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 (RD)
• 5. Other divisions

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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
Production Manufacturing prep process
technician

• Responsible for washing, drying and sterilizing
  glassware.

Entry level requires H.S. with experience,
process technician certificate, A.A.S.
17
Production Formulation/fill technician

• Responsible for preparing the finished product
  from the purified active pharmaceutical or
  biopharmaceutical ingredients.

Entry level requires H.S. with experience,
process technician certificate, A.A.S.
18
Production Packaging technician

• Uses packaging systems to label, inspect and
  package the finished product.

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
ProductionProcess 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.

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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 (RD)

• 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
RD 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
RD 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 divisionsCustomer 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 divisionsClinical 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 divisionsRegulatory 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.