On the Job

1. On the Job Careers in Biomanufacturing

2. Seizing the Opportunity • Bioprocess, pharmaceutical and chemical manufacturing jobs offer unique opportunities and benefits. • You will be working in a thriving industry. • You will be working in an industry in which skilled and competent employees are in great demand.

3. Seizing the Opportunity Advantages of working in this industry 1. Pride in your product You will have the satisfaction of making products that improve lives and boost the economy, including products that: • increase food production, making it possible to feed the world. • reduce infant deaths and prevent childhood diseases. • relieve painful symptoms, fight disease and save lives.

4. Seizing the Opportunity Advantages of working in this industry 2. Higher wages Employees in bioprocess, pharmaceutical and chemical manufacturing earn an average wage that is well above those in other manufacturing industries. Example: Entry-level process technicians earn $25,000 to $35,000 per year.

5. Seizing the Opportunity Advantages of working in this industry 3. Stable employment ● A rapidly growing industry increases both the demand and opportunities for skilled, competent professionals. ● Your knowledge is your unemployment insurance. ● Your mastery of process manufacturing technology is portable. ● If the particular company you work for downsizes, you are very likely to find a job in a different company.

6. Seizing the Opportunity Advantages of working in this industry 4. Modern and professional atmosphere ● High-tech, computer-controlled, efficient environments staffed by well-educated, professional technicians, engineers and scientists. ●Many companies use a team approach and encourage employees to assume higher levels of responsibility for problem solving.

7. Seizing the Opportunity Advantages of working in this industry 5. Safe working environments ●Because they are highly regulated by the government and required to follow very detailed good manufacturing practice (GMP), biotechnology, pharmaceutical and chemical companies provide a very safe place to work. ● One of the first things you will acquire on the job is thorough training in safety.

8. Seizing the Opportunity Advantages of working in this industry 6. Job variety and career advancement • Employees often have an opportunity for cross training or moving from one department to another. • As employees gain more experience, there also are opportunities for career advancement. • Employees can advance in managerial tracks, with more supervisory responsibility. • Employees may choose to advance within scientific or engineering specialty tracks.

9. Seizing the Opportunity Advantages of working in this industry 6. Job variety and career advancement • Biotechnology, pharmaceutical and chemical companies often have programs that reward employees for their knowledge and skills. • They reward employees for completing in-house training and formal academic education. • Many companies provide some tuition support for employees to attend college courses.

10. On the Job Educational options • Many educational options are available: • Two-year (associate or A.A.S.) degrees • Four-year (bachelor or B.S./B.A.) degrees • Certificate programs • Even for jobs requiring only a high school degree, companies rarely hire anyone straight out of high school. • Employers look for at least some additional college work, prior employment or military experience that demonstrates a certain level of maturity and commitment.

11. On the Job Entry-level positions are available • The good news — there are many different entry-level positions in biomanufacturing. • Entry-level jobs are ones that require a particular level of education but no prior work experience in the pharmaceutical or biopharmaceutical industries.

12. On the Job Job titles and descriptions • The job titles and brief descriptions listed on these slides illustrate the type of positions that exist in a generic biomanufacturing facility. • The actual organization of the various divisions, job titles and job descriptions vary from one company to another.

13. On the Job The job descriptions are grouped into five areas: 1. Production 2. Quality control (QC), quality assurance (QA) and validation 3. Manufacturing Support 4. Research and development (R&D) 5. Other divisions

14. 1. Production Positions Technicians • Positions include various technicians who work “on the floor” in the biomanufacturing facility. • These entry-level positions require a high school diploma, a process technician certificate or an A.A.S. degree, plus some “maturation time” after high school.

15. Production: Process technician Responsible for a variety of tasks involved in monitoring and control of manufacturing the product. Entry level; requires H.S. with experience, process technician certificate or A.A.S.

16. Responsible for washing, drying and sterilizing glassware. Production: Manufacturing prep process technician Entry level; requires H.S. with experience, process technician certificate, A.A.S.

17. Responsible for preparing the finished product from the purified active pharmaceutical or biopharmaceutical ingredients. Production: Formulation/fill technician Entry level; requires H.S. with experience, process technician certificate, A.A.S.

18. Uses packaging systems to label, inspect and package the finished product. Production: Packaging technician Entry level; requires H.S. with experience, process technician certificate, A.A.S.

19. Production: Process engineers These are entry-level positions requiring a four-year engineering degree — a bachelor of science (B.S.) in engineering.

20. Production: Process engineer in manufacturing ● Designs, develops and operates the current manufacturing process. ●Works with technicians to ensure that the product is manufactured properly. Entry level; requires a B.S. in engineering.

21. Production:Process engineer in process development Responsible for the design, scale-up and validation of new processes, from the laboratory, to pilot-plant stage, to large-scale manufacturing. Entry level; requires a B.S. in engineering.

22. 2. Quality control positions • Quality control (QC) involves checking the raw materials and product during every phase of its manufacture. • QC jobs include: • entry-level positions requiring an A.A.S. • entry-level positions requiring a B.A./B.S. • positions requiring B.A./B.S. plus industry experience.

