Pharmaceutical

Sector

PULLA RAO
Mail id: pullaraohrd@gmail.com
Linkedin: http://in.linkedin.com/in/pullaraohrd

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

Group 1

DRUG DISCOVERY

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.

Process

Time &
Cost Of the
Process

Development
Stage

Average time to
Complete

Cost*

Discovery
Preclinical
1. In vitro(Test tube)
testing
2. In vivo(animal) efficacy
testing(1 2 animal
models)
3. Safety (toxicity) (2
animal models)
Total pre-clinical
CMC (Chemistry,
manufacturing and
controls, which includes
scale up) pre-clinical
IND****
(Investigational New Drug)
( Preparation, filling and
FDA approval)
Clinicals
1. Phase 1 (safety) studies
2. Phase 2 (initial efficacy,
small patient population)
3. Phase 3 (comparative
efficacy, larger patient
population)
Total clinical
CMC for NDA

1 2 years

$1 3 million

1%

1 year
1 2 years

$1 million
$1 2 million

2%
3%

1 2 years
3 5 years

$1 2 million
$3 5 million

4%
5%

$1 2 million

7%

3 6 years

$0.5 1 million

10%

1 2 years
2 3 years

$1 3 million
$3 6 million

15 25%
35 45%

3 4 years

$10 20 million

65%

6 9 years

$13 29 million

65%

1 2 years(can be run parallel

with Phase 2 & Phase 3)
6 months to 1 year

$2 4 million

70%

$1 2 million

75%

1 2 years
1.5 3 years

$1 2 million
$2 4 million

75%

NDA(New Drug
Application) (preparation
and submission includes
pre NDA meeting with
FDA)

Time & Cost

1 2 years(can be run in
parallel to pre-clinical
studies)***

% probability of
Success**

*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
Business Development will be a MBA from a premier institute.

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

Group 2

MANUFACTURI
NG

Overview of the
departments
Active Pharmaceutical
Ingredients(API)
In this particular business unit
manufactures bulk drugs called
APIs
The raw materials used are
chemicals.
The functional department of the
business unit are
1. Production
2. Quality Control
3. Quality Assurance
4. Process and development
5. Technology Transfer
6. Process Engineering
7. Engineering services

8. Projects
9. Regulatory Affairs
10.Supply chain management
11.Ware house
12.Business development and
strategic management
13.Information Technology
14.Finance
15.Human Resources
16.Administration
17.Marketing

Generics
It is the manufactures tablets,
capsules, oral drugs.
APIs are further process in
these manufacturing.
The functional department of
the business unit are
1. Production
2. Quality Control
3. Quality Assurance
4. Process and development
5. Technology Transfer
6. Process Engineering
7. Engineering services

8. Projects
9. Regulatory Affairs
10.Supply chain management
11.Ware house
12.Business development and
strategic management
13.Information Technology
14.Finance
15.Human Resources
16.Administration
17.Marketing

Biologics
It
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
1. Production
2. Quality Control
3. Quality Assurance
4. Process and development
5. Technology Transfer
6. Process Engineering
7. Engineering services

8. Projects
9. Regulatory Affairs
10.Supply chain management
11.Ware house
12.Business development and
strategic management
13.Information Technology
14.Finance
15.Human Resources
16.Administration
17.Marketing

Departments overview
Production Department
Function

Educational Qualification
API

Production

Generics

Biologics

M.
Diploma (Chemical)
Sc(Biotechnology)
B.Sc,
B. Pharm, M. Pharm M.Sc(Biochemistry)
M.Sc(chemistry)
B. Tech
B.E(Chemical)
(Biotechnology)


1.
2.
3.
4.
5.
6.
7.
8.

Production department consists of

Chemists
Shift Incharge
Documentation expert
Packing executive
Process Engineer
Production Manager
Packing Manger
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

Educational Qualification
API

Quality
Control

M. Sc(Chemistry)

Generics

Biologics

M. Pharm

M.
Sc(Biotechnology)
M.Sc(Biochemistry)

1.
2.
3.
4.

Quality control team checks the quality of the drugs

manufactured.
Quality control team consists of
Q.C chemist
QC Stability chemist
QC Microbiologist
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
Assurance

Educational Qualification
API

Generics

Biologics

M. Sc(chemistry)

M. Pharm

M.Sc(Biotechnology)
M.Sc(Biochemistry)

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

Educational Qualification
Function
API

Process &
developm
ent

M. Sc(Organic
chemistry)
M. Sc(Analytical
Chemistry)
Ph.D(Chemistry)
B.E(Chemical)

Generics

Biologics

B.E(Biotechnology)
M. Pharm
M.
Ph.D(Pharmaceutical
Sc(Biotechnology)
chemistry /
M.Sc(Biochemistry)
Pharmaceutics)
Ph.D(Biotechnology
B.E(Chemical)
/ Biochemistry)

Process Engineer
Function

Process
Engineering

Educational Qualification
API
B.E / B.Tech
(Chemical) or
M.E. /
M.Tech(Chemical)

Generics

Biologics

B.E / B.Tech
B.E / B.Tech
(Chemical or
(Chemical) or
Biotechnology) or
M.E. /
M.E. /
M.Tech(Chemical) M.Tech(Biotechnolo
gy)

Technology Transfer Team

Functio
n
Technolo
gy
Transfer

Educational Qualification
API

Generics

Biologics

M.Sc(chemistry)
B.E / B.Tech
(Chemical) or
M.E. /
M.Tech(Chemical)

M.Pharm
B.E / B.Tech
(Chemical) or
M.E. /
M.Tech(Chemical)

M.Sc(Biotechnology /
Biochemistry)
B.E / B.Tech (Chemical or
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
Educational Qualification
Function
API

Engineering
services

Generics

Biologics

ITI, diploma, B.E / B. ITI, diploma, B.E / B. ITI, diploma, B.E / B.

