BIO-LINK
DRAFT OF COMMON CORE TECHNICAL COMPETENCIES FOR
THE BIOSCIENCE LABORATORY
WHAT ARE THESE STANDARDS?
The following document is a draft of “common core” technical skill competencies that are
specific for biotechnology. Common core refers to skills and knowledge that apply broadly to
most biotechnology workplaces. Specialized skills, such as operating a flow cytometer or
performing the polymerase chain reaction, while critically important in some settings, are not
considered to be core and are not included here.
This document was created by Bio-Link and draws on the Washington State Skill Standards1
and the Department of Labor Skills Standards2, both projects that brought in large teams of
biotechnology practitioners.
These standards are intended to describe the skills and underlying knowledge required of entry
level biotechnology technicians in:
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Basic Bioscience Research/Academic Laboratories
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Testing Laboratories Relating to Biotechnology (e.g., pharmaceutical development
laboratories, quality control laboratories)
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Small Scale Biotechnology Production Facilities (e.g., facilities that produce gram
quantities of enzyme using laboratory-scale equipment)
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Bioprocessing Pilot Plants
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Large Scale Bioprocessing Facilities (Note: larger scale bioprocessing may have
additional requirements that are considered to be “core” relating to engineering and
mechanics.)
PRESENTATION AND ORGANIZATION OF THESE STANDARDS
It is not reasonable to expect entry level technicians to establish processes and procedures in a
workplace, although they may do so later in their careers or in some situations. Therefore, these
standards frequently use the phrase “according to established procedures” to indicate that the
technician is following processes and procedures that were put in place by the employer.
These standards are organized around 10 core topics:
1. Biotechnology Industry Fundamentals
2. Health, Safety, and Security
3. Basic Calculations
4. Routine Facility Support
5. Quality Control and Assurance; Basic Regulatory Affairs
6. Metrology
7. Biological Solutions
8. Basic Separation Methods
9. Assays, Data Collection, Data Evaluation
10. Cell Techniques
1. Biotechnology Industry Fundamentals: Understanding the biotechnology industry and
its interactions with society.
Critical Work Functions:
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Familiarity with the Major Application Areas of Biotechnology and their Products
Familiarity with the Life Cycle of Products (e.g., discovery in academic labs, research
and development, production)
Familiarity with Organizational Structures of Biotechnology Companies
Familiarity with the Major Technologies and Historical Development of Biotechnology
Familiarity with Legal and Ethical Issues Affecting the Application of Biotechnology
Familiarity with Information Resources Regarding Biotechnology
Familiarity with the Processes of Biotechnology and Jobs Associated with these
Processes
Awareness of the Social Impacts of Biotechnology and Ethical Issues
Technical Content Areas:
1.1 Major Application Areas
 Agriculture, Food Production, Food Processing
 Agricultural Feedstock and Chemicals
 Environmental Remediation
 Industrial Enzymes
 Drugs and Pharmaceuticals
 Medical Devices (including diagnostics) and Equipment
1.2 Major Technologies
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Laboratory Technologies
Analytical Methods
Bioprocessing
Purification Methods
Molecular Biology Methods
Bioinformatics
1.3 Business, Legal Issues, and Ethics
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Venture Capital, Angel Capital, Business Plans
Intellectual Property
 Documentation
 Patents
Confidentiality
Biomedical Ethics
Scientific Accountability
2. Health, Safety, and Security: Equipment, practices, and procedures that promote a
healthy, safe, and secure work environment.
