Manufacturing Associate – Purification Process Development
Scope of Position:
Individual is involved in the manufacturing of lentiviral vectors material under cGMP regulatory requirements and supporting the downstream process development for the recovery and purification of vector products. Typically works with bio-hazardous materials. Responsible for performing vector purification and assay experiments, helping to develop and optimize purification processes, supporting product production scale-up, writing and reviewing cGMP documents, and laboratory maintenance.
Major Responsibilities:
· Perform and monitor critical manufacturing processes which may include but not limited to specialized techniques such as depth filtration, chromatography, column packing, tangential flow filtration, centrifugation, and aseptic practices.
· Operate laboratory/bioprocess equipment according to established SOPs including but not limited to tangential flow filtration system, AKTA chromatography system, filter integrity tester, spectrophotometer, HPLC and autoclave.
· Perform buffer preparation, CIP and SIP of process equipment, and general housekeeping of production area.
· Work closely with Materials Management to monitor inventory levels and order materials and supplies in accordance with established policies and procedures.
· Perform analytical procedures, such as ELISA, SDS-PAGE, Western blot, protein assay, PCR, product purity analysis, DNA quantitation and other tasks as needed.
· Analyze and interpret experimental results.
· Complete cGMP documentation and maintain accurate laboratory notebook and records.
· Draft, revise and review Standard Operating Procedures/Manufacturing Procedures.
· Comply with current Good Manufacturing Practices regulations.
Experience and Qualifications Requisite for Position:
· Theoretical knowledge and practical experience in chromatography and filtration development is preferred. Expertise with AKTA platform and Unicorn software is a plus.
· Strong organization skills and detail-orientation.
· Ability to multi-task and work effectively in a team environment.
Educational Requirements:
B.S. or M.S. in a scientific discipline
If you qualify, let us know by e-mailing your CV and references to: E-mail: employment@virxsys.com.