Biocon-KGI Certificate Program in Biosciences

Adding Value, Enhancing Skills
Biocon-KGI Certificate
Program in Biosciences
Designed to enhance your employability in
the Biotech Industry
Biocon Academy's flagship program - the Biocon-KGI Certificate Program in Biosciences is an industry oriented program that
transforms graduate and post graduate students into professionals, ready to take on the evolving challenges of the biotech industry.
Why should you join the program?
The 16 week industry oriented Biocon-KGI Certificate Program in Biosciences, delivered by
Admissions
renowned faculty from Biocon Academy and KGI, encompasses training in R&D, production as per
GMP, quality assurance, regulatory, product development and professional skills to provide students
an in-depth understanding of technology and regulations.
This program enables:
Admissions for the 2014 batch of
Biocon-KGI Certificate Program
in Biosciences is now open!
If you are interested in leading the future
Learning from internationally
recognized experts
Development of job-skills
through practical exposure
Face-to-face interaction with renowned
subject matter experts from Biocon,
industry and academia
Thrice a week functional visit to
Biocon facilities with assignments from
KGI on Quality, R&D and Regulatory
Mentorship by the industry and
experienced faculty from KGI and
Biocon Academy
Post classroom session and GMP
training
of Biosciences, submit your application for
the program before December 6, 2013.
Visit www.bioconacademy.com
Education Partner
3 hours of KGI Lessons + 1 hour
classroom assignments on daily basis
Professional skills development and
personal grooming through weekly
training sessions
For details on the eligibility, course curriculum and scholarship, please turn overleaf.
For more information, visit www.bioconacademy.com
Who can join the program?
Biocon Scholarship
Educational Qualification:
BE/B.Tech in Biotechnology/Industrial Biotechnology
MSc. in Biotechnology /Microbiology/ Biochemistry/ Biology
B.Pharm
75%
of the program fee to all
selected students.
Program Fee - INR 6,00,000
CGPA: 7.5 (71 percentage) and above
Student’s Share - INR 1,50,000
Break in career: 1 year and less from HSC/PUC to the current highest degree
Job Opportunity
Course Curriculum
The program has three major components - Technical Course modules,
Professional Skills module and Industry-Academy interactions.
The course modules are selected carefully to meet the objective of transforming our
students to industry-ready professionals. The modules offered include:
Course Name
Course Code
Molecular Biotechnology
ALS 300
Biopharmaceutical Quality Assurance and Control
ALS 418
Introduction to US FDA and European Laws and Regulations
ALS 462
Bioseparation Engineering and Science
ALS 429
Pharmaceutical Development
ALS 333
CMC Regulations of Pharmaceuticals
ALS 419
Fermentation Principles - Module I
ALS 427A
Mammalian Cell Biotechnology - Module II
ALS 427B
at Biocon Ltd and other leading
Biotech companies
For more details on
Biocon-KGI Certificate
Program in Biosciences
Visit:
www.bioconacademy.com
Call:
+91 80 6775 1868
E-mail: admissions@bioconacademy.com
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latest updates
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Professional Skills Development
linkedin.com/company
/bioconacademy
For more information, visit www.bioconacademy.com
Adding Value, Enhancing Skills
Faculty at
Biocon Academy
The Experts who develop the
Bioscientists of tomorrow
SS.Easwaran
Faculty for Functional Projects
Academic Director, Biocon-KGI Certificate Program in Biosciences
Qualification:
M.Sc., Microbiology | M.Phil, Life Sciences | GCP Certification | PG Dip. Marketing Management | MDP
SS.Easwaran is the Academic Director at Biocon Academy, Bangalore where he is responsible for executing Biocon-KGI
Certificate Program in Biosciences. Prior to joining Biocon Academy, he was General Manager for Technology and
Services, BIOZEEN, responsible for the Biopharmaceutical Production Training and Regulatory Services departments.
Meghana Joshi
Courses
333 - Pharmaceutical Development
Program Director and Faculty for the Biocon-KGI Certificate Program in Biosciences
Qualification: PhD, Biological Sciences | PPM
Dr. Meghana Joshi is the Program Director for Biocon-KGI certificate program in Biosciences based at KGI, California,
USA. Dr. Joshi has a strong foundation in Biopharmaceutical Business Development with a strong focus on emerging
markets as well and over 5 years of Biotech research experience. Dr. Joshi has held lead positions in organizations for
strategy and marketing decisions and process improvement with cross-functional teams globally.