Critical Work Functions:
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Practice Work Habits that Protect Personal Safety, Provide Safety for others in the
Laboratory, and Protect the Safety and Security of the External Environment
Apply First Aid if Required
Follow Established Emergency Procedures, if Required
Select and Use Appropriate Personal Protective Equipment at All Times
Participate in Safety and Security Training and Emergency Drills
Identify Unsafe or Insecure Conditions and Take Corrective Action According to
Established Procedures
Maintain a Sanitary and Clutter-free Work Environment
Monitor, Use, Store, and Dispose of Hazardous Materials According to Established
Procedures
Operate Autoclaves Properly
Follow Applicable Health and Safety Regulations and Institutional Procedures
Follow Applicable Security Regulations and Institutional Procedures (e.g., keep areas
locked according to company procedures, do not remove items from premises that
should not be removed)
Technical Content Areas:
2.1 Understanding Laboratory and Industrial Safety
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Electrical Hazards
Physical Hazards (e.g., glass and compressed gasses)
Chemical Hazards
Biological Hazards (e.g. understanding the nature of microbes at a basic level,
understanding that bacterial, viral, and fungal pathogens exist, understanding the
classification of biological hazards into Biological Safety Levels; understanding concepts
such as “containment,” sterilization, and disinfection)
Radiological Hazards (e.g., understanding different types of radioisotopes and their
uses; understanding the concept of half-life, understanding how radioisotopes can hamr
cells)
Aseptic Techniques to Avoid Contamination
Disinfection and Sterilization
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Use of Safety Equipment, Including But Not Limited to Personal Protective Equipment
Safety Symbols and Signs
Emergency Procedures (e.g., how to clean a small chemical spills, how to operate a fire
extinguisher)
2.2 Proper Methods of Working with Hazardous Materials
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Safe Handling and Disposal of Chemical, Biological, and Radioactive Materials
Safe Operation of Electrical Equipment
Finding and Interpreting Material Safety Data Sheets (MSDS)
Using the Information in MSDSs and Other Documents to Guide Work (e.g., using a
chemical fume hood when for chemicals that are toxic by inhalation)
Following Established Chemical Hygiene Plans
Following Universal Precautions for Biological Pathogens
Secure Use and Handling of Biological Materials
Proper Disposal of Biological Materials
Following Practices Required at Biosafety Levels 1 and 2 (working at higher levels
requires special training)
Tracking and Reporting Safety Concerns According to Established Procedures
3. Basic Calculations: Math skills required to solve basic on-the-job problems
Critical Work Functions:
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Perform Calculations Relating to Measurements
Perform Calculations Relating to Reagent And Media Formulation and Dilution
Perform Calculations Relating to Data Acquisition and Analysis
Perform Calculations Relating to Monitoring Products and Processes and Quality Control
Perform Calculations Relating to Growing Cells and Analyzing Their Growth
Perform Calculations Relating to Instrument Calibration, Maintenance, and Use
Perform Calculations Relating to Performing Assays and Procedures
Technical Content Areas:
3.1 Basic Math Techniques
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Exponents and Scientific Notation
Logarithms (e.g., converting between pH and hydrogen ion concentration)
Percents
Manipulating Algebraic Equations (e.g., converting between revolutions per minute and
relative centrifugal force in centrifugation, converting between absorbance and
transmittance in spectrophotometry)
 Solving Ratios and Proportions
3.2 Measurements
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Units of Measurement and Converting between Units
Significant Figures and Recording Data with the Correct Number of Significant Figures
Determining Accuracy and Precision in Measurements
3.3 Concentration
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Various Methods of Expressing Concentration
Reagent, Solution, and Media Formulations
Dilutions of Reagents, Media, and Solutions
Concentration and Dilution in Laboratory Procedures (e.g., calculating how to obtain a
given DNA concentration for a restriction digest)
3.4 Data Acquisition and Analysis
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Working with Linear Relationships (e.g., graphing linear relationships, understanding the
significance of an R value when provided)
 Working with Nonlinear Relationships (e.g., calculations involving radioactive decay and
half-life of isotopes)
 Graphical Methods of Analysis and Data Display (e.g., preparing and interpreting
histograms and linear plots; using Excel for preparing graphs)
 Statistical Methods for Describing Data (Descriptive statistics only, such as standard
deviation and mean)
 Statistical Methods of Process Control (e.g., interpreting and using statistical control
charts)
3.5 Cell Growth
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Growth Curves
Cell Counting, Density, and Cell Splitting
4. Routine Facility Support: Basic Functions Required to Support Operations
Critical Work Functions:
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Periodically Inventory Supplies According to Established Procedures
Anticipate Required Materials and Obtain them According to Established Procedures
Discard or Reprocess Expired Materials in Accordance with Established Procedures
Discard and Replace Broken Labware
Schedule Work Functions in an Organized Manner (e.g., conduct daily checks without
fail and document results appropriately, schedule use of shared equipment in advance)
Clean/Sterilize Glassware, Equipment, Counters, Facility According to Established
Procedures
Monitor Facility Environment (e.g., temperature) According to Established Procedures
Ensure that Equipment is Cleaned and Maintained According to Established Preventive
Maintenance Procedures
Document Facility Support Functions Using Logbooks, Computer Systems, Forms, and
Other Methods, According to Established Procedures
Technical Content Areas:
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Using Catalogues and On-line Ordering
Entering Information into Databases and Retrieving Information
Basic Safety as Described in Part 2 above.
