Material Preparation per established procedures.

Perform inspection, verification for calibration and maintenance of equipment. 

Maintains related logs and manufacturing records. 

Performs area in-process testing as requested.

Reclaim and re-test of resins.

Performs daily working area cleaning tasks.

Performs packing, cleaning and equilibration of chromatography columns as requested and scheduled.

Maintains inventory of chemicals and lab supplies required for manufacture. Completes material order transactions in SAP system and performs the required inventory control activities to maintain accuracy.

Support set up and manufacturing activities for the following areas: tissue culture, purification and conjugation.

Processes cell supernatant to remove debris and to concentrate product before purification.

Formulates monoclonal antibody reagents using established documentation. 

Manufactures buffers and solutions using established procedures. 

Uses equipment such as pipettes, micro-pipettes, balances, pH and conductivity meters, and UV/Visible spectrophotometers.

Completes assigned manufacturing tasks.

Complete Filling & Packaging process by scheduling, filling, labeling, bagging, pouching and vialing for:  pellets, purified and conjugated materials, as required.

Promotes a safe work environment by providing recommendations on maintaining the safety of the work environment, following safety procedures, participating in Environment Health and Safety (EH&S) programs, initiating a corrective action whenever a hazard is identified, notifying supervisor of all observed hazardous conditions or unsafe work practices.

Supports Quality Assurance by keeping abreast of the basic requirements for compliance in own area of work and aligns with those requirements, participating as required in training on regulatory issues affecting own area of work, bringing regulatory compliance questions/issues to next level of management.

Maintain good housekeeping practices.

Provide recommendations to support systems that continuously improve product/process quality and product availability, reduce cost, and increase production capability.

Participates in Continuous Improvement initiatives.

Performs other related duties and assignments as required.

Knowledge of aseptic techniques.

Knowledge of methods required to perform in process testing.

Knowledge of the operation of related instrumentation such as Spectrophotometers, centrifuges, balances, conductivity meters, micropipettes, CO2 Incubators, Microscopes Micro plate readers, centrifuges, pipettes and Biosafety Hoods

Knowledge in the manufacture of dilutions, buffers and solutions.

Strong Mathematics skills. 

Knowledge of GMP, FDA, ISO and OSHA requirements highly desirable.

Working knowledge on MS Windows environment software such as MS Office. 

Effective skills on interpersonal relationships, written and oral communication, and planning/organization.

Demonstrated ability to follow established policies and procedures. 

Ability to speak, read and write English. 

Ability to speak, read and write Spanish. 

Attendance and punctual

Associate Degree is minimum requirement

Minimum of one year of experience in a laboratory or pharmaceutical/medical device/biotechnology environment or equivalent combination of related education & experience (i.e. BS w. 6 months experience).

Material Preparation per established procedures.

Perform inspection, verification for calibration and maintenance of equipment. 

Maintains related logs and manufacturing records. 

Performs area in-process testing as requested.

Reclaim and re-test of resins.

Performs daily working area cleaning tasks.

Performs packing, cleaning and equilibration of chromatography columns as requested and scheduled.

Maintains inventory of chemicals and lab supplies required for manufacture. Completes material order transactions in SAP system and performs the required inventory control activities to maintain accuracy.

Support set up and manufacturing activities for the following areas: tissue culture, purification and conjugation.

Processes cell supernatant to remove debris and to concentrate product before purification.

Formulates monoclonal antibody reagents using established documentation. 

Manufactures buffers and solutions using established procedures. 

Uses equipment such as pipettes, micro-pipettes, balances, pH and conductivity meters, and UV/Visible spectrophotometers.

Completes assigned manufacturing tasks.

Complete Filling & Packaging process by scheduling, filling, labeling, bagging, pouching and vialing for:  pellets, purified and conjugated materials, as required.

Promotes a safe work environment by providing recommendations on maintaining the safety of the work environment, following safety procedures, participating in Environment Health and Safety (EH&S) programs, initiating a corrective action whenever a hazard is identified, notifying supervisor of all observed hazardous conditions or unsafe work practices.

Supports Quality Assurance by keeping abreast of the basic requirements for compliance in own area of work and aligns with those requirements, participating as required in training on regulatory issues affecting own area of work, bringing regulatory compliance questions/issues to next level of management.

Maintain good housekeeping practices.

Provide recommendations to support systems that continuously improve product/process quality and product availability, reduce cost, and increase production capability.

Participates in Continuous Improvement initiatives.

Performs other related duties and assignments as required.

Knowledge of aseptic techniques.

Knowledge of methods required to perform in process testing.

Knowledge of the operation of related instrumentation such as Spectrophotometers, centrifuges, balances, conductivity meters, micropipettes, CO2 Incubators, Microscopes Micro plate readers, centrifuges, pipettes and Biosafety Hoods

Knowledge in the manufacture of dilutions, buffers and solutions.

Strong Mathematics skills. 

Knowledge of GMP, FDA, ISO and OSHA requirements highly desirable.

Working knowledge on MS Windows environment software such as MS Office. 

Effective skills on interpersonal relationships, written and oral communication, and planning/organization.

Demonstrated ability to follow established policies and procedures. 

Ability to speak, read and write English. 

Ability to speak, read and write Spanish. 

Attendance and punctual

Associate Degree is minimum requirement

Minimum of one year of experience in a laboratory or pharmaceutical/medical device/biotechnology environment or equivalent combination of related education & experience (i.e. BS w. 6 months experience).