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Biotech Job Descriptions - Part 2

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

Manufacturing and Production

Product Development Engineer
A product development engineer, at the entry level, is responsible for the design, development, modifications to, and enhancements of existing products and processes. The position is involved in new product scale-up, process optimization, technology transfer, and process validation. He or she ensures that processes and design implementations are consistent with good labor and manufacturing practices. A product development engineer may also be responsible for contact with outside vendors and for the administration of contracts to accomplish goals. A product development engineer works on problems of moderate scope, where analysis of a situation or data requires a review of identifiable factors. The job requires a bachelor of science degree or equivalent and 0 to 2 years' related experience.

Production Planner Scheduler
A production planner scheduler is responsible for planning, scheduling, and coordinating the final approval of products through the production cycle. He or she coordinates production plans to ensure that materials are provided according to schedules to maintain production and provides input to management. When necessary, a production planner scheduler works with the Customer Service, Marketing, Production, Quality Control, and Sales departments to review back order status, prioritize production orders, and deal with other potential schedule interruptions or rescheduling. An entry-level production planner scheduler requires a bachelor's degree or equivalent and a minimum of 0 to 2 years' related experience.

Manufacturing Technician
Manufacturing technicians are responsible for the manufacture and packaging of potential and existing products. They operate and maintain small production equipment; weigh, measure, and check raw materials, and ensure that manufactured batches contain the proper ingredients and quantities. They maintain records and clean production areas to comply with regulatory requirements, good manufacturing practices, and standard operating procedures. A manufacturing technician may also assist with in-process testing to make sure that batches meet product specifications. An entry-level position requires an associate degree in science and a minimum of 0 to 2 years' related experience in a manufacturing environment.

Packaging Operator
A packaging operator uses manual and/or automated packaging systems to label, inspect, and package final container products. He or she also enters data and imprints computer-generated labels, maintains records, and maintains the manufacturing/ production area to comply with regulatory requirements, good manufacturing practices, and standard operating procedures. A packaging operator may also perform initial checks of completed documents for completeness and accuracy. The position requires a high school diploma or equivalent and a minimum of 0 to 2 years' experience in a manufacturing environment.

Manufacturing Research Associate
A manufacturing research associate is responsible for the implementation of production procedures to optimize manufacturing processes and regulatory requirements, and has responsibilities in packaging and distribution processes. He or she may also help maintain production equipment. The position requires a bachelor of science degree in a scientific discipline or equivalent and a minimum of 0 to 2 years' experience in a manufacturing environment.

Instrument / Calibration Technician
An entry-level instrument/calibration technician is responsible for performing maintenance, testing, troubleshooting, calibration, and repair on a variety of circuits, components, analytical equipment, and instrumentation. He or she also calibrates instrumentation, performs validation studies, and specifies and requests purchase of components. He or she analyzes results, may develop test specifications and electrical schematics, and maintains logs and required documentation. An instrument/calibration technician also maintains spare parts inventories and may prepare technical reports with recommendations for solutions to technical problems. An associate degree in electronics technology or equivalent is required, as is a minimum of 0 to 2 years' related experience.

Biochemical Development Engineer
A biochemical development engineer is responsible for the design and scale-up of processes, instruments, and equipment from the laboratory through the pilot plant and manufacturing process. He or she assists the manufacturing operations in problem solving with regards to equipment and systems and participates in the design and start-up of new manufacturing facilities and equipment. He or she develops and recommends new process formulas and technologies to achieve cost effectiveness and product quality. A biochemical development engineer also establishes operating equipment specifications and improves manufacturing techniques. A biochemical development engineer is involved in new product scale-up, process improvement, technology transfer, and process-validation activities. He or she works with various departments to ensure that processes and designs are compatible for new product technology transfer and to establish future process and equipment automation technology. The position requires a bachelor of science degree in biological, chemical, or pharmaceutical engineering, or a related discipline. A minimum of 0 to 2 years' experience is also required, preferably in the areas of pharmaceutical processes or research product development.

Process Development Associate
A process development associate is responsible for the implementation of production procedures to optimize manufacturing processes and regulatory requirements. He or she may also assist in process development, in creating scalable processes with improved product yield and reduced manufacturing systems costs. A process development associate, at the entry level, may also be involved in packaging and distribution processes and in the maintenance of production equipment. He or she may research and implement new methods and technologies to enhance operations. The position requires a bachelor of science degree in a scientific discipline or equivalent and a minimum of 0 to 2 years' experience.