23. QC: Quality control assistant Analyzes raw materials, in-process samples and finished formulations according to SOPs. Entry level; requires a two-year degree (A.A.S.).

24. QC: Quality control associate ●Coordinates activities needed to document good manufacturing practice (GMP) and to update SOPs. ●Reviews data obtained by the QC assistant and reports abnormalities. Entry level; requires a four-year degree (B.S. or B.A.).

25. QC: Quality control engineer • Develops, revises and maintains standards for converting raw materials into products. • Devises SOPs for testing procedures. Entry level; requires a B.S. in engineering.

26. QC: Process quality inspector Performs a wide variety of inspections, checks, tests and sampling procedures related to the manufacturing process. Position requires at least a four-year degree and job experience in the industry.

27. 2. Quality assurance positions • Quality assurance (QA) focuses on the overall system of manufacturing. • QA employees set up and check the standard operating procedures (SOPs) and documentation. • Their jobs ensure product quality and compliance with Good Manufacturing Practice (GMP) regulations. • These positions require a B.A./B.S.

28. QA: Quality assurance associate Writes and edits SOPs, laboratory procedures, manuals and other documents in a uniform style. Entry level; requires a four-year degree (B.S. or B.A.).

29. QA: Quality assurance auditor Performs audits of production and quality control to ensure compliance to in-house specification, standards and regulatory requirements. Position requires at least a four-year degree and job experience in the industry.

30. 2. Validation positions • Validation proves that an SOP will consistently produce the product with certain specifications when carried out exactly. • The operation of every part of the plant has to be validated. • Generally all validation positions require work experience in the industry.

31. 2. Validation positions ● Validation specialist (minimum A.A.S./B.S. degree) ● Validation engineer (minimum B.S. in engineering) ● Validation scientist (minimum B.S. in science)

32. Validation specialist, engineer and scientist • Responsible for ensuring a product is manufactured in accordance with regulations and in-house standards. • Validation engineers and scientists often have advanced degrees (M.S. or Ph.D.) and generally need extensive experience in the industry. • They must be thoroughly familiar with the FDA regulations and how to implement them.

33. 3. Manufacturing support • Maintenance of the plant and all of its utilities (electrical systems, water purification systems and heating, ventilation and air conditioning) • Management of waste products created during the manufacturing process • Many of these jobs are entry-level positions.

34. Manufacturing support: Instrumentation/calibration technician Responsible for calibrating, testing, troubleshooting, repairing and maintaining a variety of circuits, components, analytical equipment and instrumentation. Entry-level position requiring a H.S. diploma, A.AS. degree or specialized certification.

35. Manufacturing support technicians Manufacturing support technician • Maintains manufacturing equipment and solves production problems caused by machinery. Environmental technician • Performs routine environmental testing and carries out waste treatment operations. Entry-level positions requiring H.S. diploma, A.A.S. degree or specialized certification.

36. Manufacturing support engineers Maintenance engineer • Involved with maintenance and repairs of refrigeration, air conditioning, steam boilers, etc. Process control engineer • Designs and installs instruments to monitor and control certain manufacturing processes. Environmental engineer • Designs waste storage, treatment and recycling facilities. Entry-level positions requiring a four-year engineering degree (B.S.).

37. 4. Research and development (R&D) • These scientists generally work in labs that are not part of the manufacturing facility. • The educational requirements for these positions vary considerably. • Although many companies have entry-level positions, they greatly value experience in the industry.

38. R&D: Research assistant and associate Research assistant • Performs lab experiments and tests according to good laboratory practices under the direction of a research associate. Research associate • Seeks out new and more efficient ways to use and produce existing products. Entry-level positions requiring either a two- or four-year degree.

39. R&D: Research scientists in drug discovery • Work in a team in numerous areas • Identifying new drug targets • Creating animal models to test new drugs • Investigating the causes of and treatments for diseases. • Disciplines include: • chemistry • cell biology • molecular biology • biochemistry Entry-level positions requiring either a Ph.D. or an M.S. plus experience.

40. 5. Other divisions ● These employees may work in offices within the facility or at another location. ● The educational requirements vary according to the job. ● Companies value experience in the industry and often require it.

41. Other divisions:Customer support specialist • Responsible for ensuring delivery of product that meets the customers’ requirements. • May serve as a contact for customers with technical questions. • Requires a four-year degree and usually some industry experience. • May work in offices within the facility or in another location.

42. Other divisions:Clinical trials associate (CRA) • Assists in the monitoring and management of clinical trials. • Position requires knowledge of drug development, clinical research, federal regulations and good clinical practices. • Experience in the industry is highly desirable. Position requires a two-year or four-year degree and/or specialized certification.

43. Other divisions:Regulatory affairs specialist • Coordinates and prepares a variety of documents to submit to the FDA. • There is considerable opportunity for promotion, within the regulatory affairs department as well as moves into other departments. • The regulatory affairs associate usually is the entry-level position (although industry experience may be required). Position requires at least a B.A./B.S. and industry experience.