Basic Microbiology as Relates to Avoiding Contamination
Methods of Sterilization
5. Quality Control and Assurance; Basic Regulatory Affairs: Practicing quality control
and assurance, and operating under governmental regulations.
Critical Work Functions:
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Monitor, Inspect, and Verify Quality of a Product, Procedure, Test Result, or Specimen
to Ensure Compliance with Standards and Specifications
Participate in Validation or Verification Procedures and Protocols
Control and Maintain Documentation Appropriate to Situation
Calibrate and Verify or Validate Equipment Systems; Assess Equipment Performance
Follow Established Procedures
Take and Document Corrective and Preventive Actions According to Standard Operating
Procedures or as Directed by Supervisor
Know and Comply with Applicable Current Federal, State, Local, and Industry
Regulations, as Directed by Employer
Participate in Compliance Training
Technical Content Areas:
5.1 Documentation
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Good Documentation Practices (e.g., signatures, dating, use of indelible ink, witnessing
requirements)
 Electronic Practices versus Paper Practices (e.g., nature of electronic signatures,
computer security practices)
 Types of Documents (e.g., controlled vs. uncontrolled; laboratory vs. production)
 The Roles and Uses of Various Types of Documents (e.g., batch records, SOPs,
labeling systems)
5.2 Quality Control/Quality Assurance
 Continuous Improvement Concepts
 The Technician’s Role in Audits
 Validation/Verification Testing
 Product Specifications
 Statistical Methods of Data Analysis (see 3.4 above)
 Following Standard Operating Procedures
 Proficiency Testing
5.3 Regulatory Compliance
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History of Pharmaceutical Regulations and the FDA
Organization of the FDA (e.g., the roles of CDER and CBER)
Understanding the Life Cycle of Medical Products (e.g., Discovery through clinical trials,
NDAs, INDs)
Basic Understanding of Good Laboratory Practices (GLP) and Good Manufacturing
Practices (GMP)
Awareness of Regulatory Agencies at the Local, State and Federal Levels
Adherence to Procedures Established by the Employer that Comply with Regulatory
Requirements and Standards
6. Metrology: Use measurement instrumentation properly with understanding of factors
that lead to correct results
Critical Work Functions:
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Calibrate and Maintain Measuring Instruments (e.g., balances, pH meters,
thermometers, pipettes, spectrophotometers)
Make Weight Measurements with Acceptable Accuracy and Precision (e.g., use proper
balance for each application, verify balance performance before use, monitor
temperature effects when weighing)
Make Volume Measurements with Acceptable Accuracy and Precision (e.g., use
micropipettes properly, ensure that devices are maintained according to established
procedures, avoid contamination of samples, select glassware properly)
Make pH Measurements with Acceptable Accuracy and Precision (e.g., calibrate
instrument properly, verify instrument performance before use, select proper electrodes
for a given application, compensate for temperature effects on pH)
Make Temperature Measurements with Acceptable Accuracy and Precision (e.g., select
proper device for application, verify performance of device before use)
Make Spectrophotometric Measurements with Acceptable Accuracy and Precision (e.g.,
ensure that instrument has been maintained according to established procedures)
Technical Content Areas:
6.1 General Principles of Metrology
 National/International Standards, Calibration, and Traceability
 Methods of Calibration and Performance Verification
 Recording Values with Correct Significant Figures
 Accuracy, Evaluating Accuracy (e.g., by calculating percent error)
 Precision, Evaluating Precision (e.g., by calculating standard deviation)
 Types and Causes of Measurement Error
 Uncertainty in Measurement (basics)
 Preventive Maintenance Programs
6.2 Specific Measuring Methods
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Weighing
Measuring Volume
Measuring Temperature
Measuring pH
Measuring Light Absorbance
7. Biological Solutions: Be able to prepare, store, and handle reagents, solutions, and
