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

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

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. 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. What is AAPS ?

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

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

What is the MSE section all about? Vision The MSE section will be recognized globally as the premier organization of individuals dedicated to the advancement of science and engineering as 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

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

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

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

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

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

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

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

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

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

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

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

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

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

Case Study Speaker name