Introduction to Pharmaceuticak Industry.pptx

Pharmaceutical Sector
Introduction
Dr.Gurumeet C Wadhawa ,Assistant Professor,
Department of Chemistry.
Rayat Shikshan sansthas Veer Wajekar ASC
College,Phunde,Uran

Industry overview
Pharmaceutical industry can
be classified units
into two groups.
into four
business
Group 1
Drug Discovery
Group 2 (Manufacturing)
1. Active Pharmaceutical
Ingredients(API)
2.Generic
s.
3.Biologic

Introduction
• The success of pharmaceutical companies is
completely depends on drug discovery.
• It involved great amount of time and money.
• The highly successful companies have a
great teams dedicated for R&D, who are
continuously keeping their efforts to build
and develop new molecules or medicines.
• It is a CATALYST of Pharmaceutical
Industry.

Tim
e
& Cost
Development
Stage
Average time
to
Complete
Cost* % probability
of
Success**
Discovery 1 – 2 years $1 – 3 million 1%
Preclinical
1. In vitro(Test tube) testing 1 year $1 million 2%
2. In vivo(animal) efficacy
testing(1 –
1 – 2 years $1 – 2 million 3%
2 animal models)
3. Safety (toxicity) (2 animal
models)
1 – 2 years $1 – 2 million 4%
Total pre-clinical 3 – 5 years $3 – 5 million 5%
CMC (Chemistry, manufacturing
and
1 – 2 years(can be run in parallel to $1 – 2 million 7%
controls, which includes scale
up)
pre-clinical studies)***
pre-clinical
IND**** 3 – 6 years $0.5 – 1 million 10%
(Investigational New Drug)
( Preparation, filling and FDA
approval)
Clinicals
1. Phase 1 (safety) studies 1 – 2 years $1 – 3 million 15 – 25%
2. Phase 2 (initial efficacy, small 2 – 3 years $3 – 6 million 35 – 45%
patient population)
3. Phase 3 (comparative efficacy, 3 – 4 years $10 – 20 million 65%
larger patient population)
Total clinical 6 – 9 years $13 – 29 million 65%
CMC for NDA 1 – 2 years(can be run parallel with $2 – 4 million 70%
Phase 2 & Phase 3)
NDA(New Drug Application) 6 months to 1 year $1 – 2 million 75%
(preparation and submission

*Cost for a biotech company; for a big pharma drug it might be the
factor of 5
**Of drug reaching the marketplace
*** If formulation changes, new preclinical studies may be needed
****Permission to begin testing in humans

Wanted leaders…
• Companies are looking for highly qualified quality professionals in the
area of Research and Development.
In India there are so many companies works on their internal drug
discovery and also takes care of projects for other companies.
Usual hierarchy is as follows:
Analyst reports to Scientist; Scientist reports to Sr. Scientist; Sr.
Scientist reports to Group leader and report to head of the
Department and HoD reports to Head(R&D).
•
•

•
•
Head (Research and Development) will be a Ph.D
Group leader or Head (Analytical research and Development,
Process Development, Formulation Research and
Development) will be a Ph.D
Development Quality Assurance
•
• Scientists (Analytical Research and Development, Process
Development, Formulation research and development, Cell culture
development, Bioassay development, Immunogenicity, PK &PD,
Microbiology, Protein Purification, Product characterization) will be a
M.Sc or Ph.D
PDF will be a Ph.D
Research Chemists will be a M.Sc
Process Engineer will be a B.E(Chemical or
Biotech) Project Mangers will be either Ph.D
or a MBA
•
•
•
•
•

•
•
• Head - Clinical Research and Development will be MBBS, MD and Ph.D
• Clinical Development Scientist will be MBBS, MD
• Project Manager - Clinical Trials will be MBBS, MD
• Clinical Investigators will be MBBS or MD
• CRA can be any science Post Graduate and certified professional
• CRC can be any science Post Graduate
• Clinical Operations Manager will be MBBS, MD
• Pharmacovigilance Manager will be MBBS, MD
• Medical Monitor will be MBBS, MD
• Medical Advisor will be MBBS, MD
• Medical Writer will be MBBS, MD
• Scientific writer will be MBBS, MD or M.Pharm, Ph.D
• Clinical Data Manager MBBS or any post graduate in Science or Pharma with a
certified professional
Biostatistician Manager any post graduate in Science or Pharma with a certified
professional SAS Programmer certified SAS professional

Overview of the departments
Active Pharmaceutical
Ingredients(API)
In this particular business unit
manufactures bulk drugs called
API’s
The raw materials used are
chemicals.
The functional department of
the business unit are
5. Production
6. Quality Control
7. Quality Assurance
8. Process and development
9. Technology Transfer
10.Process Engineering
1. Projects
2. Regulatory Affairs
3. Supply chain
management
4. Ware house
5. Business development
and strategic
management
6. Information Technology
7. Finance
8. Human Resources
9.Administration