Dr. Joshi received her PhD in Biological Sciences from the University of Illinois at Chicago, followed by post-doctoral
experience at M.D.Anderson Cancer Center, Houston, Texas and Columbia University, New York. Prior to her doctoral
work, she was an active business partner in Saraswati Agencies in Mumbai. Thereafter, she completed the KGI Post
Doctoral Professional Masters Degree, a program training PhD’s to work in the Biotech industry.
For more information, visit www.bioconacademy.com
Adding Value, Enhancing Skills
Faculty at
Biocon Academy
The Experts who develop the
Bioscientists of tomorrow
Susan Bain
Professor KGI
Courses
418 - Biopharmaceutical Quality Assurance and Control
462 - Introduction to US FDA and European Laws and Regulations
419 - CMC Regulations of Pharmaceuticals
Qualification: DRSc
Dr. Bain has a strong background in Regulatory Affairs, Quality Assurance, Compliance and Operations, with more than
25 years of managerial experience at leading pharmaceutical, biotech and medical device firms, as well as at the FDA.
Her corporate experience includes serving as a Vice President in-charge of Quality/Regulatory Assurance and Operations
at the Huntington Beach-based SpineWorks LLC, a medical device company which focuses on implant design and
development, assisting people with complex spine conditions. Prior to that, she was the Manager of Regulatory Affairs
and then the Manager of Corporate Quality Assurance at Watson Pharmaceuticals in Corona, CA.
Dr. Bain has a Doctorate in Regulatory Science from the University of Southern California.
Anastasia Levitin
Courses
300 - Molecular Biotechnology
Assistant Professor, KGI
Qualification: PhD
Dr. Levitin received her undergraduate degree in Biochemistry and her PhD in Biology at Concordia University,
Montreal, Canada. Her postdoctoral studies were done at National Research Council of Canada and at Stanford
University School of Medicine.
Dr. Levitin is interested in studying host immune response to bacterial/fungal infections and defining biomarkers for
rapid detection of microbial infection, as well as developing vaccines for prevention of infection. As a FDA Consumer
Safety Officer based in Irvine, she investigated complaints against FDA-regulated products, conducted audit recall
checks and monitored compliance to injunctions and seizures.
For more information, visit www.bioconacademy.com
Adding Value, Enhancing Skills
Faculty at
Biocon Academy
The Experts who develop the
Bioscientists of tomorrow
Michael Jamieson
Adjunct Professor, KGI
Courses
462 - Introduction to US FDA and European Laws and Regulations
419 - CMC Regulations of Pharmaceuticals
Qualification: DRSc
Dr. Jamieson has built an international reputation around his ability to develop innovative regulatory solutions which enable
companies and university researchers to get their products and facilities through the regulatory hurdles in a timely fashion.
He is an experienced Senior Manager with over twenty years of diverse international research and development,
regulatory approval and regulatory compliance expertise. In recent years he has spent a significant portion of his time in
South America overseeing the building of GMP compliant manufacturing facilities. In 1991, Dr. Jamieson founded
Pharmacon Research Inc. (Ottawa, Ontario, Canada and London, U.K), to assist international companies in the
development of integrated new product development programs for the North American market.
Dr. Jamieson has a Doctorate in Regulatory Science from the University of Southern California.
Eddie Crabbe
Courses
427A - Fermentation Principles Module I
Adjunct Professor, KGI
Qualification: PhD
Dr. Crabbe has over 12 years experience in aerobic and anaerobic fermentation process development for recombinant
protein and bioenergy production, technology transfer, and manufacturing support. Currently, Eddie works at Allergan
in Irvine, California as a Senior Scientist in Biologics Development Process Sciences. In this role, he leads the design,
development, scale up, characterization, and transfer of fermentation and primary recovery processes for the
production of biologics and enzymes. He provides technology transfer expertise to in-house and external development
and commercial manufacturing partners as well as contributing to manufacturing sections for CMC regulatory filings.
