2. 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.
4. 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.
9. Development Stage Average time to Cost* % probability of
Complete Success**
Discovery
Preclinical
Time & Cost
1 – 2 years $1 – 3 million 1%
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
includes pre – NDA meeting with
FDA) 1 – 2 years $1 – 2 million 75%
FDA Review 1.5 – 3 years $2 – 4 million
Total NDA process
10. *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
11. 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).
12. • 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.
13. • 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
15. 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. 1. Projects
The functional department of the 2. Regulatory Affairs
business unit are 3. Supply chain management
5. Production 4. Ware house
6. Quality Control 5. Business development and
7. Quality Assurance strategic management
8. Process and development 6. Information Technology
9. Technology Transfer 7. Finance
10.Process Engineering 8. Human Resources
11.Engineering services 9. Administration
10.Marketing
16. Generics
It is the manufactures tablets,
capsules, oral drugs. 1. Projects
API’s are further process in these 2. Regulatory Affairs
manufacturing. 3. Supply chain management
The functional department of the 4. Ware house
business unit are 5. Business development and
5. Production strategic management
6. Quality Control 6. Information Technology
7. Quality Assurance 7. Finance
8. Process and development 8. Human Resources
9. Technology Transfer 9. Administration
10.Process Engineering 10.Marketing
11.Engineering services
17. Biologics
It basically manufactures bio similar
products by using downstream process
and upstream process.
The raw material is it self bio molecule 1. Projects
used to produce same kind of bio 2. Regulatory Affairs
molecule.
3. Supply chain management
The functional department of the
4. Ware house
business unit are
5. Business development and strategic
5. Production
management
6. Quality Control
6. Information Technology
7. Quality Assurance
7. Finance
8. Process and development
8. Human Resources
9. Technology Transfer
9. Administration
10. Process Engineering
10. Marketing
11. Engineering services
18. Departments overview
Production Department
Educational Qualification
Function
API Generics Biologics
Diploma (Chemical) M. Sc(Biotechnology)
Production B.Sc, M.Sc(chemistry) B. Pharm, M. Pharm M.Sc(Biochemistry)
B.E(Chemical) B. Tech (Biotechnology)
19. • 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
20. Quality Control
Educational Qualification
Function
API Generics Biologics
M. Sc(Biotechnology)
Quality Control M. Sc(Chemistry) M. Pharm
M.Sc(Biochemistry)
21. • 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).
22. Quality Assurance
Educational Qualification
Function
API Generics Biologics
Quality M. Sc(chemistry) M. Pharm
M.Sc(Biotechnology)
M.Sc(Biochemistry)
Assurance
23. • 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.
24. Process & Development
Educational Qualification
Function
API Generics Biologics
M. Sc(Organic chemistry) B.E(Biotechnology)
M. Pharm
Process & M. Sc(Analytical M. Sc(Biotechnology)
Ph.D(Pharmaceutical
Chemistry) M.Sc(Biochemistry)
chemistry / Pharmaceutics)
development Ph.D(Chemistry)
B.E(Chemical)
Ph.D(Biotechnology /
B.E(Chemical) Biochemistry)
25. Process Engineer
Educational Qualification
Function
API Generics Biologics
B.E / B.Tech (Chemical
B.E / B.Tech (Chemical) B.E / B.Tech (Chemical)
Process or or
or Biotechnology) or
M.E. /
Engineering M.E. / M.Tech(Chemical) M.E. / M.Tech(Chemical)
M.Tech(Biotechnology)
26. Technology Transfer Team
Educational Qualification
Function
API Generics Biologics
M.Sc(Biotechnology /
M.Sc(chemistry) M.Pharm Biochemistry)
Technology B.E / B.Tech (Chemical) B.E / B.Tech (Chemical) B.E / B.Tech (Chemical or
or or Biotechnology) or
Transfer M.E. / M.Tech(Chemical) M.E. / M.Tech(Chemical) M.E. / M.Tech(Chemical or
Biotechnology)
27. • 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
28. Engineering Services
Educational Qualification
Function
API 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,
Engineering Instrumentation), Instrumentation), Instrumentation),
services M.E/M.Tech (Mechanical, M.E/M.Tech (Mechanical, M.E/M.Tech (Mechanical,
Electrical, Electrical, Electrical,
Instrumentation) Instrumentation) Instrumentation)
29. • 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.
31. • 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
32. Warehouse
Educational Qualification
Function
API Generics Biologics
Ware house B. Sc or B.Com and certified course in Materials management
33. • 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.
34. Supply chain Management
Educational Qualification
Function
API Generics Biologics
Supply chain B.Com, M. Com, MBA(marketing / materials management / SCM)
management
35. • 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
36. Business Development and Strategic
management
Educational Qualification
Function
API Generics Biologics
Business development
and Strategic MBA(marketing, International Business, Strategic Management)
management
37. • 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
38. Finance
Educational Qualification
Function
API Generics Biologics
Finance B.Com, M. Com, C.A, ICWA, MBA(Finance)
39. • 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
40. Human Resources Management
Educational Qualification
Function
API Generics Biologics
Human Resources MBA(HR or OD or IR)
41. • 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 Development
14.Executive – Payroll
42. Information Technology
Educational Qualification
Function
API Generics Biologics
Information Certified Networking professional, MES, SAP, JAVA professionals
Technology
43. • 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.
44. Administration
Educational Qualification
Function
API Generics Biologics
Any graduate or a post graduate with good knowledge on industrial
Administration compliance
45. • 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.
46. Regulatory Affairs
Educational Qualification
Function
API Generics Biologics
M.Sc or M.Pharm and a certified course in Regulatory Affairs and good
Regulatory knowledge on regulated global markets is very helpful. Regulatory Affairs
Affairs Certifications will be a value added.
47. Marketing
Educational Qualification
Function
API Generics Biologics
Marketing MBA(marketing, International Business)
48. Safety, Health and Environment
Educational Qualification
Function
API Generics Biologics
Safety Head and Any graduate or a post graduate in science or Pharm and a certified
professional in Safety, Health and Environment.
Environment
51. 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.
52. 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
53. 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.
54. 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.
55. • 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.
56. Skill matrix
• Skill matrix is very much useful in recruiting the candidates at the mid or
senior work level.
57. Name of the
Educational Present Pervious
candidate Institute Work Experience Present CTC Expected CTC
Qualification Company companies
Mr. X
Mr. Y
Mr. Z
