The GMP Specialist II Downstream’ s primary purpose is to purify biological products under cGMP environment. The candidate is expected to have good purification and aseptic technique including experience using BSC as well as gowning experience under cGMP condition.

The GMP Specialist II will work on downstream purification of biological products including but not limited to protein, antibody and viral vectors. The essential functions comprise buffer preparations, operating chromatography instruments and columns, assembling and performing normal and tangential-flow filtrations and participating in process improvement following GMP procedures. Regular duties include execution of downstream (purification) batch records, preparation of buffers, maintenance of room and instruments, updating and improving GMP documents and participating in other required GMP activities. Experience with downstream purification techniques is required. The Specialist II will operate and maintain general production equipment such as chromatography skids, TFF systems and cassette holders, filtration cassette holders, Autoclaves, Scales, pH/conductivity meters, centrifuges etc. Document activities in batch records and relevant logbooks according to cGMP regulations and ABL procedures.

• Perform purification of viruses, viral vectors and proteins using various column chromatography following established SOPs and BRs.
• Perform column packing and qualifications of various resins.
• Operate and maintain chromatography skid, such as AKTA series using Unicorn software.
• Perform TFF and/or UF/DF, and various filtration methods.
• Perform Aseptic technique in Biological Safety Cabinets and Laminar Air Flow.
• Perform integrity testing on various types of filters.
• Update batch records and SOPs for the downstream operations in collaboration with supervisor and QA personnel.
• Review documentation and check all calculations (e.g. tickets, labels, equipment reading).
• Occasional overtime and weekend work is required.
• Collaborate with team members as well as members of other departments involved in GMP manufacturing for planning production, testing and product release in a timely manner resulting in successful completion of projects.
• Participate in technology transfer of processes from Process Development to Manufacturing.
• Work cross functional with the upstream and fill/finish group to provide resources as needed.
• Perform tasks under minimal supervision, and within tight time lines to meet production schedules.
• Other duties as assigned

• Bachelor’s degree
• 2+ years of experience in the cGMP Biomanufacturing
• 1+ years of experience with downstream cGMP Manufacturing is required.
• Experience with GDP
• Intermediate computer skills using MS Office (Word, Excel, and PowerPoint) required.
• Possess excellent interpersonal skills, both communications and written. The candidate in this position must be able to communicate effectively with Management and staff.
• Team-player, organized, detail-oriented, self-motivated with ability to multi-task.
• Responsible and takes initiative