Unit3 on the-job

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Careers in a Typical Bioscience Company

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Transcript of Unit3 on the-job

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Careers in a Typical Bioscience Company

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Often takes many companies to bring a product to market

Research and development startupsContract research and testing

companiesClinical research organization (CROs)Specialized vendors

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Certificate programs and short courses (less than a two-year degree program)

Two-year degree programs: Associate of Science (A.S.), Associate of Applied Science (A.A.S.)

Four-year degree programs: Bachelor of Science (B.S.), Bachelor of Arts (B.A.)

Graduate degrees: Ph.D., Master of Science (M.S.), Professional Science master’s degree

Professional degrees: Doctor of Medicine (M.D.), Juris Doctor (J.D.)

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Critical in guiding the research, development and manufacturing work central to biotechnology and other industries by developing and leading the innovative thinking around new products

Educational Requirements and Preferences Require M.S. or Ph.D. in a specialized disciplines

such as chemistry (especially organic and medicinal chemistry), cell biology, molecular biology, toxicology, genetics, immunology and biochemistry.

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Discovery Research ScientistWorks with a team to identify new

drug targetsCreates animal models to test new

drugs and investigating the causes of and treatments for diseases

Chemistry (especially organic and medicinal chemistry), cell biology, molecular biology, genetics, immunology and biochemistry

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Process Development Scientist

Designs and executes experiments associated with the development, improvement and scale-up of production processes

Interfaces with engineering groups and laboratory groups

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Quality Control Manager

Manages personnel Manages activities needed

to analyze raw materials in-process samples and finished formulations according to standard operating procedures (SOPs)

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ToxicologistDesigns experiments and research

studies focused on evaluating the harmful effects of a potential product on human health or the environment

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Other job titles include…ChemistMicrobiologistBiochemistNatural science managerResearch and development scientist

Research associateEnvironmental scientist

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Career PathwaysManagement responsibilities

Overall business planning

Overseeing projects and other personnel

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Work under the discretion of a scientist or engineerEssentially the scientist’s handsWork in the laboratoryPerforming research experiments according to good laboratory practicesCollecting and analyzing data

Educational Requirements and Preferences Two or four year degree

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Research Assistant/AssociatePerform lab experiments and test

according to good laboratory practices under the direction of a research associate

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Process Development Associate

Seeks out new and more efficient ways to use and produce existing products

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Process Quality Inspector

Performs a wide variety of inspections, checks, tests, and sampling procedures related to the manufacturing process

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Quality Control AssociateAnalyzes raw materials, in-process

samples and finished formulations according to SOPs

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Career PathwaysGreat stepping stoneSenior roles in quality control and quality assurance roles

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Critical to building, optimizing, maintaining and operating state-of-the-art

biomanufacturing facilities and use computer software to visualize the complete manufacturing process

Educational Requirements and Preferences B. S. in engineering and some require M.S. or

Ph.D. in a specialized engineering disciplines such as biochemical, biomedical, chemical, electrical, environmental, food science, industrial, materials science and mechanical.

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Process Engineer (Manufacturing)

Develop and operate the current manufacturing process and works with technicians to ensure the product is properly manufactured

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Quality Control EngineerDevelops, revises and maintains standards for converting raw materials into products and devises SOPs for testing procedures

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Maintenance EngineerManages the design, planning,

construction and maintenance of facilities, and oversees repairs to refrigeration, air conditioning, steam boilers, etc.

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Process Control Engineer

Designs and installs instruments to monitor and control certain manufacturing processes and helps improve manufacturing techniques

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Environmental EngineerDevelops techniques to recover

reusable materials from waste created during manufacturing and designs water storage and treatment facilities

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Career PathwaysManagement responsibilitiesOverseeing projects and personnel

Corporate scientific professional, such as quality assurance or validation

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Responsible for operating the equipment and processes necessary to manufacture

batches of product

Educational Requirements and Preferences Completed a certificate course, two-year

degree, and four-year degree

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Process TechnicianResponsible for a variety of tasks

involved in the monitoring and control of producing the product

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Manufacturing Prep Process TechnicianResponsible for washing, drying, and sterilizing glassware

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Formulation/Fill TechnicianResponsible for preparing the finished

product form the purified active pharmaceutical or biopharmaceutical ingredients

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Packaging TechnicianUses packaging systems to label,

inspect and package the finished product

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Career PathwaysStepping stoneLaboratory technician role, such as quality control

Corporate scientific professional roles, such as quality assurance

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Vital to the ongoing operation of a manufacturing facility and are responsible

for repairing equipment and electrical circuits, calibrating instruments and

installing and validating new equipment

Educational Requirements and Preferences Completed a certificate course or two-year

degree

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Instrumentation/Calibration Technician

Responsible for calibrating, testing, troubleshooting, repairing and maintaining a variety of circuits, components, analytical equipment and instrumentation

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Manufacturing Support TechnicianMaintains manufacturing equipment and solves production problems caused by machinery

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Environmental TechnicianPerforms routine environmental

testing and carries out waste treatment operations

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Career PathwaysManagement responsibilities

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Critical to keeping the bioscience business moving

Educational Requirements and Preferences Four-year degree in science with additional

education in business, law, medicine/health care or communication

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Quality Assurance Associate/Manager

Ensures the quality of all manufacturing and laboratory operations by verifying compliance with Good Manufacturing Practice (GMP)

Writing and updating SOPs Reviewing data for abnormalities Resolving problems that occurred during

manufacturing or research.

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Quality Assurance AuditorPerforms audits of production and

quality control to ensure compliance with in-house procedures, standards and regulatory requirements.

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Validation Specialist/Scientist/Engineer

Verify that equipment, processes and procedures are working as they are intended by designing and executing experimental protocols.

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Clinical Research Associate (CRA)

Assists in the monitoring and management of clinical trials

Requires knowledge of drug development, clinical research (studies in humans), federal regulations and Good Clinical Practice (GCP).

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Regulatory Affairs SpecialistCoordinates and prepares a variety of documents to submit to the FDA

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Customer Support Specialist (four-year degree)

Serves as a contact for customers with technical product questions

Ensures delivery of product that meets customers’ requirements

Customer support experiences desired

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Other job titles include…Project managerSales representativeMarketing specialistPatent attorneyCorporate trainerLawyerTechnical writer

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Career PathwaysManagement responsibilities