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.