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Biotech Job Descriptions - Part 1

BIO. "Biotechnology: The Choice for Your Future. A Resource Guide." Washington, D.C.: Biotechnology Industry Organization.

Research & Development

Glasswasher
A glasswasher is responsible for washing and drying glassware and distributing it to appropriate locations within the laboratories. He or she maintains the glass-washing facility, keeping it clean and swept, and picks up dirty glassware. He or she may sterilize glassware and other items using an autoclave. A glasswasher performs routine maintenance of glass-washing equipment and performs other related duties as required. A glasswasher position requires a high school diploma or equivalent and a minimum of 0 to 2 years' laboratory experience.

Laboratory Assistant
Laboratory assistants are responsible for performing a wide variety of research laboratory tasks and experiments, making detailed observations, analyzing data, and interpreting results. He or she maintains laboratory equipment and inventory levels for laboratory supplies. He or she may also write reports, summaries, and protocols regarding experiments. A laboratory assistant also performs limited troubleshooting and calibration of instruments. An entry-level laboratory assistant position requires at minimum an associate degree in a science and 0 to 2 years' laboratory experience.

Research Associate
A research associate is responsible for research and development in collaboration with others on projects. He or she makes detailed observations, analyzes data, and interprets results. Research associates prepare technical reports, summaries, protocols, and quantitative analyses. An incumbent maintains familiarity with current scientific literature and contributes to the process of a project within his or her scientific discipline, as well as investigating, creating, and developing new ethods and technologies for project advancement. He or she may also be responsible for identifying patentable inventions and acting as principal investigator in conducting his or her own experiments. A research associate may also be asked to participate in scientific conferences and contribute to scientific journals.

Research Assistant
The job description for a research assistant is similar to that of a research associate. At the entry level, the job can require a bachelor of science or advanced degree in a scientific discipline or equivalent, with little or no related experience.

Postdoctoral Fellow
The postdoctoral fellow, with a Ph.D. but little or no job experience, joins the staff for a maximum of two to three years to gain necessary experience before moving onto a more senior scientist position.

Media Prep Technician
A media prep technician is responsible for media preparation in the research and development area. He or she performs experiments as required and outlined, and develops and maintains record keeping for procedures and experiments performed. A media prep technician entry-level position requires at minimum an associate degree in science and 0 to 2 years' related experience and/or completion of a company's on-the-job training program.

Greenhouse Assistant
A greenhouse assistant performs a variety of greenhouse research tasks and experiments. He or she may be required to make detailed observations, detecting horticultural or pest problems, and instituting corrective action. Greenhouse assistants determine optimal cultural requirements and perform tasks related to disease and pest prevention; they often are required to collect, record, and analyze data, as well as interpret results. In addition, a greenhouse assistant may be called upon to perform troubleshooting and equipment maintenance. An entry-level greenhouse assistant position requires a high school diploma, an associate degree or equivalent, and a minimum of 0 to 2 years' relevant greenhouse/ plant experience.

Plant Breeder
A plant breeder is responsible for the design, development, execution, and implementation of plant breeding research projects in collaboration with a larger research team. He or she may be responsible for project planning and personnel management within the project. Plant breeders may use exotic germ plasm and work with various mating systems and integrate them with biotechnology as needed to enhance selection methods and accelerate product development.

A plant breeder's diverse responsibilities can include making contributions to and developing good public relations with scientific and other professional communities. He or she may also act as an adviser to company management about long-range goals for a plant breeding department. He or she may participate in the development of patents or proposals and assist with the management and development of a plant breeding group.

A plant breeder entry-level position requires a bachelor of science degree or equivalent. A minimum of 0 to 2 years of plant breeding or agronomical experience and/or training in plant breeding or plant science is also required.