media to support biological systems
Critical Work Functions:
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Perform Calculations Necessary to Prepare Reagents to Particular Concentrations
Order, Verify, Store, Obtain, and Handle Raw Materials According to Established
Procedures
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Discard Outdated Materials According to Established Procedures
Prepare or Obtain Water of Verified Suitability for Application
Wash/Prepare or Obtain Glassware, Pipettes, and Other Devices of Suitable Quality for
Application According to Established Procedures
Verify Suitability of Required Measuring Instruments (e.g., calibrated balance)
According to Established Procedures
Weigh and Measure Raw Materials and Water (or Other Solvent) with Suitable Accuracy
and Precision According to Established Procedures
Mix Reagents, Solutions, and Media Properly According to Established Procedures
Sterilize Reagents, Solutions, and Media Properly, When Necessary, According to
Established Procedures
Set Expiration Dates Appropriately, When Necessary, According to Established
Procedures
Verify that Reagents, Solutions, and Media were Made Correctly According to
Established Procedures
Label Reagents, Solutions, and Media Properly According to Established Procedures
Store Reagents, Solutions, and Media Under Proper Conditions According to
Established Procedures
Follow Appropriate Documents According to Established Procedures
Document Work According to Established Procedures
Technical Content Areas:
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Calculations Relating to Concentration
Verification Methods for Measuring Instrument Performance
Measuring Instrument Operation; Avoiding Errors
Use of Mixing Devices
Methods of Sterilization and When Each is Used
Methods to Verify Successful Sterilization
Operation of Sterilization Instruments (e.g., autoclaves, filtration devices)
Methods of Assessing the Quality of Solutions, Reagents, and Media (e.g., checks of
conductivity or osmolarity, sterility checks)
Storage Methods for Solutions and Media
Basic Chemistry of Buffers and pH
8. Basic Separation Methods: Be able to use centrifuges, filtration systems, and
electrophoresis devices that are appropriate for a given application in a safe and
effective manner.
Critical Work Functions:
Follow established procedures to:
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Operate Centrifuges
Use Filtration Devices and Systems
Use Electrophoresis Systems
Technical Content Areas:
9.1 Centrifugation
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Selection, Purchase, Use of Centrifuge Rotors, Bottles, Tubes, and Adaptors that are
Appropriate for Specific Applications
 Centrifuge/rotor Safety Concerns
 Proper Operation of Centrifuge
 Maintenance Requirements for Centrifuges and Rotors
9.2 Filtration
 Selection, Purchase, Use of Filtration Devices Appropriate for Specific Applications
 Maintenance and Operation of Filtration Systems
9.3 Electrophoresis
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Preparation or Obtaining of Gels for Electrophoresis (e.g., prepare agarose gels)
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Set-Up and Conduct Electrophoretic Separations Efficiently and Safely
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Proper Controls and Standards (e.g., use of molecular weight markers, known
standards)
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Isolate, Identify, and Prepare Samples
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Prepare Documentation Associated with Samples
Document Electrophoresis Procedures and Results
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Evaluate Results of Separations
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Report Results in Written Technical Reports and Orally
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Recognize, Report, and Trouble-shoot Problems with Separations with Assistance of
Supervisor and According to Established Procedures (e.g., follow CAPA policy, if
present)
9. Assays, Data Collection, Data Evaluation: Perform tests on samples to provide
information about those samples; properly document, store, and evaluate results.
