DRAFT May 13, 2013
1
WHAT ARE THESE STANDARDS?
The following document is a draft of “common core” technical skill standards 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.
This document 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 ability to perform tasks and the underlying knowledge
required of entry level biotechnology technicians in:

Basic Bioscience Research/Academic Laboratories

Testing Laboratories Relating to Biotechnology (e.g., pharmaceutical development laboratories,
quality control laboratories)

Small Scale Biotechnology Production Facilities (e.g., facilities that produce gram quantities of
enzyme using laboratory-scale equipment)

Bioprocessing Pilot Plants

Large Scale Bioprocessing Facilities (Note: larger scale bioprocessing may have additional
requirements that are considered to be “core” relating to engineering and mechanics.)
NOTES RELATING TO THE PRESENTATION AND ORGANIZATION OF THIS
DOCUMENT
2

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.

The term “common work tasks” relates to things an entry level technician might do. These are
items that might be assessed in a laboratory setting.

The term “underlying technical understanding” is used to indicate underlying knowledge
required to perform common tasks at an entry level. At a later time, assessments will be
developed that more fully articulate the level of understanding required; these assessments can be
written “paper and pencil” format.

The first topic, “Biotechnology Industry Fundamentals,” is different from the other nine topics in
that it is not tied to any “Common Work Tasks,” i.e. things that entry level workers do. Rather
this topic summarizes common knowledge related to the biotechnology industry.
These standards in this document are organized around 10 core topics:
3
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.
Underlying Technical Understanding:
1.1 Historical Development of Biotechnology
1.2 Major Application Areas
 Agriculture, Food Production, Food Processing
 Agricultural Feedstock and Chemicals
 Environmental Remediation
 Biofuels
 Industrial Enzymes
 Drugs and Pharmaceuticals
 Regenerative Medicine
 Medical Devices (including diagnostics) and Equipment
1.3 Major Technologies
 Laboratory Technologies
 Analytical Methods
 Bioprocessing
 Purification Methods
 Molecular Biology Methods
 Bioinformatics
1.4 Business, Legal Issues
 Organizational Structures of Biotechnology Companies
 Life Cycle of Products (e.g., discovery in academic labs, research and development,
production)
 Venture Capital, Angel Capital, Business Plans
 Intellectual Property
 Documentation
 Patents
 Confidentiality
 Biomedical Ethics
 Scientific Accountability
 Regulatory Agencies and Regulations
1.5 Information Resources
 Scientific Literature
 Internet Resources
 Networking and Social Resources
1.6 Societal and Ethical Issues
 Biomedical Ethics
 Animal Research
 Genetically Modified Foods
4
2. Health, Safety, and Security: Equipment, practices, and procedures that promote a
healthy, safe, and secure work environment.
Common Work Tasks:

















Maintain a Sanitary and Clutter-free Work Environment
Monitor, Use, Store, and Dispose of Hazardous Materials According to Established
Procedures
Find and Use Material Safety Data Sheets and Other Information Sources (e.g., find out
that a chemical is toxic by inhalation and use a chemical fume hood when working with
it)
Follow Applicable Health and Safety Regulations and Institutional Procedures Including
but Not Limited to Chemical Hygiene Plan
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)
Follow Universal Precautions for Biological Pathogens
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
Follow Institutional Policies Relating to Biological Hazards
Apply Standard Aseptic Technique when Appropriate
Use Disinfection and Sterilization Techniques as Appropriate
Work safely with organisms identified as requiring BSL1 or BSL2 practices
Work safely with Radioisotopes Commonly Used in Laboratory Settings
Identify Unsafe or Unsecure Conditions and Take Corrective Action According to
Established Procedures
Track Safety Concerns According to Established Procedures
Underlying Technical Understanding:









5
The Nature of Electricity, Electrical Hazards, and General Precautions Required to Safely
Operate Electrical Devices
The Types of Physical Hazards in Laboratories (e.g., glass and compressed gasses)
Chemical Hazards (e.g., chemistry sufficient to understand storage methods that prevent
chemical interactions)
Biological Hazards (e.g. sufficient microbiology to distinguish bacterial, viral, and fungal
pathogens and to understand the classification of biological hazards into Biological Safety
Levels. Vocabulary 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 harm cells)
Contamination (e.g., the risks of contamination, cross-contamination, chemical
contaminations, contamination by microorganisms)
Avoiding Contamination (e.g., aseptic technique, the purpose of disinfectants)
Disinfection and Sterilization (e.g., understanding how steam sterilization and chemical
disinfectants work and situations in which different methods are used)
Purpose and Proper Use of Safety Equipment (the purpose of various types of PPE)



