蚌埠招聘

JOB TITLE : Manager / Senior Manager

REPORT TO (TITLE): Director of Analytical R&D
JOB SUMMARY：
The Analytical Manager is accountable for the development and transfer of test methodology, specifications and regulatory documents associated with drug substance and dosage form development. The Analytical Group collaborates with chemists and formulators, both internally and externally in the development of drug substance and dosage forms. The group provides support for evaluating chemical and physical stability of drug substance, excipients and formulations; collaborates with structural elucidation scientist on the identification of major impurities; provides support for in-vitro drug product performance tests (disintegration, dissolution), uniformity of blends and dosage forms from development, to clinical manufacture, through scale-up and to commercial scale.

KEY RESULT AREAS & JOB ACTIVITIES /TASKS：
1.Accountable for all analytical functions associated with drug substance and dosage form development, understanding, scale-up and transfer

2. Ensure delivery of the portfolio with respect to dosage form development, including formulator

support, development of clinical specifications and development, validation and transfer of

analytical methods

3.Understand local and global regulatory guidance documents and requirements and ensure

deliverables within the group are in alignment with these guidances

4.Identify opportunities for the development/implementation of technology and innovation for

business benefit

5.Strategic planning to ensure analytical capabilities and performance are “best in class” and

well positioned for future success

6. Active career development and mentoring of direct reports

EDUCATION & EXPERIENCE REQUIREMENTS：

MS/PhD in analytical chemistry or related field with 10+ years of experience in the Pharmaceutical Industry.

COMPETENCIES REQUIREMENTS：

1.Well versed in all aspects of Pharmaceutical Sciences with demonstrated understanding of drug substance and drug product aspects of analytical research and development including strategy, method development, specification setting, testing and regulatory filings

2.Expertise in chromatographic separation methodology development and validation (assay, purity)

3.Expertise in analytical drug product performance methodology development and validation (dissolution and disintegration)

4.Experienced in developing and validating stability indicating HPLC methods

5. Well versed in ICH guidances and country specific regulatory requirements

6.Good written and oral communications skills; ability to listen

7. Good collaborative and teamwork skills with demonstration of collaborative relationships

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。