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Biochemist 1, Scientific Operations_PR
Calle Vicks Cayey, PR 00736 US
Posted: 01/02/2025
2025-01-02
2025-02-17
Job Number: 261327
Job Description
Position: Biochemist I
Pay Rate: $16.00 p/h.
JOB SUMMARY
Perform manufacturing activities in areas such as: purification, formulation, tissue culture or conjugation. Responsible for following established instructions for the execution of manufacturing production orders. Performs assays and tests following standard protocols. Provides cleaning, inspection, verification for calibration, troubleshooting and maintenance of equipment when needed. Participates in continuous improvement projects and initiatives. Ensures that work performed conforms to QSR, ISO and OSHA standards and regulations.
DUTIES AND RESPONSIBILITIES
• TC Area Responsibilities
• Creates, maintains, and tests Master and Working cells Banks of antibody producing hybridomas.
• Conducts in-process tests for viability, secretion and sterility.
• Processes cell supernatant to remove debris and to concentrate product before purification, monitoring cell culturing process by various biochemical and immunologic procedures.
• Formulates purifies according finish goods specifications for concentration following dilution batch records.
• Purification Area Responsibilities
• Perform incoming testing for Culture Media, ascites fluids and materials that request evaluation using available purification techniques.
• Test and purifies monoclonal antibodies from serum/ascites fluid and tissue culture supernatant by appropriate serum fractionation and/or column chromatographic techniques, and formulates monoclonal antibodies reagents.
• Formulates purifies according finish goods specifications for concentration following dilution batch records.
• Performs resin retest and reclaim process.
• Conjugation Area Responsibilities
• Conjugates monoclonal antibodies from purified material using required molecules Fluorophore or dye of the molecules, monitoring conjugation process at several stages to maximize yield and quality of conjugated antibodies.
• Conjugates according finish goods specifications for concentration following dilution batch records.
• Prepares malemaide and raw materials based on production plan requirements.
• Maintains chromatography systems in order, including column packaging cleaning and equilibrations and report any breakdowns.
• General Responsibilities
• Provides in-process testing as required.
• Completes materials movement transactions on SAP system and performs the required inventory control activities to maintain accuracy.
• Maintains detailed production records.
• Generates Quality Reports such as Out of Specification Reports, Deviations Reports, etc.
• Initiates and participates in investigations following established quality assurance procedures and approved protocols, instructions etc.
• Performs cleaning, inspection, verification for calibration and maintenance of equipment. Maintains related logs and records. Performs equipment troubleshooting.
• Participates in the development and revision of Standard Operating Procedures (SOPs).
• Participates in project related tasks as required.
• Promotes a safe work environment. Provides recommendations on maintaining the safety of the work environment. Follows safety procedures. Participates in Environment Health and Safety (EH&S) programs. Initiates a corrective action whenever a hazard is identified.
Notifies supervisor of all observed hazardous conditions or unsafe work practices.
• Keeps abreast of the basic requirements for compliance in own area of work and complies with those requirements. Participates as required in training on regulatory issues affecting own area of work. Brings regulatory compliance questions/issues to next level of
management.
• Actively participate in the Daily Management System by attending, leading shift start up meetings, and providing appropriate metrics
• Participates in Continuous Improvement Projects related tasks as required.
• Provide recommendations to support systems that continuously improve product/process quality and product availability, reduce cost, and increase production capability.
• Maintain good housekeeping practices.
• Performs other related duties and assignments as required.
• Participates of Knowledge Transfer activities as required.
MINIMUM QUALIFICATIONS
KNOWLEDGE AND SKILLS
• Knowledge of methods required to create, maintain and test Master and Working Cell Banks of antibody hybridomas.
• Knowledge of the operation of related instrumentation such as Micropipettes and volumetric devices, Microscopes, Micro plate reader, CO2 Incubators, centrifuges and pipette and Biosafety Hoods.
• Knowledge in the purification of monoclonal antibodies from serum/ascites fluid and tissue culture supernatant by appropriate serum fractionation and/or column chromatographic techniques.
• Basic knowledge in chemicals and kinetic reactions.
• FPLC (Fast Protein Liquid Chromatography), HPLC (High Pressure liquid Chromatography), UV monitors, chart recorders, electrophoresis and size exclusion columns knowledge preferable.
• Knowledge in the formulation of reagents.
• Knowledge of the operation of related instrumentation such Spectrophotometry and Centrifuges.
• Knowledge of GMP, FDA, ISO and OSHA requirements highly desirable.
• Knowledge of SAP highly desirable.
• Working knowledge of MS Windows environment software such as MS Office.
• Effective skills using analytical thinking, problem solving, interpersonal relationships, written and oral communication, and planning/organization.
• Demonstrated ability to follow established policies and procedures.
• Fully Bilingual (English and Spanish).
• Willing to travel to US mainland and offshore.
EDUCATION AND EXPERIENCE
Requires a Bachelors Degree in a related scientific discipline (such as Chemistry, Biochemistry, Biology, Microbiology or Engineering) and a minimum of one year of experience in a laboratory or pharmaceutical/medical device/biotechnology environment or equivalent combination of related education and experience.
MENTAL DEMAND
Apply commonsense understanding to carry out detailed written or oral instructions. Manage stressful situations.
PHYSICAL DEMAND
Occasionally, the work requires carrying, lifting, pushing and pulling of heavy weight level of objects. In addition, occasionally requires standing. Frequently, the job requires walking, sitting, reaching, handling, fingering, talking, hearing, seeing (near/far) vision, visual color discrimination and seeing (depth perception).
WORKING ENVIRONMENT
The work is performed constantly inside the building. The work requires exposure to wet and/or humid conditions. Also, the work environment has noise (vibration), hazards exposures (electrical, burns and biomedical) and atmospheric conditions (fumes and odors).
