高级研发工程师(Sr.Process Development Scientist)
武汉中原瑞德生物制品有限责任公司WuhanUpdate time: May 16,2019
Job Description
武汉市

Job Description:

1.Supporting the performance of Process Development studies.

2.Creating experimental protocols, performing and supervising experiments and study related documents. Release of study results.

3.Provide support for Technical Operations or improvement of plasma derived products in manufacturing.

4.Support Process Development activities in routine business within in defined timelines.

5.Define equipment, PCPs and PQAs for experiments.


6.Creating experimental protocols, performing and supervising experiments and designs. Preparing, processing, monitoring, documenting and evaluating complex down/ kilo/ pilot plant scale experiments, e.g. process development, operating machines and/or characterization of intermediates.

7.Developing and optimizing process designs.

8.Preparing documents like SOPs, test instructions, testing plans, specifications, result/ study reports


9.Compiling and presenting results.


10.Compiling regulatory documents.

11.Develop and maintain facilities, laboratories and equipment to the required quality standards (as appropriate for GSP, GLP or GMP).

12.Selecting equipment for purchase, writing user requirements and preparing orders

13.Managing sourcing, collection, preparation and distribution of samples also in coordination with other areas e.g. Production, CRD, ASQ


Job Requirements:

1.Academic scientific qualification, e.g. Master of Science in Biochemistry or corresponding area of Chemistry or Biology with 3-5 years of work experience in R&D, e.g. also covered by a doctoral thesis.


2.Strong scientific background in coagulation, immunology, intensive care medicine, aspects of protein biochemistry, protein purification, CSL Behring’s plasma protein products and manufacturing processes, protein analytics and quality assurance.


3.Proven ability to work efficiently, both independently or in a team setting, and met set goals by managing own timelines.


4. Experience in working in cross-functional, multicultural and international teams.


5.Experience in project work. Excellent communication (written and oral) and analytical skills.


6. Strong planning and organizational skills. Fluent in English, oral and written.

7.Work well within a fast-paced, dynamic and team-oriented environment


8.Management of laboratory projects


10.Compiling regulatory documents.

职能类别: 生物工程/生物制药 医药技术研发人员

关键字: 生物制药 工艺开发 GMP

微信

联系方式

上班地址:武汉东湖新技术开发区光谷生物城光谷七路99号

Get email alerts for the latest"高级研发工程师(Sr.Process Development Scientist) jobs in Wuhan"