Reply to comment

• 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

• 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

• Laboratory Technologies
• Analytical Methods
• Bioprocessing
• Purification Methods
• Molecular Biology Methods
• Bioinformatics

1.3 Business, Legal Issues, and Ethics

• Venture Capital, Angel Capital, Business Plans
• Intellectual Property

• Documentation

• Patents

• Confidentiality
• Biomedical Ethics
• Scientific Accountability

• 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)

• 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
• 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

• 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

• 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

• 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
• Determining Accuracy and Precision in Measurements

3.3 Concentration

• 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

• 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

• Growth Curves
• Cell Counting, Density, and Cell Splitting

• 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

• 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

• 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

• 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

• 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

• 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)

• 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

• Weighing
• Measuring Volume
• Measuring Temperature
• Measuring pH
• Measuring Light Absorbance

• 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
• 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

• 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

• Operate Centrifuges
• Use Filtration Devices and Systems
• Use Electrophoresis Systems

• 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

• Preparation or Obtaining of Gels for Electrophoresis (e.g., prepare agarose gels)

• Set-Up and Conduct Electrophoretic Separations Efficiently and Safely
• Proper Controls and Standards (e.g., use of molecular weight markers, known standards)
• Isolate, Identify, and Prepare Samples
• Prepare Documentation Associated with Samples
• Document Electrophoresis Procedures and Results
• Evaluate Results of Separations
• Report Results in Written Technical Reports and Orally
• Recognize, Report, and Trouble-shoot Problems with Separations with Assistance of Supervisor and According to Established Procedures (e.g.,  follow CAPA policy, if present)

• 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)
• Recognize, Report, and Trouble-shoot Problems with Assays with Assistance of Supervisor and According to Established Procedures (e.g.,  follow CAPA policy, if present)

• 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

• 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
• Maintain the Equipment and Control Systems Used for Cells
• Perform Documentation

• 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

• 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