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
  productneed understanding of infection control
  and the use of PPEs.

What PPEs are being used?
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.updates steps to the occupation manual
  frequently
• ? 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)

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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.performs
  maintenance checks on computers, equipment, etc

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
All monitor machine / computerized equipment for
problems

• 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.