Quality Control

Quality Control Analyst
A quality control analyst is responsible for conducting routine and nonroutine analysis of raw materials. He or she compiles data for documentation of test procedures and reports abnormalities. A quality control analyst also reviews data obtained for compliance with specifications and reports abnormalities. He or she revises and updates standard operating procedures and may perform special projects on analytical and instrument problem solving. An entry-level quality control analyst's position requires a bachelor of science degree in a scientific discipline or equivalent and a minimum of 0 to 2 years' experience in quality control systems.

Quality Control Engineer
A quality control engineer is responsible for developing, applying, revising, and maintaining quality standards for processing materials into partially finished or finished products. He or she designs and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and prepares documentation for inspection testing procedures. Depending on the job level, a quality control engineer is responsible for ensuring conformance to in-house specifications and good manufacturing practices and may conduct training programs. He or she may also be responsible for and supervise the development and efforts of a quality control engineering group. The entry-level job requires a bachelor of science degree or equivalent and a minimum of 0 to 2 years' experience in quality control systems.

Environmental Health and Safety Specialist
An environmental health and safety specialist is responsible for developing, implementing, and monitoring industrial safety programs within the company. He or she inspects plant areas to ensure compliance with Occupational Safety and Health Administration (OSHA) regulations. He or she evaluates new equipment and raw materials for safety, and monitors employee exposure to chemicals and other toxic substances. A safety specialist, depending on the job level, may also conduct training programs in hazardous waste collection, disposal, and radiation safety regulations. An entry-level safety specialist job requires a bachelor of science degree or equivalent and a minimum of 0 to 2 years' related experience.

Quality Assurance Auditor
A quality assurance auditor is responsible for performing audits of production and quality control. He or she ensures compliance to in-house specifications, standards, and good manufacturing practices. The job requires a bachelor of science degree in a scientific discipline or equivalent and a minimum of 0 to 2 years' experience in biological or pharmaceutical manufacturing.

Validation Engineer
A validation engineer is responsible for the calibration and validation of equipment and systems and for assisting in the selection, specification, and negotiation of competitive pricing of equipment. He or she maintains all of the documentation pertaining to qualification and validation and serves as an information resource for validation technicians, contractors, and vendors.

At the entry-level, the job requires a bachelor of science degree or equivalent, with 0 to 2 years' related experience.

Validation Technician
An entry-level validation technician would be responsible for developing, preparing the installation of, and revising test validation procedures/protocols to ensure that a product is manufactured in accordance with appropriate regulatory agency validation requirements, internal company standards, and current industry practices. A validation technician compiles and analyzes validation data, prepares reports, and makes recommendations for changes and/or improvements. He or she may also investigate and troubleshoot problems and determine solutions. He or she maintains appropriate validation documentation and files. An entry-level validation technician requires a high school diploma or equivalent and a minimum of 0 to 2 years' related experience.


Clinical Research

Clinical Research Administrator
A clinical research administrator is responsible for clinical data entry and validation to ensure legibility, completeness, and consistency of data. He or she assists users with requests for clinical documents and is responsible for working with physicians and/or their staff to clarify any questionable information. He or she may be responsible for auditing internal patient files and studies and for assisting with the development and evaluation of clinical record documents.

A clinical research administrator, at the entry level, typically develops internal record keeping system(s), including maintaining and auditing data and providing status and activity reports as required. The job requires a high school diploma or equivalent, with a minimum of 0 to 2 years' related experience.

Clinical Coordinator
A clinical coordinator must be familiar with the scientific/investigative process. Expertise may be limited to a specific functional area. A clinical coordinator must have good communications skills, both written and oral. He or she must also have project team experience and a familiarity with standard computer applications. Responsibilities include coordinating the clinical development plan as outlined by the company or Clinical Department, defining objectives, strategy, and studies. The clinical coordinator must provide support for planning, including detailed effort estimates, scheduling, and critical path analysis. He or she must monitor clinical activities to identify issues, variances, and conflicts, and analyze and recommend solutions. The clinical coordinator is responsible for project staffing requirements and tracking drug supply to outside vendors, as well as providing ongoing, objective updates on progress and problems with projects, tracking and following up on action items. The position requires a bachelor of science or a bachelor of arts degree in Health Science, Information Technology, or Business and 3-5 years of experience in the health care industry.