Prior to joining Allergan, he worked as a Senior Scientist in Kam Biotechnology in Surrey, Canada where he developed
a lab scale platform for microbial hydrogen production from biological waste streams, provided proof-of-concept for a
two-step continuous bioethanol production process, and supported manufacturing of bio-based (fungal and bacterial)
products for applications in wastewater treatment.
Dr. Crabbe received a PhD in Microbial Technology, Food Science and Technology from Kyushu University in Japan.
For more information, visit www.bioconacademy.com
Adding Value, Enhancing Skills
Faculty at
Biocon Academy
The Experts who develop the
Bioscientists of tomorrow
Christopher Shen
Courses
429 - Bioseparation Engineering and Science
Adjunct Professor, KGI
Qualification: PhD
Dr. Shen is currently a Scientist at Allergan where he works in microbial process development for biopharmaceutical
production. Prior to Allergan, he was a postdoc at KGI under Matt Croughan, where he worked on CHO culture media
supplementation and stem cell process development. He regularly teaches bioseparations at KGI as an Adjunct
Professor.
Shen received his BS with high honors in Bioengineering from UC Berkeley and his PhD in Biomedical Engineering from
the joint program at Georgia Institute of Technology and Emory University in 2011. He completed his PhD work on
multifunctional nanoparticles for diagnostics and drug delivery under Shuming Nie.
KiriLynn Svay
Courses
427B - Mammalian Cell Biotechnology Module II
KGI Lecturer, Director of KGI Bioprocess Engineering Operations
Qualification: Pursuing MBS PhD at KGI
KiriLynn has been an instructor in the KGI Amgen Bioprocessing Center since 2007, leading the Mammalian Cell
Technology lab course (ALS 427) in the Fall Semester and Bioseparations Lab (ALS 422).
In addition to her teaching, KiriLynn also manages the various industry sponsored projects, independent research, and
oversees the daily operations in the Amgen Bioprocessing Center. Examples of sponsored projects include evaluating
Alpha and Beta pilot scale disposable bioreactors that utilize Air Wheel mixing systems to mix and promote low shear and
rapid homogenous mixing in cell culture; and validating and evaluating an animal free cell culture supplements for the use
in Biomanufacturing, cell culture, and biopharmaceutical formulations.
For more information, visit www.bioconacademy.com
Adding Value, Enhancing Skills
Biocon-KGI Certificate
Program in Biosciences
Course Details
Course Code ALS 300
Molecular Biotechnology
In this module, students will be exposed to the conceptual foundations of biotechnology and the role played by discoveries and applications of molecular
biology principles in advancing biotechnology horizons. This is a case-based course in which students learn about landmark original papers and patents that
shaped biotechnology.
Upon completion of this course, students will gain an understanding of the concepts and techniques that are currently being used in the biotechnology and
pharmaceutical industry.
Course Code ALS 333
Pharmaceutical Development
The course is designed to provide an understanding of how Pharmaceutical companies discover, develop, and bring drugs and biopharmaceuticals to market.
This course will focus on development of traditional and biological drugs. It will cover the process of drug development, taking the drug substance through the
process of becoming a drug product, and then into clinical development and commercialization.
Case studies from industry will be presented detailing companies and products that utilize state-of-the-art discovery techniques and advanced drug delivery
systems. This is a science course that freely intersperses business and regulatory issues into the lectures and assignments.
Course Code ALS 418
Biopharmaceutical Quality Assurance and Control
Production of biotechnology products requires comprehensive quality standards and systems that meet global cGMP expectations and are based upon thorough
scientific knowledge of the product and process. Professionals knowledgeable in the principles and practice of biopharmaceutical quality management are in
high demand and hold positions of significant responsibility within the private and public sectors of the healthcare industry.
The primary goal of this course is to provide students with an advanced background in the principles and requirements of biopharmaceutical quality assurance
and control. Through a series of lectures and case studies, this course will develop the critical thinking and judgment skills that are needed for the development
of quality systems and the resolution of product quality issues.
For more information, visit www.bioconacademy.com
Adding Value, Enhancing Skills
Biocon-KGI Certificate
Program in Biosciences
Course Details
Course Code ALS 419
CMC Regulations of Pharmaceuticals
Regulatory Chemistry, Manufacturing and Control (CMC) requirements determine the strategy parameters for new pharmaceutical process development and
changes post approval. Knowledge of CMC requirements and relevant agencies is a key success factor in pharmaceutical approval and compliance. In particular,
globalization has caused a significantly more complex regulatory environment for the manufacture and distribution of pharmaceuticals (and medical devices).
