Purification/Formulation Biochemist III

Job Summary:  MAJOR RESPONSIBILITIES: * Purifies monoclonal antibodies from serum/ascites fluid and tissue culture supernatant by appropriate serum fractionation and/or column chromatographic techniques. Monitors purification process at several stages to maximize yield and degree of purity of antibody.
* Formulates monoclonal antibodies reagents.
* Performs cleaning, inspection, verification for calibration and maintenance of equipment. Maintains related logs and records. Performs equipment troubleshooting.
* Completes materials movement transactions on SAP system and performs the required inventory control activities to maintain accuracy.
* Maintains detailed production records.
* Schedules daily assignments for less experienced technicians.
* Develops and revises Standard Operating Procedures (SOP’s).
* Provides training to other associates when required.
* Provides in-process testing as required.
* Generates Quality Reports such as Deviations Reports, etc.

REQUIREMENTS:

* Bachelor Degree in a related scientific discipline (such as Chemistry, Biochemistry, Biology, Microbiology or Engineering) and six years of experience in a pharmaceutical/medical device/biotechnology environment or equivalent combination of related education and experience.
* Knowledge in the purification of monoclonal antibodies from serum/ascites fluid and tissue culture supernatant by appropriate serum fractionation and/or column chromatographic techniques.
* Knowledge in the formulation of monoclonal antibodies reagents.
* Knowledge of the operation of related instrumentation such as Mixing, HPLC (High Pressure Liquid Chromatographer), microscopes, Spectrophotometer, Flow Cytometors, Conductivity, Bipass Columns, Centrifuges and I&F (Isoelectric Focusing).
* Knowledge of GMP, FDA, ISO and OSHA requirements.
Working knowledge on MS Windows environment software such as MS Office.
* Effective skills on analytical thinking, problem solving, interpersonal relationships, written and oral communication, and planning/organization.
* Fully Bilingual (English and Spanish).
* Willing to travel to US mainland and offshore.