Generi
cs
It is the manufactures
tablets, capsules, oral
drugs.
API’s are further process in
these manufacturing.
The functional department of
the business unit are
5. Production
6. Quality Control
8. Process and development
1. Projects
3. Supply chain
management
4. Ware house
5. Business development
and strategic
management
7. Finance
8. Human Resources
9.Administration

Biologi
csIt basically manufactures bio similar
products by using downstream
process and upstream process.
The raw material is it self bio
molecule used to produce same kind
of bio molecule.
The functional department of the
business unit are
5. Production
6. Quality Control
8. Process and
development
1. Projects
3. Supply chain management
4. Ware house
5. Business development and
strategic management
7. Finance
8. Human Resources
9. Administration
10.Marketing

Departments overview
Function
Educational Qualification
API Generics Biologics
Production
Diploma (Chemical)
B.Sc,
M.Sc(chemistry)
B.E(Chemical)
B. Pharm, M. Pharm
M.
Sc(Biotechnology)
M.Sc(Biochemistry
)
B. Tech
(Biotechnology)
Production Department

•
•
•
•
•
•
Production department consists of
2. Chemists
3. Shift Incharge
4. Documentation expert
5. Packing executive
6. Process Engineer
7. Production Manager
8. Packing Manger
9. Production Head
Skills matrix and accountability will vary for each work level.
Documentation expert requires good knowledge on chemistry and
computers. Chemist can be a science graduate.
From Shift Incharge to Production Manager should be a post graduate.
Production Head might be a Post graduate in Science or Pharmacy/ B.E
(chemical) / Ph.D

Quality Control
Function
Quality
Control
M. Sc(Chemistry) M. Pharm
M.
Sc(Biotechnology)
M.Sc(Biochemistry
)

•
•
•
•
•
Quality control team checks the quality of the drugs
manufactured. Quality control team consists of
3. Q.C chemist
4. QC Stability chemist
5. QC Microbiologist
6. QC Manger
QC team should be a post graduate in the area of Science,
Pharmacy, Biotechnology, Biochemistry and Microbiology.
At Senior Management, its preferable to have Ph.D and some
certified Quality Management professional.
At present, companies are looking for the highly
professionals to implement Quality by Design(QbD).

Quality Assurance
Function
Quality
Assuran
ce
M. Sc(chemistry) M. Pharm
M.Sc(Biotechnolog
y)
M.Sc(Biochemistr
y)

•
•
•
•
•
•
Quality Assurance team will define the quality of the
drug. It defines Standard operating
procedures(SOP).
Reviewing of batch production
records(BPR) QA has to approve the
quality of the drug.
It required good knowledge on GMP guidelines.
QC team should be a post graduate in the area of Science,
Pharmacy, Biotechnology, Biochemistry and Microbiology.
At Senior Management, its preferable to have Ph.D and some
certified Quality Management professional.
•

Process & Development
Function
Process
&
developme
nt
M. Sc(Organic
chemistry)
M.
Sc(Analytic
al
Chemistry)
Ph.D(Chemistr
y)
B.E(Chemical
)
M. Pharm
Ph.D(Pharmaceuti
cal
chemistry /
Pharmaceutics)
B.E(Chemical)
B.E(Biotechnology)
M.
Sc(Biotechnology)
M.Sc(Biochemistry)
Ph.D(Biotechnolog
y /
Biochemistry)

Process Engineer
Function
Process
Engineeri
ng
B.E / B.Tech
(Chemical)
or
M.E. /
M.Tech(Chemical)
B.E / B.Tech
(Chemical)
or
M.E. /
M.Tech(Chemical)
B.E / B.Tech
(Chemical or
Biotechnology) or
M.E. /
M.Tech(Biotechnolog
y)

Technology Transfer Team
Functio
n
M.Sc(Biotechnology /
Technolog
y
M.Sc(chemistry)
B.E / B.Tech
(Chemical)
M.Pharm
B.E / B.Tech
(Chemical)
Biochemistry)
B.E / B.Tech (Chemical or
Transfer or
M.E. /
M.Tech(Chemical)
or
M.E. /
M.Tech(Chemical)
Biotechnology) or
M.E. / M.Tech(Chemical or
Biotechnology)