Meaning of Safety Symbols and Signs
Emergency Procedures (e.g., how to clean a small chemical spills, how to operate a fire
extinguisher)
Sources of Safety Information (e.g., institutional manuals, MSDSs, internet resources)
3. Basic Calculations: Math skills required to solve basic on-the-job problems
Common Work Tasks:














Perform Calculations Relating to Measurements
Perform Calculations Relating to Reagents, Solutions, and Media Formulations
Perform Calculations Relating to Dilution of Liquids
Perform Calculations Embedded in Laboratory Procedures (e.g., calculate how to obtain a
given DNA concentration for a restriction digest)
Perform Calculations Relating to Data Acquisition and Analysis
Graph and Display Data Using Excel and Other Computer Tools
Graph and Display Data by Hand
Graph and Display Linear Relationships
Prepare Histograms
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
Perform Calculations Relating to Cell Counting, Density, and Cell Splitting
Underlying Technical Understanding:
3.1 Basic Math Techniques
 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
 Units of Measurement and Converting between Units
 Significant Figures and Recording Data with the Correct Number of Significant Figures
 The Meaning of Accuracy, Precision, Error, Standards
3.3 Concentration
 Various Methods of Expressing Concentration
 The Nature of Reagents, Solutions, and Media Formulations
 What it Means to Dilute of Reagents, Media, and Solutions
 The Application of Ratios and Proportions to Laboratory Solutions
 The Use of “Dimensional Analysis” as a tool for Solving Conversion Problems
6





Working with Linear Relationships (e.g., understanding linear relationships,
understanding the significance of an R value when provided)
Working with Nonlinear Relationships (e.g., radioactive decay and half-life of isotopes)
Graphical Methods of Analysis and Data Display (e.g., interpreting histograms and linear
plots)
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
 Growth Curves (e.g., understanding the nature of population growth, exponential growth,
stationary phase)
4. Routine Facility Support: Basic Functions Required to Support Operations
Common Work Tasks:
 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
 Participate in the Installation, Modification, and Upgrade of Equipment
 Enter Information into Databases and Retrieve Information
 Document Facility Support Functions Using Logbooks, Computer Systems, Forms, and
Other Methods, According to Established Procedures
Underlying Technical Understanding:
 Sources of Materials; On-line Ordering
 Basic Safety as Described Previously
 Basic Microbiology as Described Previously
 Methods of Sterilization as Described Previously
5. Quality Control and Assurance; Basic Regulatory Affairs: Practicing quality control and
assurance, and operating under governmental regulations.
Common Work Tasks:
 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 Proper Documentation
 Calibrate and Verify or Validate Equipment Systems; Assess Equipment Performance
 Follow Established Procedures
 Take and Document Corrective and Preventive Actions According to Standard Operating
7



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
Participate in Proficiency Testing
Underlying Technical Understanding:
5.1 Documentation
 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)
5.2 Quality Control/Quality Assurance
 Continuous Improvement Concepts
 The Technician’s Role in Audits
 Purpose of Validation/Verification Testing
 Nature of Product Specifications
 Statistical Methods of Data Analysis as Described Previously
5.3 Regulatory Compliance
 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 and Good Manufacturing Practices
 Awareness of Regulatory Agencies at the Local, State and Federal Levels
6. Metrology: Use measurement instrumentation properly with understanding of factors
that lead to correct results
Common Work Tasks:
 Calibrate and Maintain Measuring Instruments (e.g., balances, pH meters, thermometers,
pipettes, spectrophotometers)
 Verify Proper Performance of Instruments
 Use Significant Figures Correctly When Recording Measurement Values
 Evaluate Accuracy (e.g., by calculating percent error)
 Evaluate Precision (e.g., by calculating standard deviation)
 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
8


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)
Underlying Technical Understanding:
6.1 General Principles of Metrology
 National/International Standards, Calibration, and Traceability
 Common Terminology (e.g., accuracy, precision, error)
 General Methods of Calibration and Performance Verification
 Significant Figures as an Expression of Uncertainty
 Types and Causes of Measurement Error
 Uncertainty in Measurement (basics)
 Preventive Maintenance Programs
6.2 Understand Sources of Error in Specific Measuring Methods
 Weighing (e.g., understand effect of temperature on weighing accuracy and precision)
 Measuring Volume (e.g., understand micropipettes, proper operation, preventing damage
to them)
 Measuring Temperature
 Measuring pH (e.g., know how to detect values that are not accurate or precise,
understand trouble-shooting methods, understand that there are different types of
electrodes for certain applications)
 Measuring Light Absorbance (e.g., understand the basic principles of spectrophotometry
and how instruments function)
7. Biological Solutions: Be able to prepare, store, and handle reagents, solutions, and media
to support biological systems
Common Work Tasks:
 Perform Calculations Necessary to Prepare Reagents to Particular Concentrations
 Order, Verify, Store, Obtain, and Handle Raw Materials According to Established
Procedures
 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
9



