manage execution of technical due diligence plans
Foster a culture of high performance, empowerment, collaboration, learning, and diversity.
Other duties and responsibilities as required
EDUCATION & EXPERIENCE REQUIREMENTS
1, Educational /Training and working experiences
M.S in pharmaceutical sciences with 5-7 years of relevant experience or Ph. D. in pharmaceutical sciences with 2 years of relevant experience or B.S in pharmaceutical sciences with 10 years of relevant experience
COMPETENCIES REQUIREMENTS
1.Ability Functional
Experience in drug product development of solid oral dosage form preferably tablets and using Quality by Design approach - process development, technical operations, and scale-up manufacturing
Experience in depth knowledge of pharmaceutical principles for injectable dosage forms with experiences in pre-formulation and formulation/process R&D for small and macro-molecule drugs
Experience completing the pharmaceutical development program or project with minimum guidance
Experience working effectively with domestic and/or international contract manufacturers and suppliers preferred
Understanding of the pharmaceutical/biotech industry and regulatory requirements, and meeting country specific regulatory needs
Must have experience working in a GMP environment
Experience with ANDA filings on very tight timelines a plus
Demonstrated evidence of analytical, planning and execution capability
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.
Exercises independent judgment in developing methods, techniques, and evaluation criteria for obtaining results.
Excellent communication skills (both oral and written) and collaborative interpersonal skills are required. Must be able to lead and participate in highly effective teams.
Proficiency in all aspects of Microsoft applications (Excel, Word, Project, PowerPoint, etc.)
Strong commitment to business ethics
2.Cultural Competencies (Leader Behaviors)
Sustain Focus on Performance
Manage Change
REPORT TO (TITLE): Manager of Formulation R&D
JOB SUMMARY
The primary responsibility of the Senior Scientist is to direct and conduct product development and project transfer activities.
KEY RESULT AREAS & JOB ACTIVITIES /TASKS
Be Responsible for directing drug product development, process development, process scale-up and technology transfer activities.
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
Compile CMC documentation for regulatory filings
Prepare, organize and manage execution of technical due diligence plans
Foster a culture of high performance, empowerment, collaboration, learning, and diversity.
Other duties and responsibilities as required
EDUCATION & EXPERIENCE REQUIREMENTS
1, Educational /Training and working experiences
M.S in pharmaceutical sciences with 5-7 years of relevant experience or Ph. D. in pharmaceutical sciences with 2 years of relevant experience or B.S in pharmaceutical sciences with 10 years of relevant experience
COMPETENCIES REQUIREMENTS
1.Ability Functional
Experience in drug product development of solid oral dosage form preferably tablets and using Quality by Design approach - process development, technical operations, and scale-up manufacturing
Experience in depth knowledge of pharmaceutical principles for injectable dosage forms with experiences in pre-formulation and formulation/process R&D for small and macro-molecule drugs
Experience completing the pharmaceutical development program or project with minimum guidance
Experience working effectively with domestic and/or international contract manufacturers and suppliers preferred
Understanding of the pharmaceutical/biotech industry and regulatory requirements, and meeting country specific regulatory needs
Must have experience working in a GMP environment
Experience with ANDA filings on very tight timelines a plus
Demonstrated evidence of analytical, planning and execution capability
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.
Exercises independent judgment in developing methods, techniques, and evaluation criteria for obtaining results.
Excellent communication skills (both oral and written) and collaborative interpersonal skills are required. Must be able to lead and participate in highly effective teams.
Proficiency in all aspects of Microsoft applications (Excel, Word, Project, PowerPoint, etc.)
Strong commitment to business ethics
2.Cultural Competencies (Leader Behaviors)
Sustain Focus on Performance
Manage Change
公司介绍
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。