Introduction to the Manufacturing Science and Engineering

section of AAPS and Careers in the Pharmaceutical and Biotech Industries

Introduction to the Manufacturing Science and Engineering

section of AAPS and Careers in the Pharmaceutical and Biotech Industries

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AgendaPart 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

AgendaPart 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?

PRODUCTLAUNCH

DRUGDISCOVERY

Early Development Late Development

Functions in Early PhaseBiopharmaceutics R&D

Exploratory PharmApplied Drug Delivery

Technology

Functions in Advanced PhaseBiopharmaceutics R &D

Pharmaceutics/Biopharmaceutics

Commercial Formulation Development

Powder Properties

Bioavailability

Dosage Form Properties

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

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