Introduction to the Manufacturing Science and Engineering section of AAPS and Careers in the Pharmaceutical and Biotech Industries

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

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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.
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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

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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 

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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

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What are MSE membership benefits?

• MSE Newsletter
• Travelships
• Awards
• Broaden Your Scientific Knowledge
• Present Scientific Data
• Expand Your Network
• Participate as a Volunteer

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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

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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 QA

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What skills are most valued in the Pharma/Biotech
Industry?

• Scientific/Technical Excellence
• Leadership and Responsibility
• Teamwork and Communication
• Acceptance of Challenges and Risks

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MSE scientist/engineer

• Question
• What is the ideal skill set ?
• Answer
• What kind of a job ?
• What are my day-to-day responsibilities ?

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Where do manufacturing scientists and engineers
fit into the drug product development process?
Late Development
Early Development
PRODUCT LAUNCH
DRUG DISCOVERY
Drug Discovery
Biopharmaceutics
Technical Operations
Manufacturing
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Biopharmaceutics RD
Functions in Early Phase
Exploratory Pharm
Applied Drug Delivery Technology
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Biopharmaceutics R D
Functions in Advanced Phase
Commercial Formulation Development
Dosage Form Properties
Powder Properties
Pharmaceutics/ Biopharmaceutics
Bioavailability
Manufacturability
Product Stability
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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

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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

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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

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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 doesnt stop once youve landed the
  job
• Courses
• Engineering principles
• Chemistry and biochemistry
• Pharmaceutical sciences
• Research experience

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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

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Case Study

• Speaker name