• Process development, Process engineering, Technology transfer
teams work together to deliver the good quality of the product.
Process development team will define the process of manufacturing in
large scale, process engineering teams will ensure the process go
smooth and take care of troubleshooting when required, technology
transfer team take care of developing the process from lab scale to
plant scale.
In labs scientists can manufacture in milligrams or in grams.
Technology transfer teams manufacture at pilot scale i.e.,
kilograms by ensuring the quality is maintained throughout the
process.
In middle level companies may look for chemical / Biotech engineers or
a post graduate in Science / Pharm / Biotech.
At Senior management level, its preferred to have a Ph.D
•
•
•
•
•

Engineering Services
Function
Engineeri
ng
services
ITI, diploma, B.E / B.
Tech(Mechanical,
Electrical,
Instrumentation),
M.E/M.Tech
(Mechanical, Electrical,
Instrumentation)
Tech(Mechanical,
Electrical,
Instrumentation),
M.E/M.Tech
Instrumentation)
Tech(Mechanical,
Electrical,
Instrumentation),
M.E/M.Tech
Instrumentation)

• In engineering services department, employee are work at various levels in the
following function.
2. Electrical technician( maintenance ) – Should be certified by electricity board
3. Mechanical technician ( maintenance )
4. Instrumentation technician ( maintenance )
5. Electrical engineer
6. Mechanical engineer
7. Instrumentation engineer
8. Civil engineer
9. Utility maintenance
10. Manger – Utilities
11. Boiler operator – Should be certified boiler
operator
12. HVAC engineer
13. Head - Engineering
•
•
At technician work level, companies looking for ITI or Diploma in the respective
streams
B.E / B.Tech comes at supervisor, engineer, managerial work levels.

Projects
Chemica
l)
Functio
n
Project
s
Tech(Mechanical,
Electrical, Instrumentation
& Chemical),
M.E / M.Tech
(Mechanical,
Instrumentation &
Chemical)
Tech(Mechanical,
Electrical,
Instrumentation
& Chemical),
M.E / M.Tech
(Mechanical,
Instrumentation &
Tech(Mechanical,
Electrical,
Instrumentation &
Chemical),
M.E / M.Tech
(Mechanical,
Instrumentation &
Chemical)

• Usually there are two types of Projects in pharmaceuticals.
2. Green field
3. White field
• Green field projects will start from scratch to operations
• White field projects are the modified projects of the existing
projects.
• The following position we majorly find
7. Instrumentation manger
8. Civil engineer
9. Mechanical engineer
10.Chemical engineer
11.Electrical engineer
12.Project design engineer
13.Project mangers
14.Head – Project
Management

Warehouse
Function
Ware house B. Sc or B.Com and certified course in Materials management

• In Pharmaceutical industry, the specifications in warehouse
department is keep changing.
Earlier, companies hire any graduate or a commerce graduate.
At present scenario, companies looking for science graduate, as
they will have a exposure on chemical properties and warehouse to
be maintained properly.
At senior work levels, companies looking for a candidates
with a certification on Materials management.
They will report to SCM department.
•
•
•
•

Supply chain Management
Function
Supply
chain
manageme
nt
B.Com, M. Com, MBA(marketing / materials management /
SCM)

• SCM plays a crucial role in this industry with the following sub
functions.
2. Purchase – Corporate
3. Purchase – Chemical
4. Purchase – Material
5. Purchase – Packing materials
6. Purchase – Machines
7. Logistics – Corporate
8. Logistics – Chemical
9. Logistics – Material
10. Logistics – Packing materials
11. Logistics – Machines
12. Procurement
13. Materials management
14. Sourcing
15. Head - Purchase
16. Head – Logistics
17. Head – Procurement
18. Head – Sourcing
19. Head - SCM

Business Development and Strategic
management
Function
Business
development
and Strategic
management
MBA(marketing, International Business, Strategic
Management)

•
•
It plays a major role in contract
manufacturing. We usually come across
these designations.
3. Business Development Executive
4. Business Development Manger
5. Alliance Manager
6. Manager – Third party manufacturing
7. Project Manager
8. Market research – Manager
9. Market Analyst

Finance
Function
Finance B.Com, M. Com, C.A, ICWA, MBA(Finance)

• We usually find these
designations…
2. Head – Accounting
3. Head – Finance
4. Head – Audits
5. Manager – Accounts
6. Manager – Finance
7. Manager – Audits
8. Accounts Executive

Human Resources Management
Function
Human
Resources
MBA(HR or OD or IR)

• We usually find these designations in
HRD
2. Head – HR
3. Head – IR
4. Head – Organisational Development
5. Manager – HR
6. Manager – IR
7. Manager – OD
8. Manager –Training and Development
9. Head – Talent Acquisition
10.Manager – Talent Acquisition Team
11.Executive – Talent Management
Team
12.Executive – Talent Acquisition
Team
13.Executive- Training and

Information Technology
Function
Informatio
n
Technolo
gy
Certified Networking professional, MES, SAP, JAVA
professionals