Pay Rate: $16.00 p/h.
JOB SUMMARY
Perform manufacturing activities in areas such as: purification, formulation, tissue culture or conjugation. Responsible for following established instructions for the execution of manufacturing production orders. Performs assays and tests following standard protocols. Provides cleaning, inspection, verification for calibration, troubleshooting and maintenance of equipment when needed. Participates in continuous improvement projects and initiatives. Ensures that work performed conforms to QSR, ISO and OSHA standards and regulations.
DUTIES AND RESPONSIBILITIES
• TC Area Responsibilities
• Creates, maintains, and tests Master and Working cells Banks of antibody producing hybridomas.
• Conducts in-process tests for viability, secretion and sterility.
• Processes cell supernatant to remove debris and to concentrate product before purification, monitoring cell culturing process by various biochemical and immunologic procedures.
• Formulates purifies according finish goods specifications for concentration following dilution batch records.
• Purification Area Responsibilities
• Perform incoming testing for Culture Media, ascites fluids and materials that request evaluation using available purification techniques.
• Test and purifies monoclonal antibodies from serum/ascites fluid and tissue culture supernatant by appropriate serum fractionation and/or column chromatographic techniques, and formulates monoclonal antibodies reagents.
• Formulates purifies according finish goods specifications for concentration following dilution batch records.
• Performs resin retest and reclaim process.
• Conjugation Area Responsibilities
• Conjugates monoclonal antibodies from purified material using required molecules Fluorophore or dye of the molecules, monitoring conjugation process at several stages to maximize yield and quality of conjugated antibodies.
• Conjugates according finish goods specifications for concentration following dilution batch records.
• Prepares malemaide and raw materials based on production plan requirements.
• Maintains chromatography systems in order, including column packaging cleaning and equilibrations and report any breakdowns.
• General Responsibilities
• Provides in-process testing as required.
• Completes materials movement transactions on SAP system and performs the required inventory control activities to maintain accuracy.
• Maintains detailed production records.
• Generates Quality Reports such as Out of Specification Reports, Deviations Reports, etc.
• Initiates and participates in investigations following established quality assurance procedures and approved protocols, instructions etc.
• Performs cleaning, inspection, verification for calibration and maintenance of equipment. Maintains related logs and records. Performs equipment troubleshooting.
• Participates in the development and revision of Standard Operating Procedures (SOPs).
• Participates in project related tasks as required.
• Promotes a safe work environment. Provides recommendations on maintaining the safety of the work environment. Follows safety procedures. Participates in Environment Health and Safety (EH&S) programs. Initiates a corrective action whenever a hazard is identified.
Notifies supervisor of all observed hazardous conditions or unsafe work practices.
• Keeps abreast of the basic requirements for compliance in own area of work and complies with those requirements. Participates as required in training on regulatory issues affecting own area of work. Brings regulatory compliance questions/issues to next level of
management.
• Actively participate in the Daily Management System by attending, leading shift start up meetings, and providing appropriate metrics
• Participates in Continuous Improvement Projects related tasks as required.
• Provide recommendations to support systems that continuously improve product/process quality and product availability, reduce cost, and increase production capability.
• Maintain good housekeeping practices.
• Performs other related duties and assignments as required.
• Participates of Knowledge Transfer activities as required.
MINIMUM QUALIFICATIONS
KNOWLEDGE AND SKILLS
• Knowledge of methods required to create, maintain and test Master and Working Cell Banks of antibody hybridomas.
• Knowledge of the operation of related instrumentation such as Micropipettes and volumetric devices, Microscopes, Micro plate reader, CO2 Incubators, centrifuges and pipette and Biosafety Hoods.
• Knowledge in the purification of monoclonal antibodies from serum/ascites fluid and tissue culture supernatant by appropriate serum fractionation and/or column chromatographic techniques.
• Basic knowledge in chemicals and kinetic reactions.
• FPLC (Fast Protein Liquid Chromatography), HPLC (High Pressure liquid Chromatography), UV monitors, chart recorders, electrophoresis and size exclusion columns knowledge preferable.
• Knowledge in the formulation of reagents.
• Knowledge of the operation of related instrumentation such Spectrophotometry and Centrifuges.
• Knowledge of GMP, FDA, ISO and OSHA requirements highly desirable.
• Knowledge of SAP highly desirable.
• Working knowledge of MS Windows environment software such as MS Office.
• Effective skills using analytical thinking, problem solving, interpersonal relationships, written and oral communication, and planning/organization.
• Demonstrated ability to follow established policies and procedures.
• Fully Bilingual (English and Spanish).
• Willing to travel to US mainland and offshore.
EDUCATION AND EXPERIENCE
Requires a Bachelors Degree in a related scientific discipline (such as Chemistry, Biochemistry, Biology, Microbiology or Engineering) and a minimum of one year of experience in a laboratory or pharmaceutical/medical device/biotechnology environment or equivalent combination of related education and experience.
MENTAL DEMAND
Apply commonsense understanding to carry out detailed written or oral instructions. Manage stressful situations.
PHYSICAL DEMAND
Occasionally, the work requires carrying, lifting, pushing and pulling of heavy weight level of objects. In addition, occasionally requires standing. Frequently, the job requires walking, sitting, reaching, handling, fingering, talking, hearing, seeing (near/far) vision, visual color discrimination and seeing (depth perception).
WORKING ENVIRONMENT
The work is performed constantly inside the building. The work requires exposure to wet and/or humid conditions. Also, the work environment has noise (vibration), hazards exposures (electrical, burns and biomedical) and atmospheric conditions (fumes and odors).
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