Clinical Programmer
A beginning clinical programmer is responsible for coordinating and monitoring the flow of clinical data into the computer database. He or she analyzes and evaluates clinical data, recognizes inconsistencies, and initiates the resolution of data problems. He or she implements data management plans designed to meet project and protocol deadlines, and consults in the design and development of clinical trials, protocols, and case report forms. A clinical programmer also acts as liaison between clinical management and subcommittees and project teams on an as-needed basis. An entry-level position as a clinical programmer requires a bachelor of science degree or equivalent, although a master of science degree is often preferred. A minimum of 0 to 2 years' experience in pharmaceutical programming in the clinical research area is also required.

Biostatistician
A biostatistician works with others to define and perform analyses of databases for publications, presentations to investigator meetings, and for meetings of professional societies. A position as a biostatistician requires at least a master's degree in biostatistics and 1 to 4 years' related experience.

Clinical Data Specialist
A clinical data specialist is responsible for collaborating with various departments on the design, documentation, testing and, implementation of clinical data studies. He or she develops systems for organizing data to analyze, identify, and report trends. A clinical data specialist also analyzes the interrelationships data and defines logical aspects of data sets. A starting position as a clinical data specialist requires a bachelor of science degree or equivalent and a minimum of 0 to 2 years' related experience.

Drug Experience Coordinator
The major responsibility of a drug experience coordinator is to handle the drug experience activities for marketed products. The candidate will also provide drug information on the products. He or she will oversee day-to-day processing of adverse event information for marketed products and ill coordinate the receipt, classification, investigation, and processing of adverse experience reports. A position as a drug experience coordinator requires a Pharm D or equivalent clinical training and 0 to 2 years' related experience.

Clinical Research Associate
A clinical research associate is responsible for the design, planning, implementation, and overall direction of clinical research projects. He or she evaluates and analyzes clinical data and coordinates activities of associates to ensure compliance with protocol and overall clinical objectives. He or she may also travel to field sites to supervise and coordinate clinical studies. An entry-level clinical research associate position typically requires a bachelor of science, a registered nurse degree or equivalent, and a minimum of 0 to 2 years' clinical experience in medical research, nursing, or the pharmaceutical industry. Knowledge of FDA regulatory requirements is also preferred.

Animal Handler
An animal handler is responsible for the daily care of research animals for experimental purposes. He or she cleans animal cages and racks, maintains records to comply with regulatory requirements and standard operating procedures, and performs preventive maintenance on facility equipment. The incumbent may also perform animal observation, grooming, and minor clinical tasks. An animal handler position requires a high school diploma or equivalent experience with a scientific background. A minimum of 0 to 2 years' relevant laboratory experience is also expected.

Animal Technician
Animal technicians are responsible for the daily care of research animals for experimental purposes. They also coordinate with vendors and supervisors on operational, administrative, and technical responsibilities. They perform some surgery and postoperative care as directed and are responsible for overseeing procurement of animals and supplies, preventive maintenance of facility equipment, cleaning of animal cages and racks, daily rounds, and observation to check animal health status. They develop standard operating procedures and maintain records to comply with regulatory requirements. An entry-level animal technician job requires a high school diploma or equivalent experience with a scientific background and a minimum of 0 to 2 years' related laboratory experience.

Technical Writer
An entry-level technical writer is responsible for writing and editing standard operating procedures, clinical study protocols, laboratory procedure manuals, and other related documents. He or she edits and/or rewrites various sources of information into a uniform style and language for regulatory compliance, and assists in developing documentation for instructional, descriptive, reference, and/or informational purposes. An entry-level position requires a bachelor of science degree or equivalent and a minimum of 0 to 2 years of experience in writing technical documentation.


Go to: Job Descriptions Part 2


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