Assay Analyst
An assay analyst is responsible for doing cell cultures and performing assays and tests on tissue and cell cultures following standard protocols. He or she prepares glassware, reagents and media for cell culture use. He or she also performs, prepares and maintains tissues and cell cultures and maintains records required by good manufacturing procedures. An assay analyst also participates in the modification of assay procedures for routine implementation. The position requires a high school diploma or equivalent and a minimum of 0 to 2 years' related experience.

Manufacturing Engineer
A manufacturing engineer is responsible for developing, implementing, and maintaining methods, operation sequences, and processes in manufacturing. He or she works with the engineering department to coordinate the release of new products. He or she estimates manufacturing costs, determines time standards, and makes recommendations for process requirements of new or existing product lines. As required, a manufacturing engineer also maintains records and reporting systems for the coordination of manufacturing operations. An entry-level job as a manufacturing engineer requires a bachelor of science degree in a scientific discipline or equivalent and a minimum of 0 to 2 years of related experience, preferably in research product development or a manufacturing environment.


Regulatory Affairs

Regulatory Affairs Specialists
A regulatory affairs specialist, at the entry level, coordinates and prepares document packages for submission to regulatory agencies, internal audits, and inspections. He or she compiles all material required for submissions, license renewals, and annual registrations. An incumbent monitors and improves tracking and control systems and keeps abreast of regulatory procedures and changes. He or she may work with regulatory agencies and recommend strategies for earliest possible approvals of clinical trial applications. An entry-level position requires a bachelor of science degree or equivalent and a minimum of 0 to 2 years' related experience.

Documentation Coordinator
A documentation coordinator provides clerical and administrative support related to a company's documentation system requirements. He or she audits all documentation manuals to ensure that they are accurate and up-to-date and available to appropriate personnel. A documentation coordinator also files and retrieves all master documents. The position requires a high school diploma or equivalent and a minimum of 0 to 2 years' related experience.

Documentation Specialist
An entry-level documentation specialist is responsible for coordinating all activities related to providing required documentation and implementing related documentation systems. He or she coordinates the review and revision of procedures, specifications, and forms. He or she also assists in compiling regulatory filing documents and in maintaining computerized files to support all documentation systems. The job requires a bachelor of science degree in a related field or equivalent and a minimum of 0 to 2 years' experience in documentation, quality assurance, technical writing or the equivalent.


Information Systems

Library Assistant
A library assistant maintains serial control, and locates and orders journal articles and/or books that are unavailable at local libraries on relevant subjects. He or she performs special data-gathering projects as requested, and is responsible for on-line computer searching of scientific databases. The position of entry-level library assistant requires an associate degree or equivalent and a minimum of 0 to 2 years' relevant library experience or the completion of an on-the-job training program.

Scientific Programmer Analyst
Scientific programmer analysts design, develop, evaluate, and modify computer programs for the solution of scientific or engineering problems and for the support of research and development efforts. He or she analyzes existing systems and formulates logic for new systems. A scientific program analyst also devises logical procedures, prepares flow charts, performs coding, tests, and debugs programs. He or she provides input for the documentation of new or existing programs, and determines system specifications, input/output processes, and working parameters for hardware/software compatibility. An analyst also contributes to decisions on policies, procedures, expansion strategies, and product evaluations.

An entry-level scientific programmer analyst position requires a bachelor of science degree in a related discipline or equivalent and a minimum of 0 to 2 years' experience.


Marketing & Sales

Market Research Analyst
\ A market research analyst is responsible for researching and analyzing the company's markets, competition, and product mix. He or she performs literature research, analyzes and summarizes data, and makes presentations on new market and technical areas. He or she also analyzes the competitive environment, as well as future marketing trends, and makes appropriate recommendations. He or she conducts market surveys, summarizes results, and assists in the preparation, presentation, and follow-up of research proposals. An entry-level position as a market research analyst requires a bachelor's degree or equivalent and a minimum of 0 to 2 years of experience in market research, competitive analysis, and product planning, as well as excellent writing skills.

