Biotechnology Knowledge Skills

Be able to demonstrate knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell culture products

cGMP stands for current Good Manufacturing Practices. GMPs apply to industries that produce pharmaceuticals, food, and beverages. The FDA publishes guidances to help companies understand how they view the regulations related to drug manufacturing. Since FDA's thinking evolves, it is important to ...

Understand how mixtures are separated through chromatographic techniques such as thin layer and gas chromatography

Understand and comply with the procedures and systems needed to comply with company standards.

Know how to collect information, analyze information, identify and investigate product and quality problems, and take appropriate and effective corrective and/or preventive action to prevent their recurrence.

Provide immediate and proactive support to customers.

Ensure that manufacturing data is maintained, reviewed, analyzed, assessed, ensuring accuracy and compliance

Be able to repair small electronics. Understand current, voltage, and power.

Know what to do when there is an emergency. This would include CPR and basic first aid.

Understand and comply with environmental health and safety rules to prevent injuries, protect the environment, and prevent pollution.

Follow Good Clinical Practices in working with patients and protecting human subjects.

Companies that conduct pre-clinical research must comply with Good Laboratory Practices. In a company, GLPs are part of a quality system that covers the process and conditions under which non-clinical laboratory studies are planned, performed, monitored, recorded, reported, and archived.

Companies that manufacture substances regulated by the FDA must adhere to Good Manufacturing Practices (GMPs). Good Documentation Practices (GDP) are important in recording and managing data related to test results.

Know how to assess food safety by the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product.

Understand how to find MSDS information and instructions for handling and disposing of hazardous materials

The International Council on Harmonization Good Clinical Practice guidelines (ICH-GCP) cover quailty, efficacy, safety, and cross-cutting topics. The International Council on Harmonization (ICH) is a non-profit group that works to ensure that safe, effective, and high quality medicines are developed ...

Review, document, maintain, and order laboratory supplies. Record information.

Understand the purpose of a LIMS and be able to use one.

Know how to find MSDS information and follow proper laboratory safety protocols

Understand the steps involved in manufacturing and delivering a product that meets the required specifications.

Know how to culture, identify, and enumerate microbes. Microbiologists must be able to isolate and obtain pure cultures of bacteria and other microbes. They must also be able to identify sources of microbial contamination and know how to use sterilization and filtration to control microbial growth.

Understand molecular biology techniques, when and why they are used and what they measure.

Understand project timelines, start-up and changeover schedules

Understand how chromatography is used' for purifying proteins, including gel filtration, ion exchange, and affinity chromatography

Understand quality systems and documentation

Understand the meaning of a quality system and how a company's practices are used to maintain quality.

Demonstrate knowledge of regulatory agencies governing the manufacture and distribution of biotechnology-derived products

Know how to find information, design, set up, carry out and analyze experimental data.

Understand rules for shipping and recieving materials, temperature requirements, and when materials should be quarantined.

Use M1V1 = M2V2 or C1V1 = C2V2 to calculate a concentration or determine the amount of a liquid to use in making a solution.

Be able to use descriptive statistics to characterize a data set.

The FDA protects public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of the U.Ss food supply, cosmetics, and products that emit radiation. They also regulate tobacco. Many biotechnology ...

Know how to perform IQ, OQ, PQ (Installation Qualification, Operational Qualification, Performance Qualification). These are three activities that must be performed on equipment and machines as part of the validataion of manufacturing processes.