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