Critical Work Functions:
Follow established procedures to:
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Set-Up and Conduct Tests/Assays According to Established Procedures: Chemical,
Biological, Clinical, Environmental, Robotic, or Mechanical
Proper Controls and Standards (e.g., negative, no template, controls in PCR)
Isolate, Identify, and Prepare Sample/Specimens for Assays
Prepare Documentation Associated with Samples and “Chain of Custody”
Document Assay Procedures and Results
Evaluate Results of Assays (e.g., determine amount of analyte in quantitative assay)
Report Results in Written Technical Reports and Orally (e.g., proper report format is
used, all resources are properly referenced, graphs and tables are clearly labeled and
explained, data is properly analyzed)
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Recognize, Report, and Trouble-shoot Problems with Assays with Assistance of
Supervisor and According to Established Procedures (e.g., follow CAPA policy, if
present)
Technical Content Areas:
9.1 Lab Skills
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Positive and Negative Controls for Assays
Use of Standards in Assays
Sample Preparation, Storage, and Handling Methods
Chain of Custody Requirements for Samples
Following Standard Assay Procedures (e.g., those in laboratory manuals,
manufacturer’s instructions)
Preparation of Assay Reagents (see part 7, above)
Operation of Instruments Associated with Assays (e.g., spectrophotometers)
Verification that Instruments have Been Maintained According to their Maintenance Plan
Use of Laboratory Notebooks Properly (or Appropriate Forms) for Documentation
Methods of Data Analysis and Summary (see # xx above)
Proper Labeling Techniques for Samples and Standards
Methods of Verifying that an Assay is Performing Properly
Use of Reference Standards, Standard Curves
10. Cell Techniques: Be able to visualize cells using basic microscopic techniques, grow
cells aseptically, count cells, harvest cells.
Critical Work Functions:
Follow established procedures to:
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Order, Verify, Store, Obtain, and Handle Raw Materials According to Procedures
Discard Outdated Materials According to Procedures
Clean and/or sterilize laboratory and supplies
Monitor Cell Growth and Health
Maintain Suitable Environmental Conditions for Cell Growth
Feed, Passage/Transfer Cells
Prepare cultures for storage (e.g., put on proper media or freeze)
Thaw or begin fresh cultures from stocks
Monitor Gauges And Recording Instruments To Ensure That Specified Conditions Are
Maintained
Participate in the Installation, Modification, and Upgrade of Equipment
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Maintain the Equipment and Control Systems Used for Cells
Perform Documentation
Technical Content Areas:
10.1 Cell Biology
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Understand Basic Prokaryotic and Eukaryotic Cell Structure and Function (e.g., know
structures and functions of organelles, know key differences between prokaryotic and
eukaryotic cells.)
 Understand Uses of Cells in Biotechnology (e.g., uses of cells in cancer research, cells
as “factories to produce enzymes and drugs, cells used for regenerative medicine
therapies)
10.2 Biological Safety
See Part 2.2, above
10.3 Laboratory Methods
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Microscopy Techniques
Cell Counting Techniques
Cell Maintenance, Feeding, Transferring
Calculations Relating to Cell Growth, Density, and Splitting
Cell Morphology and Health
Aseptic Techniques
Obtaining, Weighing, Measuring, and Checking Raw Materials, Preparing Growth Media
for Prokaryotic and Eukaryotic Cells
Setting up Equipment for Growing Cells; Monitoring Equipment
Sterilization of Equipment and Reagents
Safety and Security of Biological Materials
PRIMARY REFERENCES
1. 2007 Biotechnology and Biomedical Skill Standards; Copyright 2007, State of Washington
through the State Board for Community and Technical Colleges.
2. Bioscience Competency Model; United States Department of Labor.
http://www.careeronestop.org/COMPETENCYMODEL/pyramid.aspx?BIOSCI=Y