Pharmaceutical Industry

Pharmaceutical Sector

PULLA RAOMail id: pullaraohrd@gmail.comLinkedin: http://in.linkedin.com/in/pullaraohrd

Industry overview

Pharmaceutical industry can be classified into four business units into two groups.

Group 1Drug 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

Time & CostDevelopment Stage Average time to

CompleteCost* % probability of

Success**Discovery 1 – 2 years $1 – 3 million 1%

Preclinical1. In vitro(Test tube) testing2. In vivo(animal) efficacy testing(1 – 2 animal models)3. Safety (toxicity) (2 animal models)Total pre-clinical

1 year1 – 2 years

1 – 2 years3 – 5 years

$1 million$1 – 2 million

$1 – 2 million$3 – 5 million

CMC (Chemistry, manufacturing and controls, which includes scale up) pre-clinical

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

$1 – 2 million 7%

IND****(Investigational New Drug) ( Preparation, filling and FDA approval)

3 – 6 years $0.5 – 1 million 10%

Clinicals1. Phase 1 (safety) studies2. Phase 2 (initial efficacy, small patient population)3. Phase 3 (comparative efficacy, larger patient population)Total clinical

1 – 2 years2 – 3 years

3 – 4 years

6 – 9 years

$10 – 20 million

$13 – 29 million

15 – 25%35 – 45%

CMC for NDA 1 – 2 years(can be run parallel with Phase 2 & Phase 3)

$2 – 4 million 70%

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

6 months to 1 year

1 – 2 years1.5 – 3 years

$1 – 2 million

FDA drug approval 12 – 21.5 years $23.5 – 48 million 100%

*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 MANUFACTURING

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 1. Production2. Quality Control3. Quality Assurance4. Process and development 5. Technology Transfer6. Process Engineering7. Engineering services

8. Projects9. Regulatory Affairs10.Supply chain management11.Ware house12.Business development and

strategic management13.Information Technology14.Finance15.Human Resources16.Administration17.Marketing

Generics It is the manufactures tablets,

capsules, oral drugs. API’s are further process in these

manufacturing. The functional department of the

business unit are 1. Production2. Quality Control3. Quality Assurance4. Process and development 5. Technology Transfer6. Process Engineering7. Engineering services

8. Projects9. Regulatory Affairs10.Supply chain management11.Ware house12.Business development and

strategic management13.Information Technology14.Finance15.Human Resources16.Administration17.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. Production2. Quality Control3. Quality Assurance4. Process and development 5. Technology Transfer6. Process Engineering7. Engineering services

8. Projects9. Regulatory Affairs10. Supply chain management11. Ware house12. Business development and strategic

management13. Information Technology14. Finance15. Human Resources16. Administration17. Marketing

Departments overview

FunctionEducational Qualification

API Generics Biologics

ProductionDiploma (Chemical)

B.Sc, M.Sc(chemistry)B.E(Chemical)

B. Pharm, M. PharmM. Sc(Biotechnology)M.Sc(Biochemistry)

B. Tech (Biotechnology)

Production Department

• Production department consists of 1. Chemists2. Shift Incharge3. Documentation expert4. Packing executive5. Process Engineer6. Production Manager7. Packing Manger8. 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

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 1. Q.C chemist2. QC Stability chemist3. QC Microbiologist4. 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

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

Process & development

M. Sc(Organic chemistry) M. Sc(Analytical

Chemistry)Ph.D(Chemistry)

B.E(Chemical)

M. PharmPh.D(Pharmaceutical

chemistry / Pharmaceutics)B.E(Chemical)

B.E(Biotechnology)M. Sc(Biotechnology)M.Sc(Biochemistry)

Ph.D(Biotechnology / Biochemistry)

Process Engineer

Process Engineering

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(Biotechnology)

Technology Transfer Team

Technology Transfer

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

orM.E. / M.Tech(Chemical)

M.PharmB.E / B.Tech (Chemical)

orM.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

Engineering services

ITI, diploma, B.E / B. Tech(Mechanical,

Electrical,Instrumentation),

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

Instrumentation)

• In engineering services department, employee are work at various levels in the following function.

1. Electrical technician( maintenance ) – Should be certified by electricity board2. Mechanical technician ( maintenance )3. Instrumentation technician ( maintenance )4. Electrical engineer5. Mechanical engineer6. Instrumentation engineer7. Civil engineer8. Utility maintenance9. Manger – Utilities10. Boiler operator – Should be certified boiler operator11. HVAC engineer12. 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

ITI, diploma, B.E / B. Tech(Mechanical, Electrical,

Instrumentation & Chemical),

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

M.E / M.Tech (Mechanical, Instrumentation &

Chemical)

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

• Usually there are two types of Projects in pharmaceuticals.1. Green field2. 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 find1. Instrumentation manger2. Civil engineer3. Mechanical engineer4. Chemical engineer5. Electrical engineer6. Project design engineer7. Project mangers8. Head – Project Management

Warehouse

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

Supply chain management

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

• SCM plays a crucial role in this industry with the following sub functions.1. Purchase – Corporate2. Purchase – Chemical3. Purchase – Material4. Purchase – Packing materials5. Purchase – Machines6. Logistics – Corporate7. Logistics – Chemical8. Logistics – Material9. Logistics – Packing materials10. Logistics – Machines11. Procurement12. Materials management13. Sourcing14. Head - Purchase15. Head – Logistics16. Head – Procurement17. Head – Sourcing18. Head - SCM

Business Development and Strategic management

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.1. Business Development Executive2. Business Development Manger3. Alliance Manager4. Manager – Third party manufacturing5. Project Manager6. Market research – Manager7. Market Analyst

Finance

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

• We usually find these designations…1. Head – Accounting2. Head – Finance3. Head – Audits4. Manager – Accounts5. Manager – Finance6. Manager – Audits7. Accounts Executive

Human Resources Management

Human Resources MBA(HR or OD or IR)

• We usually find these designations in HRD1. Head – HR2. Head – IR3. Head – Organisational Development4. Manager – HR5. Manager – IR6. Manager – OD7. Manager –Training and Development8. Head – Talent Acquisition9. Manager – Talent Acquisition Team10.Executive – Talent Management Team11.Executive – Talent Acquisition Team12.Executive- Training and Development13.Executive – Payroll

Information Technology

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

Administration 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

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

Marketing MBA(marketing, International Business)

Safety, Health and Environment

Safety Head and Environment

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 employees2. Employee referral3. Job portals (Naukri and Monster)4. Linkedin5. Vendors6. Head hunting7. 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 candidate

Educational Qualification Institute Work Experience Present

CompanyPervious

companies Present CTC Expected CTC

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.

Pharmaceutical Industry

productionquality

senior work

biotechnology

good knowledge

senior management

post graduate

functional

bio molecule

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