Unit3 on the-job
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Transcript of Unit3 on the-job
Careers in a Typical Bioscience Company
Often takes many companies to bring a product to market
Research and development startupsContract research and testing
companiesClinical research organization (CROs)Specialized vendors
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.)
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.
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
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
Quality Control Manager
Manages personnel Manages activities needed
to analyze raw materials in-process samples and finished formulations according to standard operating procedures (SOPs)
ToxicologistDesigns experiments and research
studies focused on evaluating the harmful effects of a potential product on human health or the environment
Other job titles include…ChemistMicrobiologistBiochemistNatural science managerResearch and development scientist
Research associateEnvironmental scientist
Career PathwaysManagement responsibilities
Overall business planning
Overseeing projects and other personnel
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
Research Assistant/AssociatePerform lab experiments and test
according to good laboratory practices under the direction of a research associate
Process Development Associate
Seeks out new and more efficient ways to use and produce existing products
Process Quality Inspector
Performs a wide variety of inspections, checks, tests, and sampling procedures related to the manufacturing process
Quality Control AssociateAnalyzes raw materials, in-process
samples and finished formulations according to SOPs
Career PathwaysGreat stepping stoneSenior roles in quality control and quality assurance roles
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.
Process Engineer (Manufacturing)
Develop and operate the current manufacturing process and works with technicians to ensure the product is properly manufactured
Quality Control EngineerDevelops, revises and maintains standards for converting raw materials into products and devises SOPs for testing procedures
Maintenance EngineerManages the design, planning,
construction and maintenance of facilities, and oversees repairs to refrigeration, air conditioning, steam boilers, etc.
Process Control Engineer
Designs and installs instruments to monitor and control certain manufacturing processes and helps improve manufacturing techniques
Environmental EngineerDevelops techniques to recover
reusable materials from waste created during manufacturing and designs water storage and treatment facilities
Career PathwaysManagement responsibilitiesOverseeing projects and personnel
Corporate scientific professional, such as quality assurance or validation
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
Process TechnicianResponsible for a variety of tasks
involved in the monitoring and control of producing the product
Manufacturing Prep Process TechnicianResponsible for washing, drying, and sterilizing glassware
Formulation/Fill TechnicianResponsible for preparing the finished
product form the purified active pharmaceutical or biopharmaceutical ingredients
Packaging TechnicianUses packaging systems to label,
inspect and package the finished product
Career PathwaysStepping stoneLaboratory technician role, such as quality control
Corporate scientific professional roles, such as quality assurance
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
Instrumentation/Calibration Technician
Responsible for calibrating, testing, troubleshooting, repairing and maintaining a variety of circuits, components, analytical equipment and instrumentation
Manufacturing Support TechnicianMaintains manufacturing equipment and solves production problems caused by machinery
Environmental TechnicianPerforms routine environmental
testing and carries out waste treatment operations
Career PathwaysManagement responsibilities
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
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.
Quality Assurance AuditorPerforms audits of production and
quality control to ensure compliance with in-house procedures, standards and regulatory requirements.
Validation Specialist/Scientist/Engineer
Verify that equipment, processes and procedures are working as they are intended by designing and executing experimental protocols.
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).
Regulatory Affairs SpecialistCoordinates and prepares a variety of documents to submit to the FDA
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
Other job titles include…Project managerSales representativeMarketing specialistPatent attorneyCorporate trainerLawyerTechnical writer
Career PathwaysManagement responsibilities