上海招聘

Job Responsibilities

1.         Supervision of upstream cell culture team. Organizing and participating work packages within the team regarding vial thaw, seed train, IPC, Fermentation, media and solution prep and harvest including change-over, scale up. Ensure safe processing and safe handling within his/her team.

2.         Expert for Cell Culture and related equipment within GMP requirements. Power user of SUB and FlexAct (Sartorius) systems as well as other relevant equipment used in company. Support trouble shooting and problem solving whenever needed.

3.         Support during establishment of process transfer concepts, establish relevant documents (PD, parameter list, Risk assessments, reports, BOM).

4.         Ensure Good Documentation Practice in daily work life of USP Cell Culture team. Supervise implementation of process related change controls, CAPAs, Risk assessments and investigations. Supervise batch document review.

5.         Ensuring good communication, material and data hand over with internal and external customers. Representing Upstream as team member in commercial product teams and towards external customers. Support connection to skill centers in Biberach, Fremont and Shanghai to align processes and transfers.

6.         Organize and handle materials in production area as well as GBS system and keep the BOM updated.

Qualifications

1.         Degree: Bachelor/Master

2.         Major: Biotechnology, Bioengineering, Biopharmaceuticals, Biology, Biochemistry

Required skills:

3.         Knowledge about fermentation and upstream processing

4.         Knowledge and understanding of cGMP and documentation according to GMP

5.         Good understanding of organizing a lab

6.         Practical experience with fermentation and related analytical methods (e.g. cell counter, analysis of metabolites)

7.         Knowledge of the actually used equipment and systems in China, such as disposable bioreactor and FlexAct

8.         Analytical and scientific thinking, clear argumentation and ability to reduce complex issues to the main points

9.         Self confidence

10.     Social competence, customer orientation and team player

11.     This individual will be goal-oriented and focused on meeting deadlines in the required quality within a highly competitive environment

12.     This individual will work hands-on in a cGMP laboratory and also perform cGMP documentation, shift work and week end work will occur on periodic basis

13.     Experience in inoculums, scale-up, fermentation, harvest. Capability to become a highly motivated team player and to move up as a expert for upstream process.

14.     Language skills & proficiency: English (oral and written) and Chinese (fluent)

15.     Required experience: GMP, Upstream process related equipment, process understanding

16.     Years of leadership experience: 1-2 years

上海锴烜资产管理有限公司于2014年，多年来一直致力于私募基金的投资和管理。