Job Responsibilities
Implement validation master plan and organize relevant departments to complete the validation plan;
Participate in the investigation of deviations arise from validation and qualification within the scope of responsibility;
Prepare and draft validation protocol and report for relevant department;
Review validation protocol and report of department;
Periodical filing of validation report.

Job Requirements
 Bachelor degree or above in medicine, pharmacy, biology, chemistry, immunology and other majors
 At least 2 years of experience in production or quality in biological or sterile preparations;
 At least 2 years of experience in validation implementation or document review in biological or sterile preparations;
 Experience in EU and FDA certification is preferred.

Job Responsibilities
 Responsible for the activity research of macromolecular protein drugs, including the development, validation, sample test and technology transfer of activity research methods, and lead the team in fulfillment of activity research in strict accordance with the project schedule.
Responsible for the management of preclinical pharmaceutical research of macromolecular protein drugs, support the process development, and ensure the project completes the IND application within the specified time.
Establish a research team for biological activity of macromolecular protein drugs, build up and be responsible for daily management of activity research, management and maintenance of SOP, maintenance of instruments and equipment, and personnel training.
Responsible for department management (attendance management, KPI assessment, promotion assessment, daily rewards of employees, etc.).

Job Requirements
 Bachelor degree or above in medicine, pharmacy, biology, chemistry, immunology and other related majors
Experienced in chemical/biological drug producers

 Over 3 years of experience

Job Responsibilities

Carrying out daily production operation according to the task assigned by the department leader;

Carrying out production operation in accordance with SOP and various requirements;

Cell harvest, culture, preparation (passage, thawing) and storage according to production task, SOP or technical requirements;

Strictly abide by the requirements in production safety, comply national, local, and internal laws and regulations;

Cleaning, sterilization, and maintenance of production equipment and production plant;

Truthfully fulfill production record, and other production-related work.

Job Requirements

Bioengineering, cell biology and other pharmaceutical-related majors;

College degree or above;

Experience in bioreactor operation is preferred;

Over 2 years of experience;

Comprehension of GMP and related laws and regulations, sterility awareness.