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Pharmaceutical Industry

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Pharmaceutical Industry

  1. 1. Pharmaceutical SectorPULLA RAOMail id: pullaraohrd@gmail.comLinkedin: http://in.linkedin.com/in/pullaraohrd
  2. 2. Industry overviewPharmaceutical industry can be classified into four businessunits into two groups.Group 1Drug DiscoveryGroup 2 (Manufacturing)1. Active Pharmaceutical Ingredients(API)2. Generics.3.Biologics.
  3. 3. Group 1 DRUG DISCOVERY
  4. 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.
  5. 5. Process
  6. 6. Time & Cost Of the Process
  7. 7. Development Stage Average time to Cost* % probability of Complete Success**DiscoveryPreclinical 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-clinicalIND**** 3 – 6 years $0.5 – 1 million 10%(Investigational New Drug)( Preparation, filling and FDAapproval)Clinicals1. 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 submissionincludes pre – NDA meeting withFDA) 1 – 2 years $1 – 2 million 75%FDA Review 1.5 – 3 years $2 – 4 millionTotal NDA process
  8. 8. *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
  9. 9. 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).
  10. 10. • 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.
  11. 11. • 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
  12. 12. Group 2 MANUFACTURING
  13. 13. Overview of the departmentsActive 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 management5. Production 4. Ware house6. Quality Control 5. Business development and7. Quality Assurance strategic management8. Process and development 6. Information Technology9. Technology Transfer 7. Finance10.Process Engineering 8. Human Resources11.Engineering services 9. Administration 10.Marketing
  14. 14. 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 and5. Production strategic management6. Quality Control 6. Information Technology7. Quality Assurance 7. Finance8. Process and development 8. Human Resources9. Technology Transfer 9. Administration10.Process Engineering 10.Marketing11.Engineering services
  15. 15. 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 strategic5. Production management6. Quality Control 6. Information Technology7. Quality Assurance 7. Finance8. Process and development 8. Human Resources9. Technology Transfer 9. Administration10. Process Engineering 10. Marketing11. Engineering services
  16. 16. 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)
  17. 17. • Production department consists of2. Chemists3. Shift Incharge4. Documentation expert5. Packing executive6. Process Engineer7. Production Manager8. Packing Manger9. 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
  18. 18. Quality Control Educational Qualification Function API Generics Biologics M. Sc(Biotechnology)Quality Control M. Sc(Chemistry) M. Pharm M.Sc(Biochemistry)
  19. 19. • Quality control team checks the quality of the drugs manufactured.• Quality control team consists of3. Q.C chemist4. QC Stability chemist5. QC Microbiologist6. 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).
  20. 20. Quality Assurance Educational QualificationFunction API Generics Biologics Quality M. Sc(chemistry) M. Pharm M.Sc(Biotechnology) M.Sc(Biochemistry)Assurance
  21. 21. • 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.
  22. 22. 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)
  23. 23. 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)
  24. 24. Technology Transfer Team Educational QualificationFunction 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)
  25. 25. • 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
  26. 26. 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)
  27. 27. • In engineering services department, employee are work at various levels in the following function.2. Electrical technician( maintenance ) – Should be certified by electricity board3. Mechanical technician ( maintenance )4. Instrumentation technician ( maintenance )5. Electrical engineer6. Mechanical engineer7. Instrumentation engineer8. Civil engineer9. Utility maintenance10. Manger – Utilities11. Boiler operator – Should be certified boiler operator12. HVAC engineer13. 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.
  28. 28. Projects Educational QualificationFunction API Generics Biologics ITI, diploma, B.E / B. ITI, diploma, B.E / B. Tech(Mechanical, Electrical, ITI, diploma, B.E / B. Tech(Mechanical, Electrical, Tech(Mechanical, Electrical, Instrumentation & Chemical), Instrumentation & Instrumentation &Projects Chemical), Chemical), M.E / M.Tech (Mechanical, M.E / M.Tech (Mechanical, M.E / M.Tech (Mechanical, Instrumentation & Chemical) Instrumentation & Instrumentation & Chemical) Chemical)
