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TRANSCRIPT
On the Job
Careers in Biomanufacturing
Seizing the Opportunity
n Bioprocess, pharmaceutical and chemical
manufacturing jobs offer unique
opportunities and benefits.
n You will be working in a thriving industry.
n You will be working in an industry in which
skilled and competent employees are in
great demand.
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:
q increase food production, making it possible to
feed the world.
q reduce infant deaths and prevent childhood
diseases.
q relieve painful symptoms, fight disease and
save lives.
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.
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.
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.
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.
Seizing the Opportunity
Advantages of working in this industry
6. Job variety and career advancement
n Employees often have an opportunity for cross
training or moving from one department to
another.
n As employees gain more experience, there also
are opportunities for career advancement.
n Employees can advance in managerial tracks,
with more supervisory responsibility.
n Employees may choose to advance within
scientific or engineering specialty tracks.
Seizing the Opportunity
Advantages of working in this industry
6. Job variety and career advancement
n Biotechnology, pharmaceutical and chemical
companies often have programs that reward
employees for their knowledge and skills.
n They reward employees for completing in-house
training and formal academic education.
n Many companies provide some tuition support for
employees to attend college courses.
On the Job
Educational options
n Many educational options are available:
q Two-year (associate or A.A.S.) degrees
q Four-year (bachelor or B.S./B.A.) degrees
q Certificate programs
n Even for jobs requiring only a high school degree,
companies rarely hire anyone straight out of high
school.
n Employers look for at least some additional
college work, prior employment or military
experience that demonstrates a certain level of
maturity and commitment.
On the Job
Entry-level positions are available
n The good news — there are many different entry-
level positions in biomanufacturing.
n Entry-level jobs are ones that require a particular
level of education but no prior work experience in
the pharmaceutical or biopharmaceutical
industries.
On the Job
Job titles and descriptions
n The job titles and brief descriptions listed on these
slides illustrate the type of positions that exist in a
generic biomanufacturing facility.
n The actual organization of the various divisions,
job titles and job descriptions vary from one
company to another.
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
1. Production Positions
Technicians
n Positions include various technicians
who work “on the floor” in the
biomanufacturing facility.
n 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.
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.
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.
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.
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.
Production: Process engineers
These are entry-level positions requiring a
four-year engineering degree — a bachelor
of science (B.S.) in engineering.
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.
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.
2. Quality control positions
n Quality control (QC) involves checking
the raw materials and product during every
phase of its manufacture.
n QC jobs include:
q entry-level positions requiring an A.A.S.
q entry-level positions requiring a B.A./B.S.
q positions requiring B.A./B.S. plus industry
experience.
QC: Quality control assistant
Entry level; requires a two-year degree (A.A.S.).
Analyzes raw
materials, in-
process samples
and finished
formulations
according to
SOPs.
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.).
QC: Quality control engineer
n Develops, revises and
maintains standards for
converting raw
materials into products.
n Devises SOPs for
testing procedures.
Entry level; requires a B.S. in engineering.
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.
2. Quality assurance positions
n Quality assurance (QA) focuses on the
overall system of manufacturing.
n QA employees set up and check the
standard operating procedures (SOPs)
and documentation.
n Their jobs ensure product quality and
compliance with Good Manufacturing
Practice (GMP) regulations.
n These positions require a B.A./B.S.
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.).
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.
2. Validation positions
n Validation proves that an SOP will
consistently produce the product with
certain specifications when carried out
exactly.
n The operation of every part of the plant
has to be validated.
n Generally all validation positions require
work experience in the industry.
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)
Validation specialist, engineer and
scientist
n Responsible for ensuring a product is
manufactured in accordance with regulations
and in-house standards.
n Validation engineers and scientists often have
advanced degrees (M.S. or Ph.D.) and generally
need extensive experience in the industry.
n They must be thoroughly familiar with the FDA
regulations and how to implement them.
3. Manufacturing support
n Maintenance of the plant and all
of its utilities (electrical systems,
water purification systems and
heating, ventilation and air
conditioning)
n Management of waste products
created during the manufacturing
process
n Many of these jobs are entry-
level positions.
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.
Manufacturing support technicians
Manufacturing support technician
n Maintains manufacturing equipment and
solves production problems caused by
machinery.
Environmental technician
n Performs routine environmental testing
and carries out waste treatment
operations.
Entry-level positions requiring H.S. diploma, A.A.S. degree or specialized certification.
Manufacturing support engineers
Maintenance engineer
n Involved with maintenance and repairs of refrigeration, air conditioning, steam boilers, etc.
Process control engineer
n Designs and installs instruments to monitor and control certain manufacturing processes.
Environmental engineer
n Designs waste storage, treatment and recycling facilities.
Entry-level positions requiring a four-year engineering degree (B.S.).
4. Research and development (R&D)
n These scientists generally work in labs that are not part of the manufacturing facility.
n The educational requirements for these positions vary considerably.
n Although many companies have entry-level positions, they greatly value experience in the industry.
R&D: Research assistant and associate
Research assistant
n Performs lab experiments and tests according to good laboratory practices under the direction of a research associate.
Research associate
n Seeks out new and more efficient ways to use and produce existing products.
Entry-level positions requiring either a two- or four-year degree.
R&D: Research scientists
in drug discovery
n Work in a team in numerous areas q Identifying new drug targets
q Creating animal models to test new drugs
q Investigating the causes of and treatments for diseases.
n Disciplines include: q chemistry
q cell biology
q molecular biology
q biochemistry
Entry-level positions requiring either a Ph.D. or an M.S. plus experience.
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.
Other divisions:
Customer support specialist n Responsible for ensuring delivery of product that
meets the customers’ requirements.
n May serve as a contact for customers with technical questions.
n Requires a four-year degree and usually some industry experience.
n May work in offices within the facility or in another
location.
Other divisions:
Clinical trials associate (CRA)
n Assists in the monitoring and management of
clinical trials.
n Position requires knowledge of drug development,
clinical research, federal regulations and good
clinical practices.
n Experience in the industry is highly desirable.
Position requires a two-year or four-year degree and/or specialized certification.
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.