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Aseptic Technique
- Practices used to prevent contamination while handling sterile materials.
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Autoclave
- A sterilization device that uses high-pressure, saturated steam to kill microorganisms such as bacteria, viruses, fungi, and spores.
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batch
- A specific quantity of product produced during a single, uninterrupted manufacturing cycle under uniform conditions in a closed system.
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Batch Record
- The official documentation of all steps, materials, and results for a manufacturing batch.
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Bioethics
- The study of ethical, legal, and social issues that arise in biological and medical research—for example, genetics, cloning, and stem cell use.
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Biohazard
- Any biological material that poses a threat to human, animal, or environmental health, such as viruses, human blood, bodily fluids, or contaminated sharps.
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Bioindustrial Manufacturing
- Using biological processes to create chemicals, materials, fuels, and other industrial products.
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Biomanufacturing
- Using living systems (cells, microorganisms, or enzymes) to produce products such as pharmaceuticals, biofuels, or advanced materials.
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Biomanufacturing Technician
- A manufacturing technician is responsible for carrying out assigned production operations following a defined schedule in a cGMP environment. Tasks may include monitoring bioreactors, preparing buffers, cleaning production areas, and documenting production steps accurately.
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Biopharmaceuticals (Biologics)
- Medicinal products produced in, extracted from, or semi-synthesized using biological sources such as cells or tissues.
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Bioreactor
- A vessel or system that supports biological processes—for example, growing cells or microorganisms under controlled temperature, pH, and nutrient conditions.
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Biosafety
- Practices and containment procedures used to prevent exposure to or release of potentially harmful biological agents. Laboratories follow biosafety levels (BSL-1 to BSL-4).
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Biotechnology
- The application of biological systems or organisms to develop or manufacture useful products. Biotechnology spans healthcare, agriculture, food processing, environmental management, and more.
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BSC (Biological Safety Cabinet)
- A ventilated workspace that provides filtered, sterile airflow to protect both the user and samples from contamination.
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buffer solutions
- A solution that resists changes in pH when small amounts of acid or base are added.
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Calibration
- Comparing a device’s measurement output to a known, accurate reference standard to ensure reliability.
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CAPA (Corrective and Preventive Action)
- A quality system process used to investigate, fix, and prevent issues or non-conformances.
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CDMO (Contract Development and Manufacturing Organization)
- Companies that provide services ranging from drug development to large-scale manufacturing for other organizations.
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Cell Culture
- Growing cells under controlled conditions in a lab, usually in flasks or bioreactors. Used in research, drug development, and biological production.
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cGMP
- Regulations that ensure products such as drugs and medical devices are consistently produced and controlled to high-quality standards. They cover materials, equipment, cleaning, documentation, and more.
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chromatography
- A laboratory technique used to separate, identify, and purify components of a mixture.
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Cleanroom
- A controlled environment where airborne particles, microbes, and contaminants are kept within strict limits.
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Clinical trials
- Research studies conducted with humans to evaluate medical or surgical treatments for safety, effectiveness, and side effects.
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Clinical Trials Assistant
- A Clinical Trials Assistant helps manage behind-the-scenes work for clinical studies. Responsibilities include preparing trial materials, tracking numbers, updating spreadsheets, and coordinating communication between study sites, sponsors, and contract research organizations. Good Documentation Practices (GDP) are essential—highlight any experience with organized record-keeping.
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DNA
- The molecule that carries genetic instructions for all known living organisms. Many biotech techniques involve analyzing or modifying DNA.
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Downstream Processing
- The stage after cell growth where the desired product is purified from biomass and impurities.
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Drug Discovery
- The early stage of pharmaceutical development focused on identifying promising compounds and verifying biological targets.
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EM (Environmental Monitoring)
- Measuring and testing environmental conditions—such as particle counts, air quality, or microbial contamination—in controlled areas like cleanrooms.
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FDA (Food and Drug Administration)
- The U.S. agency that regulates and monitors the safety, effectiveness, and quality of drugs, medical devices, food, and related products.
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filtration
- A separation process that removes solids, impurities, or microorganisms from a fluid using a filter medium.
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GDP (Good Documentation Practices)
- Standardized principles for creating and maintaining accurate, legible, and traceable records in regulated industries.
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Gene Therapy
- A treatment that modifies or replaces genes to cure or alleviate disease.
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Genetic Engineering
- Direct manipulation of an organism’s genome using biotechnology tools to add, remove, or alter genes.
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HPAPI
- Highly Potent Active Pharmaceutical Ingredient - compounds effective at very low doses due to high biological activity.
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ICH
- The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - creates global guidelines for drug quality, safety, and efficacy
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Immunotherapy
- A treatment that uses the immune system to fight diseases, commonly cancer.
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ISO
- The International Organization for Standardization develops global standards for industries and manufacturing.
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KPIs (Key Performance Indicator)
- Measurable values that track progress toward organizational or project goals.
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Lab Technician
- Performs technical tasks in a laboratory such as preparing samples, running tests, operating equipment, and recording data to support scientific research and experiments.
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LIMS (Laboratory Information Management System)
- Software that tracks samples, data, workflows, and compliance information.
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Metrology
- The science of measurment.
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Microbiology
- The study of microscopic organisms such as bacteria, viruses, and fungi.
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OOT (Out of Trend)
- Data that is within specification limits but deviates from expected historical patterns.
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osmometer
- An instrument that measures osmolality (the concentration of dissolved particles in a solution).
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PH Meter
- A device used to measure the acidity or alkalinity of a liquid.
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PI (Process Instructions)
- Step-by-step directions for performing a single, specific task in a manufacturing process.
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Pipetting
- Accurately measuring and transferring precise volumes of liquid using a pipette.
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Process Technician
- Supports the day-to-day manufacturing operations in a cGMP facility. They may operate equipment, follow batch records, measure and mix materials, and monitor process parameters. Attention to detail and strong GDP skills are essential.
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QA Technician
- Quality Assurance technicians ensure that products and operations meet required standards. Daily tasks include reviewing production and lab records, confirming that Standard Operating Procedures (SOPs) are followed, and assisting with audits. Any exposure to Good Manufacturing Practices (GMP) is valuable, as QA heavily focuses on documentation accuracy and compliance.
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QMS (Quality Management System)
- A formal system documenting policies, procedures, and responsibilities for maintaining quality standards and regulatory compliance.
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Quality Control
- Testing, inspecting, and verifying that a product meets its required specifications.
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Scale-Up
- The process of increasing a bioprocess from lab or pilot scale to industrial production while maintaining quality and productivity.
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SHE (Safety, Health, and Environment)
- Documentation and practices related to workplace safety, chemical handling, incident reporting, and environmental compliance.
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solution delivery systems
- Technologies and processes used to safely administer therapeutic agents and manufacture those formulations.
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SOP (Standard Operating Procedure)
- A written, step-by-step instruction document used to perform routine tasks consistently and correctly.
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Sterile Gowning
- A standardized procedure for putting on sterile protective clothing before entering controlled cleanroom environments.
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Sterilization
- A validated process that completely destroys or elimaties all form of microbial life.
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Upstream Processing
- The early stage of biomanufacturing, including cell line development, media preparation, and cultivation of cells or microorganisms.
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UV instrumentation
- Devices that use ultraviolet light to analyze, measure, or sterilize materials.
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Validation
- Documented evidence proving that a process consistently produces a product meeting predefined specifications.