  29. 29. • Usually there are two types of Projects in pharmaceuticals.2. Green field3. 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 find7. Instrumentation manger8. Civil engineer9. Mechanical engineer10. Chemical engineer11. Electrical engineer12. Project design engineer13. Project mangers14. Head – Project Management
  30. 30. Warehouse Educational Qualification Function API Generics BiologicsWare house B. Sc or B.Com and certified course in Materials management
  31. 31. • 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.
  32. 32. Supply chain Management Educational Qualification Function API Generics BiologicsSupply chain B.Com, M. Com, MBA(marketing / materials management / SCM)management
  33. 33. • SCM plays a crucial role in this industry with the following sub functions.2. Purchase – Corporate3. Purchase – Chemical4. Purchase – Material5. Purchase – Packing materials6. Purchase – Machines7. Logistics – Corporate8. Logistics – Chemical9. Logistics – Material10. Logistics – Packing materials11. Logistics – Machines12. Procurement13. Materials management14. Sourcing15. Head - Purchase16. Head – Logistics17. Head – Procurement18. Head – Sourcing19. Head - SCM
  34. 34. Business Development and Strategic management Educational Qualification Function API Generics BiologicsBusiness development and Strategic MBA(marketing, International Business, Strategic Management) management
  35. 35. • It plays a major role in contract manufacturing.• We usually come across these designations.3. Business Development Executive4. Business Development Manger5. Alliance Manager6. Manager – Third party manufacturing7. Project Manager8. Market research – Manager9. Market Analyst
  36. 36. Finance Educational QualificationFunction API Generics BiologicsFinance B.Com, M. Com, C.A, ICWA, MBA(Finance)
  37. 37. • We usually find these designations…2. Head – Accounting3. Head – Finance4. Head – Audits5. Manager – Accounts6. Manager – Finance7. Manager – Audits8. Accounts Executive
  38. 38. Human Resources Management Educational Qualification Function API Generics BiologicsHuman Resources MBA(HR or OD or IR)
  39. 39. • We usually find these designations in HRD2. Head – HR3. Head – IR4. Head – Organisational Development5. Manager – HR6. Manager – IR7. Manager – OD8. Manager –Training and Development9. Head – Talent Acquisition10.Manager – Talent Acquisition Team11.Executive – Talent Management Team12.Executive – Talent Acquisition Team13.Executive- Training and Development14.Executive – Payroll
  40. 40. Information Technology Educational Qualification Function API Generics BiologicsInformation Certified Networking professional, MES, SAP, JAVA professionalsTechnology
  41. 41. • 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.
  42. 42. Administration Educational Qualification Function API Generics Biologics Any graduate or a post graduate with good knowledge on industrialAdministration compliance
  43. 43. • 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.
  44. 44. Regulatory Affairs Educational Qualification Function API Generics Biologics M.Sc or M.Pharm and a certified course in Regulatory Affairs and goodRegulatory knowledge on regulated global markets is very helpful. Regulatory Affairs Affairs Certifications will be a value added.
  45. 45. Marketing Educational QualificationFunction API Generics BiologicsMarketing MBA(marketing, International Business)
  46. 46. Safety, Health and Environment Educational Qualification Function API Generics BiologicsSafety Head and Any graduate or a post graduate in science or Pharm and a certified professional in Safety, Health and Environment. Environment
  47. 47. Recruitment Process
  48. 48. 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.
  49. 49. 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
  50. 50. 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.
  51. 51. 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.
  52. 52. • 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.
  53. 53. Skill matrix• Skill matrix is very much useful in recruiting the candidates at the mid or senior work level.
  54. 54. Name of the Educational Present Pervious candidate Institute Work Experience Present CTC Expected CTC Qualification Company companies Mr. X Mr. Y Mr. Z
  55. 55. IS THIS SUFFICIENT TO JUDGE ONTHE BEST FEASIBLE CANDIDATES???
  56. 56. Reasons are…• We need to check on the internal parity.• About his repotees work experience and their qualification.

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