下游生产主管-宁波

1.Familiar with downstream production process, including the organization and implementation of solution preparation (Small molecule process), virus inactivation, affinity chromatography, ion exchange chromatography, virus filtration, ADC conjugation, ultrafiltration, bulk filling and other processes, Responsible for organizing and leading the members to complete downstream production according to SOP;

2.Responsible for organizing team members to clean personnel, materials and equipment to meet production requirement;

3.Assist leaders in 5S management and environment cleaning of the production site, ensure the production site clean and orderly;

4.Responsible for drafting and updating batch production records, relevant production technical documents, production operation documents;

5.Assist leaders in process control and risk control of downstream drug substance production;

6.Participate in process optimization and continuous improvement, solve technical problems encountered in the production process;

7.Responsible for connecting with warehouse, equipment and other departments to ensure that materials and equipment meet production requirement;

8.Responsible for starting, improving and executing the deviation, change control and CAPA of downstream area;

9.Participate in technology transfer of downstream production-related products;

10.Participate in the purchase, acceptance, installation, test and IOPQ of equipments for downstream drug substance production, Draft URS and SOPs, supervise routine cleaning, maintenance, and timely repair and follow-up.

Job Requirement:

1.Pharmaceutical related major, regular bachelor degree or above, 3 years above working experience in DSP related positions;

2.Familiar with the theoretical knowledge of biological macromolecule and small molecule drug production;

3.Familiar with relevant GMP regulations;

4.Good interpersonal skills;

5.Basic English reading and writing ability;

6.Working experience in GMP workshop is preferred;

7.Working experience in commercial production is preferred.