Tech(Mechanical,
Tech(Mechanical,
Tech(Mechanical,
Electrical,
Electrical,
Electrical,
Instrumentation),
Instrumentation),
Instrumentation),
M.E/M.Tech
M.E/M.Tech
M.E/M.Tech
(Mechanical,
(Mechanical,
(Mechanical,
Electrical,
Electrical,
Electrical,
Instrumentation)
Instrumentation)
Instrumentation)

In engineering services department, employee are work at various levels in the

following function.
1. Electrical technician( maintenance ) Should be certified by electricity board
2. Mechanical technician ( maintenance )
3. Instrumentation technician ( maintenance )
4. Electrical engineer
5. Mechanical engineer
6. Instrumentation engineer
7. Civil engineer
8. Utility maintenance
9. Manger Utilities
10.Boiler operator Should be certified boiler operator
11.HVAC engineer
12.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
Functio
n

Project
s

Educational Qualification
API

Generics

Biologics

ITI, diploma, B.E / B.

Tech(Mechanical,
Electrical,
Instrumentation &
Chemical),
M.E / M.Tech
(Mechanical,
Instrumentation &
Chemical)

ITI, diploma, B.E / B.

Tech(Mechanical,
Electrical,
Instrumentation &
Chemical),
M.E / M.Tech
(Mechanical,
Instrumentation &
Chemical)

ITI, diploma, B.E / B.

Tech(Mechanical,
Electrical,
Instrumentation &
Chemical),
M.E / M.Tech
(Mechanical,
Instrumentation &
Chemical)


1.
2.

1.
2.
3.
4.
5.
6.
7.
8.

Usually there are two types of Projects in pharmaceuticals.

Green field
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
Instrumentation manger
Civil engineer
Mechanical engineer
Chemical engineer
Electrical engineer
Project design engineer
Project mangers
Head Project Management

Warehouse
Educational Qualification
Function
API

Ware house

Generics

Biologics

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

Educational Qualification
API

Generics

Biologics

B.Com, M. Com, MBA(marketing / materials management /

SCM)


1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.

SCM plays a crucial role in this industry with the following sub functions.
Purchase Corporate
Purchase Chemical
Purchase Material
Purchase Packing materials
Purchase Machines
Logistics Corporate
Logistics Chemical
Logistics Material
Logistics Packing materials
Logistics Machines
Procurement
Materials management
Sourcing
Head - Purchase
Head Logistics
Head Procurement
Head Sourcing
Head - SCM

Business Development and Strategic

management
Function
Business
development
and Strategic
management

Educational Qualification
API

Generics

Biologics

MBA(marketing, International Business, Strategic

Management)

1.
2.
3.
4.
5.
6.
7.

It plays a major role in contract manufacturing.

We usually come across these designations.
Business Development Executive
Business Development Manger
Alliance Manager
Manager Third party manufacturing
Project Manager
Market research Manager
Market Analyst

Finance

Function
Finance

Educational Qualification
API

Generics

Biologics

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


1.
2.
3.
4.
5.
6.
7.

We usually find these designations

Head Accounting
Head Finance
Head Audits
Manager Accounts
Manager Finance
Manager Audits
Accounts Executive

Human Resources Management

Function
Human
Resources

Educational Qualification
API

Generics
MBA(HR or OD or IR)

Biologics

 We usually find these designations in HRD

1. Head HR
2. Head IR
3. Head Organisational Development
4. Manager HR
5. Manager IR
6. Manager OD
7. Manager Training and Development
8. Head Talent Acquisition
9. Manager Talent Acquisition Team
10.Executive Talent Management Team
11.Executive Talent Acquisition Team
12.Executive- Training and Development
13.Executive Payroll

Information Technology
Function
Informatio
n
Technology

Educational Qualification
API

Generics

Biologics

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
Administrat
ion

Educational Qualification
API

Generics

Biologics

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
Regulatory
Affairs

Educational Qualification
API

Generics

Biologics

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

Educational Qualification
API

Generics

Biologics

MBA(marketing, International Business)

Safety, Health and Environment

Function
Safety
Head and
Environmen
t

Educational Qualification
API

Generics

Biologics

Any graduate or a post graduate in science or Pharm and a

certified professional in Safety, Health and Environment.

Recruitment Process

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
Preliminary Interviews Can be done through Telecon or video
conference.
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
Educational
candidate
Qualification

Institute

Work
Experience

Present
Company

Pervious
Present CTC
companies

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.