Diversity of Biotech Careers

Research and Product Development 

• Research Associate
  Responsible for performing research and development experiments for projects and products, in collaboration with others.  Regularly exercises technical discretion in the design, execution and interpretation of experiments that contribute to project goals.  Contributes to project process within scientific discipline through innovative research.  Prepares technical reports, summaries, protocols and quantitative analyses.
• Research Assistant
  Responsible for performing research and development experiments for projects and products, in collaboration with others.  Projects may  require the exercise of technical discretion in the design, execution or interpretation of experiments.  Makes detailed observations, analyzes data and interprets results.  Prepares technical reports, summaries, protocols and quantitative analyses.
• Clinical Research Associate
  Key participant in the design, implementation and monitoring of clinical trials, preparation of integrated medical reports, INDs, Investigational Device Exemptions (IDE), periodic reports, PLAs, etc. Participates in design and writing of protocols, case report forms and informed consent forms for clinical trials.  Productive in recruitment/selection of new investigators, contract research organizations and outside vendors.  Responsible for planning and implementing all activities required to conduct and monitor complex clinical trials and ensure that Good Manufacturing Practices (GMP) are followed.  Conducts site visits pre-study, at study initiation, at regular intervals during the study and at closeout.  Monitors investigator performance and adherence to protocol.
• Clinical Data Associate
  Primary responsibility is to ensure the validity of clinical trials and format them for statistical purposes.  Also designs collection instruments, sets up databases and tracks and manages the flow of data to and from the investigative sites.  With supervision, establishes protocol-specific data review and entry guidelines to document the validation and formatting procedures and defines batch-ending programs.  Monitors timely data entry.  Review data discrepancies resolutions provided by the investigative sites and enter corrections into the database, as appropriate.  Assists in the review of interim/final data listings prior to transmission to other groups or inclusion in interim/final reports.
• Clinical Database Programmer Analyst
  Works as part of a project team or possibly as a team manager, to design and implement applications in support of Clinical Research and Biostatistics.  Leads the analysis, design and implementation of client-server applications such as Oracle, SQL and forms of GUI-based products.  Develops forms, menus and reports based on functional and design specifications.  Documents all work fully according to Clinical Information Systems (CIS) standards.  Actively promotes standards for the development and acquisition of systems.  Participates in the evaluation and implementation of packaged systems.
• Database Specialists
  Provides for the storage and retrieval of research data for decision-making, intellectual property submissions, regulatory petitions, and due-diligence purposes.  In addition, the positions may monitor current publications, research and available references.

Regulatory Affairs

• Scientific Writer
  Responsible for the timely preparation, production and quality control of regulatory documents, including coordinating with regulatory project teams, creating editorial timelines and work flow specifications, scheduling and tracking documents, assessing documentation staffing needs, participating in "round table" review of documents, establishing project specific style guidelines, editing at various levels, writing and proofreading.  Develops and updates specifications for the design, format production elements, tracking of regulatory documents and artwork used in regulatory documents.
• Documentation Assistant
  Responsible for coordination and administration of document production procedures, including planning and scheduling of work processing and production resources.  Coordinates with project teams in the development of timelines for regulatory submissions.  Manages electronic files.  Coordinates with Scientific Editor to develop and update specifications and procedures for design and format of documents and artwork policy and procedures.  Oversees reference collection, archive system, and produces monthly and annual reports of regulatory submissions.
• Government and Regulatory Affairs Specialists
  Provides support for regulatory submissions to FDA, EPA, USDA, and state/local regulatory authorities.  The position requires an understanding and conversant ability in the area of technology and life sciences that the companies represent.

Manufacturing/Cell Culture and Fermentation Systems

• Cell Culture Research Associate
  Maintains cell master and secondary banks.  Produces cell and virus titers/volumes in response to manufacturing schedule.  Performs related cell culture activities including: preparing media and components; carrying out roller bottle production on various cell lines; establishing cell and viral titers; assisting in development of in-process testing (i.e. sterility, viability, cell counts, protein expression).  Harvests cells, maintains compliance with GMPs involved in cell culture, writes updates for production procedures as needed, and coordinates efforts with Quality Control, Quality Assurance and Materials Management.
• Process/Pilot Plant Technician
  Responsible for the successful completion of all cell culture and bioprocessing activities as required to maintain protein production levels in compliance with GMPs involved in cell culture.  Assists in writing production procedures.
• Manufacturing Supervisor
  Responsible for supervising the transference of cell culture and fermentation methods from research and development to manufacturing.  Implements and maintains production schedules and manpower requirement.  Directly provides guidance to employees to ensure GMPs.  Provides general supervision over a work group, assigning tasks and checking work at regular intervals.

Production/Purification

• Purification Supervisor
   Supervises and maintains manufacturing purification production methods, processes and operations for new or existing products.  Implements and maintains production schedule and manpower requirements.  Works on problems where analysis of situation or data requires a review of identifiable factors.  Exercises judgment within defined procedures and policies.  Ensures GMP, GLP and SOP compliance.
• Research Associate
  Implements production procedures to optimize the manufacturing processes and regulatory requirements.  May assist process development in developing scalable processes with improved product yield and reduced costs for the purification manufacturing systems.  May be involved in packaging and distribution processes.  May assist maintenance of production equipment.  Works on problems where analysis of situation or data requires a review of identifiable factors.
• Process/Pilot Plant Technician
  Assists manufacturing in production scale protein purification and manufacture of final products.  Operates chromatography equipment.  Prepares buffers used in the purification process.  Performs in-process testing.  Maintains records to comply with regulatory requirements, GMPs and standard operating procedures.

