UNIT 3 .04

Career Opportunities

By PresenterMedia.com

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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