Essential Functions of the Job:

Perform as assistant functions in the qualification of MFG-USP area and equipment, as well as the GMP facility commissioning;

Manufacture clinical and commercial material according to schedule which is compliant with cGMPs and safety regulations;

Ensure operations are carried out according to documentation (batch records and SOPs);

Responsible for the accurate, safe, environmentally friendly, and quality compliant operations of the upstream manufacturing process;

Perform as assistant functions for creation and on-going maintenance of all MFG-USP related equipment, policies, and procedures;

May author URS, MBR and other technical documents;

Other reasonably duties as requested by Company Senior Management from time to time.

Education Required:

Major in Biopharmaceutics, Bioengineering, Bioprocess or other related fields.

Essential Experience:

College degree or above and at least 1-year experience in biopharmaceutical based GMP manufacturing;

Hands-on experience in operating disposable bioreactors at scale over 500L in GMP facility;

Good oral and written communication skills. Technical writing ability is required;

Advanced computer system skills for Microsoft Office suite (Word, Excel, PowerPoint, Project, Outlook).

Essential Functions of the Job:

Operate and maintain the vial washing machine, tunnel, filling machine, capping machine, Autoclave and other equipment according to the post SOP;

Participate in filling and capping operations and ensures scheduled activities are performed as planned;

Fill in MBR, equipment and other auxiliary records as required by SOP;

Participate in investigation of the deviation, change and quality risks in production process;

Take responsibility of the general operation and maintenance of the fill finish facilities and equipment;

Maintain effective, collaborative, and frequent interactions with other departments to ensure harmonization in scientific and technical approaches;

Other reasonably duties as requested by Company Senior Management from time to time.

Education Required:

Major in Pharmaceutics, Pharmaceutical Science or related field;

Advanced post-graduate qualification (CS，BS or Master) related to bioprocessing or biopharmaceutical production.

Essential Experience:

CS degree with a minimum of 0~3 years and BS or Master degree with a minimum of 0~2 years of pharmaceutical fill finish experience; Experience in aseptic production in Grade B area is preferred;

Master the theoretical knowledge of pharmaceutical;

Ability to bear certain stresses. Advanced computer system skills for Microsoft Office suite (Word, Excel, Powerpoint, Project, Outlook).

Essential Functions of the Job:

Responsible for downstream production and ensure scheduled activities are performed as planned;

Improve production process of downstream to make operation more reasonable;

Familiar with purification，filtration and bulk filling. Make sure the equipment to work smoothly;

Have skills to draft documents, such as general documents, SOP, BPR and so on;

Staff training and safety management;

Investigate and handle the deviation, change and quality risks in production process;

Take responsibility of the general operation and maintenance of the downstream MFG facilities and equipment;

Maintain effective, collaborative, and frequent interactions with clients and other departments to ensure harmonization in technical approaches;

Other reasonably duties as requested by Company Senior Management from time to time.

Education Required:

Major in Pharmaceutics, Pharmaceutical Science or related field;

Advanced post-graduate qualification (BS or Master) related to bioprocessing or biopharmaceutical production.

Essential Experience:

BS degree with a minimum of 1~2 years of pharmaceutical downstream manufacture experience;

Expert knowledge in downstream MFG related to purification process and GMP quality request of MAbs and recombinant proteins;

Advanced computer system skills for Microsoft Office suite (Word, Excel, Powerpoint, Project, Outlook);

Thorough practical knowledge of Chemistry Manufacturing and Controls for IND/CTA filing in China, USA and EU.