Systems Analyst
A systems analyst is responsible for system level software and for maintenance of the operating system(s), various layered products, system tuning, and various levels of user assistance. The systems analyst is responsible for the operation of all system software, performing upgrades, and maintaining related system and user documentation. He or she assists in the impementation of system validation and documentation, in system capacity planning, and system configuration. In addition, the systems analyst trouble shoots system-related problems and interacts with vendors. An entry-level position as a systems analyst requires a degree in data processing and a minimum of 0 to 2 years of experience.

Sales Representative
A sales representative is responsible for direct sales of company products or services. He or she calls on prospective customers, provides product information and/or demonstrations, and quotes appropriate customer prices. A sales representative is also responsible for new account development and growth of existing accounts within an established geographic territory. A sales representative must meet assigned sales quotas and may handle key company accounts or act as an account manager for national or major accounts. Depending on the level of the position, an experienced incumbent may also assist in the training of other sales representatives. An entry-level sales representative position requires a bachelor's degree or equivalent, and a minimum of 0 to 2 years of related sales experience and some knowledge of the company's products.

Customer Service Representative
Customer service representatives are responsible for ensuring product delivery in accordance with customer requirements and manufacturing capabilities and for responding to customer product inquiries and satisfaction issues. He or she answers telephones, takes product orders, and inputs sales order data into consumer data systems. He or she also investigates problems related to the shipment of products, credits, and new orders. He or she may also be responsible for sale order administration and/or inside sales. The entry-level position requires a college education or equivalent, with preference toward a bachelor of science degree in a technical or scientific field. A minimum of 0 to 2 years' related experience in diagnosing and troubleshooting products in the pharmaceutical industry may also be required.

Technical Services Representative
A technical services representative provides technical direction and support to customers on the operation and maintenance of company products. He or she also serves as a contact for customers on technical and service-related problems. A technical services representative also demonstrates uses and advantages of products. An entry-level technical services representative position requires an associate's degree or equivalent and a minimum of 0 to 2 years of experience.


Administration

Technical Recruiter
A technical recruiter is responsible for recruiting, interviewing, and screening applicants for technical exempt and nonexempt positions. He or she coordinates preemployment physicals, travel, reporting dates, security clearances, and employment processing for new hires. He or she also conducts employee advertising and reviews employment agency placements. In addition, a technical recruiter maintains college recruiting, affirmative action, and career development programs. An entry-level position as a technical recruiter requires a bachelor of science degree or equivalent and a minimum of 0 to 2 years' experience.

Human Resources Representative
A representative in human resources is responsible for a variety of activities in personnel administration, including employment, compensation and benefits, employee relations, equal employment opportunity, and training programs. He or she conducts job interviews, counsels employees, maintains records, and conducts research and analyzes data on assigned projects. An entry-level position as a human resources representative requires a bachelor of science degree or equivalent and a minimum of 0 to 2 years' related experience.

Buyer
A buyer is responsible for obtaining materials, scientific equipment, and services. He or she checks requisitions, obtains price quotations, examines bids, and awards contracts. A buyer develops new supply sources where vendors and suppliers are inadequate. He or she coordinates purchasing activities with other departments to maintain inventory at planned levels. As required, a buyer also monitors the cost, schedule, and scope of assigned subcontracts to ensure the quality and value of the contract. An entry-level buyer position requires a bachelor of science degree in a scientific discipline or equivalent and a minimum of 0 to 2 years' experience in purchasing, preferably in a scientific area.

Patent Administrator
A patent administrator is responsible for preparing and coordinating all procedural documentation for patent filings and applications. He or she tracks in-house research studies and recommends the need for and timing of patent filings. A patent administrator also assists attorneys with the drafting and editing of patent applications and collects and evaluates supporting data. This position requires the maintenance of a tracking system to comply with trademark regulations. He or she may also be called upon to assist with determining the necessity and approach to contracts to ensure protection of the company's proprietary technology. A patent administrator is also typically responsible for tracking and paying legal fees. An entry-level patent administrator position requires a bachelor of science degree or equivalent and a minimum of 0 to 2 years' experience.

Patent Agent
A patent agent is responsible for preparing, filing, and processing patent applications for the company. He or she negotiates and drafts patent licenses and other agreements. A patent agent also conducts state-of-the-art searches and may assist with appeal and interference proceedings. A patent agent also performs other duties as required. The entry-level patent agent position requires a bachelor of science degree or equivalent with 0 to 2 years' related experience. It also requires registration to practice before the U.S. Patent and Trademark Office.


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