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
Underlying Technical Understanding:
 Calculations Relating to Concentration as Previously Described
 Verification Methods for Measuring Instrument Performance as Previously Described
 Use of Mixing Devices and Selection of Proper Mixing Device for an Application
 Methods of Reagent Sterilization and When Each is Used
 Methods to Verify Successful Sterilization
 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.
Common Work Tasks:
Follow established procedures to:
 Operate and Maintain Centrifuges Safely
 Select, Purchase, Use Centrifuge Rotors, Bottles, Tubes, and Adaptors that are
Appropriate for Specific Applications
 Select Proper Filtration System for an Application
 Purchase, Use, and Maintain Filtration Devices and Systems
 Prepare or Obtain Gels for Electrophoresis (e.g., prepare agarose gels)
 Set-Up and Conduct Electrophoretic Separations Efficiently and Safely
 Use Proper Controls and Standards During Electrophoretic Separation (e.g., use of
molecular weight markers, known standards)
 Isolate, Identify, and Prepare Samples for Separations
 Maintain Documentation Associated with Samples
 Maintain Documentation Associated with Results
 Evaluate Results of Separations
 Recognize, Report, and Trouble-shoot Problems with Separations with Assistance of
Supervisor and According to Established Procedures
Underlying Technical Understanding:
9.1 General Separation Principles
 Selecting Proper Separation Method (e.g., knowing that filters are used for sterilizing
antibiotics)
 Separation Strategies (e.g., understanding how more than one method might be used
sequentially in a strategy to purify a protein)
 Sample Preparation Methods (understand importance of preparing samples properly and
protecting from damage)
9.1 Centrifugation
 Understand Centrifuge/Rotor Safety Concerns
 Understand Maintenance Requirements for Centrifuges and Rotors
10
9.2 Filtration
 Selection, Purchase, Use of Filtration Devices Appropriate for Specific Applications; Use
of Catalogues
9.3 Electrophoresis
 Ohm’s Law and Principles of Electrophoresis
 Safety Concerns
9. Assays, Data Collection, Data Evaluation: Perform tests on samples to provide
information about those samples; properly document, store, and evaluate results.
Common Work Tasks:
Follow established procedures to:












Set-Up and Conduct Tests/Assays According to Established Procedures: Chemical,
Biological, Clinical, Environmental, Robotic, or Mechanical
Use Proper Controls and Standards
Obtain Samples for Assays
Prepare Documentation Associated with Samples
Label Samples Properly
Prepare Samples for Analysis According to Written Procedures
Store Samples Properly According to Established Procedures
Use Instruments that Analyze Samples Properly; Verify Proper Maintenance and
Performance of Instruments
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)
Recognize, Report, and Trouble-shoot Problems with Assays with Assistance of
Supervisor and According to Established Procedures (e.g., follow CAPA policy, if
present)
Underlying Technical Understanding:
9.1 Lab Skills
 Importance and Purpose of Positive and Negative Controls for Assays
 Use of Standards in Assays
 Importance of Proper Sample Preparation, Storage, and Handling Methods
 Chain of Custody Requirements for Samples
 Understand How to Follow Assay Procedures (e.g., those in laboratory manuals,
manufacturer’s instructions)
 Understand Proper Operation, Maintenance, and Performance Verification of Instruments
Associated with Assays (e.g., spectrophotometers as previously described)
 Understand Documentation Associated with Assay Results
 Understand Methods of Data Analysis for Assay Results
 Understand Use of Reference Standards, Standard Curves
11
10. Cell Techniques: Be able to visualize cells using basic microscopic techniques, grow cells
aseptically, count cells, harvest cells.
Common Work Tasks:
Follow established procedures to:

















Order, Verify, Store, Obtain, and Handle Raw Materials According to Procedures
Discard Outdated Materials According to Procedures
Clean and/or Sterilize Laboratory Equipment and Supplies
Monitor Cell Growth and Health
Maintain Suitable Environmental Conditions for Cell Growth (e.g., use sterile technique,
maintain incubators)
Prepare Culture Media According to Established Procedures
Feed, Passage/Transfer Cells
Perform Calculations Relating to Cell Splitting
Evaluate General Health of Cells Based on Morphology and Appearance of Medium
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
Maintain the Equipment and Control Systems Used for Cells
Use Microscopes to Visualize and Cells
Use Hemacytometers to Count Cells
Perform Documentation
Use Appropriate Safety Precautions (e.g., apply BSL1 or BSL2 techniques)
Underlying Technical Understanding:
10.1 Cell Biology
 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)
 Understand Terminology (e.g., cell line, tissue culture, cell culture)
 Understand Contamination as Described Previously
 Understand Principles of Biological Safety as Previously Described
10.2 Biological Safety as Described Previously
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
12