Production/Aseptic Fill

• Aseptic Fill Supervisor
   Supervises and maintains aseptic fill production methods, processes and operations for new or existing products.  Implements and maintains production schedule and manpower requirements for the aseptic fill area.  Works on problems where analysis of situation or data requires a review of identifiable factors.
• Aseptic Fill Research Associate
  Implements production procedure to optimize the aseptic fill manufacturing processes and regulatory requirements.  May assist process development in developing scalable processes with improved product yield and reduced costs for the aseptic fill manufacture systems.  May be involved in packaging and distribution processes.  May assist with maintenance of production equipment.
• Aseptic Fill Process/Pilot Plant Technician
  Assists in the implementation of the aseptic fill manufacturing process and regulatory requirements.  Assists in packaging and distribution process.  May assist with maintenance of production equipment.

Technical Affairs/Quality Control

• Quality Control Analyst
  Conducts routine and non-routine analysis of raw materials, in-process and finished formulations under supervision and according to Standard Operating Procedures (SOPs).  Compiles data for documentation of test procedures and prepares reports.  Calibrates and maintains lab equipment.  Reviews data obtained for compliance to specifications and reports abnormalities. Revises and updates SOPs.  May perform special projects on analytical instrument problem solving. 
• Quality Control Inspector
  Performs a wide variety of inspections, checks, tests and sampling procedures for the manufacturing process.  Performs in-process inspection and documents results.  Monitors critical equipment and instrumentation.  Writes and updates inspection procedures and checklists as necessary.
• Microbiology Quality Control Supervisor
  Designs, implements and validates microbiological testing protocols and recommends appropriate specifications for raw materials, key reagents, bulk and finished products. Establishes SOPs and key documentation systems for microbiological/environmental testing.  Implements validation studies for sterilization and autoclave cycles.  Establishes environmental monitoring to support GMPs.
• Quality Control Microbiologist
  Performs routine microbiological testing of raw materials, in-process samples and finished formulations according to Standard Operating Procedures (SOPs).  Conducts routine environmental monitoring of GMPs, manufacturing areas, equipment and processes according to established procedures.  Calibrates and maintains microbiology laboratory equipment.  Compiles and analyzes data for documentation of test results and prepares related reports.
• Quality Assurance Documentation Specialist
  Provides required documentation and implements documentation systems.  Coordinates the review and revision of procedures, specification and forms.  Assists in compiling regulatory filing documents and maintains computerized files to support all documentation systems.
• Quality Assurance Technical Writer
  Responsible for writing and editing SOPs, laboratory procedures manuals and regulated documents.  Integrates various sources of information into a uniform style and language for regulatory compliance.  Assists in documentation for instructional, descriptive, reference and/or informational purposes.
• Validation Supervisor
  Responsible for design and scale-up of processes, instruments and equipment from the laboratory through pilot plant and manufacturing.  Participates in the design and start-up of new manufacturing facilities and equipment.  Develops and recommends new process formulas and technologies to achieve cost effectiveness and product quality.  Interfaces with various departments to ensure processes and designs are compatible for new product technology transfers and to establish future processes and equipment automation technology.
• Product Technical Supervisor
  Coordinates the activity and technical positioning of product candidates or products.   The job includes technical writing and assistance with marketing messages from a technology and regulated point of view.  Critical position involved in the flow of many products through the development process.

Marketing and Sales

• Market Research Analyst
   Responsible for researching and analyzing the company's markets, competition and product mix.  Performs literature research, analyzes and summarizes data and makes representations on new market and technical areas.  Analyzes the competitive environment, as well as future marketing trends, and makes appropriate recommendations.  Conducts market surveys, summarizes results and assists in the preparation, presentation and follow-up of research proposals.
• Marketing Coordinator
  Assists in creating product initiatives and coordinates activity across disciplines for a commercial product.  Assists in the development of sales messages, features/advantages/benefits, advertising and distribution support.
• Sales Representative
  Responsible for direct sales of company products or services.  Calls on prospective customers, provides product information and/or demonstrations and quotes appropriate customer prices.  Also responsible for new account development and growth of existing accounts within an established geographic territory.  Must meet assigned sales quotas and may handle key company accounts. 
• Customer Service Representative
  Responsible for ensuring product delivery in accordance with customer requirements and manufacturing capabilities and responding to customer inquiries and satisfaction issues.  Answers telephones, takes product orders and inputs sales order data into data systems.  Investigates problems related to the shipment of products, credits and new orders.  May be responsible for sale order administration and/or inside sales.
• Technical Services Representative
  Provides technical direction and support to customers on operation and maintenance of company products.  Serves as a contact for customers on technical and service-related problems.  Demonstrates uses and advantages of products.