•
•
•
•
•
•
Its very critical department in the Pharmaceutical
sector. Usually all the documents are maintained
online.
Most of the machines are automated with DCS, PLC, SCADA
and MES. Majorly we can find the following designations.
Manager – IT
SAP professionals with the expertise in Production Planning, MM,
SCM, HR and all major functions.
Network support administrators – usually certified professionals
are required.
•

Administration
Function
Administratio
n
Any graduate or a post graduate with good knowledge on
industrial compliance

•
•
Administrative department plays a key role in day to day
activities.
Companies looking for very highly energetic, networking
good communicator for the various positions in admin
team.
Some companies prefers candidates from Ex – Defense services.
Admin need to communicate with various parties both inside and
outside company.
Should have strong knowledge on industrial compliances.
•
•
•

Regulatory Affairs
Function
Regulato
ry
Affairs
M.Sc or M.Pharm and a certified course in Regulatory Affairs and
good knowledge on regulated global markets is very helpful.
Regulatory Affairs Certifications will be a value added.

Marketing
Function
Marketing MBA(marketing, International Business)

Safety, Health and Environment
Function
Safety Head
and
Environment
Any graduate or a post graduate in science or Pharm and a
certified professional in Safety, Health and
Environment.

Planning(structure, focus, prepare and Identify)
Structure – Need to understand the Key
responsibility areas of the position
which we are going to hire a candidate.
Need to concentrate on the job description, key results
area, opportunities, career implication, salary and benefits.
Focus – Recruiter need to focus on the quality of candidates,
sourcing mix in order to meet the requirements of a the requisition.
Prepare – Recruiter need to prepare the sourcing mix.
Indentify – With the using of sourcing mix, recruiter need to
indentify the most possible fit candidates.

What is sourcing mix
•
•
It is the strategy to find the candidates who are fit to the
requirement. We can source profiles form
1. Internal employees
2. Employee referral
3. Job portals (Naukri and Monster)
4. Linkedin
5. Vendors
6. Head hunting
7. Advertising on print media

Implementation(contact and evaluate)
•
•
•
Contact - Recruiter need to source the profiles which are matching
to the requirements.
Initial screening can be done by him/her.
Another screening of the profiles can be done by technical panel.
Evaluate
• Preliminar
y
conferenc
e.
Interviews – Can be done through Telecon or
video
•
• If the candidate is found suitable, final interviews can be done
through Video conference(for junior profiles) or by personal
interviews(must for mid level and senior level).
Reference Check or Background verification– Is to be done. It
can be before joining of the candidate or after joining of the
candidate.

Closure(select, offer & joining)
• Select – after all the evaluations are done, the technical team and the HR has to
decide on the candidate selection.
Offer – Recruiter need to prepare like to like of presently what he is. And what we
can offer. HR will decide on the CTC to be offered.
After receiving the inputs from HR, recruiter need to have a clear discussion with the
candidate about the offer to be made and send a official mail of offer.
Candidate has to reply back on the mail by next 24 hours of his acceptance.
If he is not replying back by next 72 hours, recruiter has to have a conversation with
the candidate, need to take his concerns about the offer and request to write him with
his concerns.
If the concerns can be considered, recruiter need to have a discussion with the HR
and clear it off.
If concerns are not with in the boundaries, recruiter has to revote the
offer. Recruiter should be in continuous follow up with the candidate till
his joining.
•
•
•
•
•
•
•
•

• We can find the profiles of the junior work level in Job sites like
Naukri and monster.
For middle level along with job sites linkedin is very helpful for
getting the closures.
Especially at the top management we can use linkedin and need to
headhunt for the leaders in the industry.
Internal employee referrals is also very much useful for getting
closures. Communication skills and basic computer knowledge is
must.
Vendor management is very much helpful for recruitments candidates and
middle and senior work levels.
A recruiter should have accurate understanding on the
requirement. It will help him to close the positions in time.
Continuous interactions with the line managers will help a recruiter to
understand what exactly he is looking at his team.
•
•
•
•
•
•
•
•

Skill matrix
• Skill matrix is very much useful in recruiting the candidates at the
mid or senior work level.

Name of
the
candidate
Education
al
Qualificatio
n
Institute Work
Experience
Presen
t
Compa
ny
Perviou
s
compani
es
Present CTC Expected
CTC
Mr. X
Mr. Y
Mr. Z

IS THIS SUFFICIENT TO JUDGE ON
THE BEST FEASIBLE CANDIDATES???

Reasons are…
•
•
We need to check on the internal parity.
About his repotees work experience and their
qualification.

Introduction to Pharmaceuticak Industry.pptx

Introduction to Pharmaceuticak Industry.pptx

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