SPEAKER NAME SPEAKER TITLE SPEAKER COMPANY

1. Introduction to the Manufacturing Science and Engineering section of AAPS and Careers in the Pharmaceutical and Biotech Industries SPEAKER NAME SPEAKER TITLE SPEAKER COMPANY

2. Agenda Part I • AAPS Overview and Student Benefits • AAPS MSE section • MSE ambassador program Part II • Career Tips and Opportunities • Personal career perspective – Speaker name • Discussion Q&A

3. What is AAPS ? AAPS is the American Association of Pharmaceutical Scientists AAPS is a professional, scientific association of approximately 11,000 pharmaceutical scientists employed in industry, academia, government, and other research institutes worldwide. AAPS provides a dynamic international forum for the exchange of knowledge among scientists to enhance their contributions to health. AAPS offers timely scientific programs, ongoing education, opportunities for networking, and professional development.

4. What are Student Benefits • Visiting Scientist Program • Mentoring Events • Networking/Professional Development/Career network • Student Chapters • Communication (i.e. Awards/Travelships/Programming) • Student Reps to Sections and Committees • Annual meetings • Learning through Focus group(s) • eLearning, Webinars

5. Within AAPS you have the choice of 9 sections • APQ - Analysis and Pharmaceutical Quality section   • BIOTEC - Biotechnology section   • CPTR - Clinical Pharmacology and Translational Research section  • DDDI - Drug Discovery and Development Interface section   • FDD - Formulation Design and Development section   • MSE - Manufacturing Science and Engineering section • PPB - Physical Pharmacy and Biopharmaceutics section  • PPDM - Pharmacokinetics, Pharmacodynamics, and Drug Metabolism section  • RS - Regulatory Sciences section 

6. What is the MSE section all about? VisionThe MSE section will be recognized globally as the premier organization of individuals dedicated to the advancement of science and engineeringas applied to the design and manufacture of pharmaceutical products. Mission  • forum for interchange of scientific knowledge and technical advances related to efficient and robust design, implementation, and execution of the manufacture of pharmaceutical products. • foster graduate education, career growth, and professional development • recognize excellence and achievement of its members, encourage programming and publication of manufacturing-related scientific works by its members in AAPS-sponsored journals

7. What are MSE membership benefits? • MSE Newsletter • Travelships • Awards • Broaden Your Scientific Knowledge • Present Scientific Data • Expand Your Network • Participate as a Volunteer

9. MSE launches Ambassador Program This program is intended to • Raise awareness amongst students about MSE-related career opportunities, especially in industry • Create open communication channels between academia and MSE • Better-prepare new hires for industry • Role of MSE scientist/engineer in Pharma and Bio • Job expectations • Identify ways to enrich academic programs with industrial topics related to manufacturing

10. Agenda Part I • AAPS Overview and Student Benefits • AAPS MSE section • MSE ambassador program Part II • Career Tips and Opportunities • Personal career perspective – Speaker name • Discussion Q&A

11. What skills are most valued in the Pharma/Biotech Industry? • Scientific/Technical Excellence • Leadership and Responsibility • Teamwork and Communication • Acceptance of Challenges and Risks

12. MSE scientist/engineer Question: What is the ideal skill set ? Answer: What kind of a job ? What are my day-to-day responsibilities ?

13. Where do manufacturing scientists and engineers fit into the drug product development process? Late Development Early Development DRUG DISCOVERY PRODUCT LAUNCH Drug Discovery Biopharmaceutics Technical Operations Manufacturing

14. Drug Form Selection Drug Discovery Support Drug Characterization Toxicology Formulation IND Stability Phase I Clinical Formulation Biopharmaceutics R&D Functions in Early Phase Exploratory Pharm Applied Drug Delivery Technology

15. Consumer Need Biopharmaceutics R &D Functions in Advanced Phase Commercial Formulation Development Dosage Form Properties Powder Properties Pharmaceutics/ Biopharmaceutics Bioavailability Manufacturability Product Stability

16. MSE scientist skill set • Pharmaceutical aspects – Pharmacy courses • Pharmacokinetics • Physical pharmacy • Material properties – Material Science • API powder properties – size, morphology, form • Final product properties – flow, compaction • Formulation – Chemistry • Excipients • Chemical interactions, stability • Pharmaceutics

17. MSE scientist skill set • Process - Engineering • Pharmaceutical Unit operations • Engineering fundamentals, Scale-up • Granulation, powder mixing, compaction, coating • Modeling - Engineering • Minimize API use – cost savings • Enhance fundamental understanding • Design of experiments - Statistics • Statistical Design and data analysis

18. MSE scientist skill set • Technical writing • Development reports • NDA sections • Basic regulatory knowledge • Familiarity with ICH guidelines And further……… • Project management • Soft skills e.g. communication capability

19. MSE skill set • Education: • B.Sc./M.Sc. in Pharmaceutical Sciences, Chemistry, Biology, Biomedical Engineering, Chemical Engineering, Statistics, or related fields • Pharm.D. • Ph.D. in Pharmaceutical Sciences, Biochemistry, Biotechnology, Chemical Engineering, or related fields • Education doesn’t stop once you’ve ‘landed the job’ • Courses • Engineering principles • Chemistry and biochemistry • Pharmaceutical sciences • Research experience

21. Questions ?? MSE ambassador program contact: Preetanshu Pandey (Bristol-Myers Squibb) Bindhu Rayaprolu (PharmaForce Inc.) Sharmista Chatterjee (Food and Drug Administration) MSE section Stacey May - AAPS

22. Case Study Speaker name