1. UNIT 3.04 Career Opportunities By PresenterMedia.comPresenterMedia.com

2. Biotechnology related research and development expenditures amounted to $16.4 billion in 2001 Employment is pharmaceutical & medicine manufacturing is projected to increase by 26% Creates jobs that are diverse, creating excellent employment opportunities in many different areas Biotechnology Generates Opportunities

3. Advantages of Working for Companies Involved in Bio- manufacturing:  1. Pride in you product  2. Higher Wages  3. Stable Employment  4. Modern and Professional Atmosphere  5. Safe Working Environments  6. Job Variety and Career Advancement Seizing the Opportunities

4. Production Positions  1. Entry Level positions-requires a high school diploma, a process technician certificate, or a two-year degree  Process technician: responsible for a variety of tasks involved in monitoring and control of producing the product  Manufacturing Pre Process Technician: responsible for washing, drying and sterilizing glassware  Formulation/Fill Technician: responsible for preparing the finished product from the purified active pharmaceutical or biopharmaceutical ingredients  Packaging Technician: Uses packaging systems to label, inspect & package the finished product Typical Bio-manufacturing Positions

5. Production  2. Entry Level Positions- requiring a four-year engineering degree Process Engineer in Process Development: responsible for the design, scale-up and validation of new processes from the laboratory to pilot- plant stage to large scale manufacturing Process Engineer in Manufacturing: Develops and operates the current manufacturing process and works with technician to ensure the product is properly manufactured Typical Bio-manufacturing Positions

6. Quality Control, Quality Assurance & Validation  Quality Control-involves checking the raw materials and product during every phase of its manufacture  Quality Assurance-focuses on the overall system of manufacturing  Validation-proves that a written procedure will consistently produce the product within certain specifications when carried out exactly Typical Bio-Manufacturing Positions

7. Quality Control, Quality Assurance & Validation  1. Entry Level Positions: requires a two year degree  Quality Control Assistant: analyzes raw materials, in-process samples and finished formulations according to SOPs  2. Entry Level Positions: requiring a 4 year degree  Quality Control Associates: coordinates activities needed to document good manufacturing practices  Quality Control Engineer: develops, revise and maintains standards for converting raw materials into products & devise SOPs for testing procedures  Quality Assurance Associate: Writes and edits SOPs, laboratory procedures, manuals, and other documents in a uniform style Typical Bio-Manufacturing Positions

8. Quality Control, Quality Assurance & Validation  3. Non-Entry Level Positions: requiring at least a 4 year degree and job experience in the industry  Process quality inspector: performs a wide variety of inspections, checks, tests and sampling procedures related to the manufacturing process  QA Auditor: performs audits of production and quality control to ensure compliance with in-house procedures, standards, and regulatory requirements  Validation Specialists: responsible for ensuring a product is manufactured in accordance with regulatory requirements & in-house standards Typical Bio-Manufacturing Positions

9. Manufacturing Support  1. Entry Level- requiring a high school diploma, specialized certification, or two-year degree  Instrumentation/Calibration Technician: responsible for calibrating, testing, troubleshooting, repairing and maintain a variety of circuits, components, analytical equipment and instrumentation  Manufacturing Support Technician: maintains manufacturing equipment and solves production problems caused by machinery  Environmental Technician: performs routine environmental testing and carries out waste treatment operations Typical Bio-Manufacturing Positions

10. Manufacturing Support  2. Entry –Level positions: requiring a 4 year degree  Manufacturing Engineer: manages the design, planning, construction and maintenance of facilities and oversees repairs to refrigeration, air conditioning, steam boiler etc..  Process Control Engineer: designs and installs instruments to monitor and control certain manufacturing processes and helps improve manufacturing techniques  Environmental Engineer: develops techniques to recover reusable materials from waste created during manufacturing and designs waster storage and treatment facilities Typical Bio-Manufacturing Positions

11. Research and Development  1. Entry-Level Positions-requiring either a 2 or 4 year degree  Research Assistant: performs lab experiments and tests according to good laboratory practices under the direction of research associate  Research Associate: seeks out new and more efficient ways to use and produce existing products Typical Bio-Manufacturing Positions

12. Research and Development  2. Entry-Level Position: requiring either a doctorate or master’s degree, plus experience  Research Scientist in Drug Discovery: works in a team in numerous areas, such as identifying new drug targets, creating animal models to test new drugs and investigating the causes of and treatment of disease  Process Development Scientists: design and execute experiments associated with the development, improvement and scale-up of production processes Typical Bio-Manufacturing Positions

13. Other Divisions  1. Positions that can be entry level or require industry experience  Customer Support Specialist: responsible for ensuring delivery of product that meets customers’ requirement  Clinical Trial Associate: assist in the monitoring and management of clinical trials Typical Bio-Manufacturing Positions

14. Other Divisions  2. Positions requiring at least a 4 year degree and experience in the industry  Regulatory Affairs Specialist: coordinates and prepares a variety of documents to submit to the FDA Typical Bio-Manufacturing Positions