Most product supply chains are now multinationals with an increasing trend towards investment in rapidly developing but poorly regulated nations.
The development of regulatory strategies for product development and post approval changes require the understanding of many national regulatory agencies
and international harmonization efforts. Often the introduction of product production and distribution improvements is limited by the effectiveness of the
Chemistry, Manufacturing and Control (CMC) regulatory strategy employed by the firm.
Effective CMC organizations coordinate with global regulatory agencies to develop risk-based approaches to inspection frequency and focus. Similar risk-based
approaches are developed with global regulatory agencies to detect and prevent counterfeiting and product diversion.
Professionals knowledgeable in the principles and practice of regulatory CMC requirements are in high demand and hold positions of significant responsibility
within the private and public sectors of the healthcare industry. The primary goal of this course is to provide students with an advanced background in the
principles and requirements of regulatory CMC including Post-Approval reporting requirements, Deviation reporting, Inspection coordination and resolution,
and Good Distribution Practices (GDP) practices. Through a series of lectures and case studies, this course will teach the critical thinking and judgment skills that
are required for the development of CMC regulatory strategies and influence.
Course Code ALS 462
Introduction to US FDA and European Laws and Regulations
This course will provide students with broad general competencies in regulatory affairs for all US FDA regulated product classes (drugs, biologics and devices)
throughout the product lifecycle (pre-clinical development, clinical development and post marketing). Emphasis will be placed on regulatory interactions,
submissions, other communications and inspections, for each product class and for each phase of the product lifecycle. European regulations will also be
reviewed.
For more information, visit www.bioconacademy.com
Adding Value, Enhancing Skills
Biocon-KGI Certificate
Program in Biosciences
Course Details
Course Code ALS 427A
Fermentation Principles - Module I
Fermentation as a part of the bioprocess industry makes use of the microbial, animal and plant cells, and components of cells such as enzymes to manufacture
enormous range of commercial products from relatively cheaper material such as industrial alcohol and organic solvents to expensive specialty chemicals such as
antibiotics, therapeutic proteins and vaccines. The advancement and development of the fermentation process have led to the manufacturing of recombinant
DNA derived products such as insulin, human growth hormone and interferon.
The knowledge and skills required to turn these products into commercial reality requires working with various interdisciplinary scientists and engineers to
develop the necessary platforms from genetic manipulation and cell line development to scaling up the process to a pilot scale bioreactor and eventually
industrial scale operations.
This course will focus on both the fermentation processes and the principles of bioprocessing engineering through a series of lectures, presentations and case
studies.
Course Code ALS 427B
Mammalian Cell Biotechnology - Module II
Mammalian cell biotechnology has undergone explosive growth over the last 30 years. Bioscientists skilled in mammalian cell biotechnology are in high
demand. The primary goal of this course is to provide students with an advanced background in mammalian cell biotechnology. The scientific, engineering, and
practical industrial aspects will be presented through a series of lectures and student presentations.
This course will focus on both the fermentation processes and the principles of bioprocessing engineering through a series of lectures, presentations and case
studies. Students should have a background in chemistry, biological science or a related discipline.
For more information, visit www.bioconacademy.com
Adding Value, Enhancing Skills
Biocon-KGI Certificate
Program in Biosciences
Course Details
Course Code ALS 429
Bioseparation Engineering and Science
Bioprocess engineering, including bioseparations, was and often still is a major skill set of professionals like brewers, winemakers, or in ancient times, wizards or
sorcerers. Success in large-scale recombinant protein manufacturing is a recent manifestation of a long and glorious history of the field.
The primary goal of this course is to provide students with an advanced background in bioseparations science and engineering. Graduates in molecular biology,
bioengineering, and many other fields can potentially take advantage of opportunities in pharmaceutical biotechnology, biotechnology development,
manufacturing, commercial operations, quality assurance, regulatory affairs, business development, licensing, and investment fund management. To access such
opportunities quickly and successfully, it is valuable to understand the basic principles of bioprocess engineering and to have an advanced background in a
subspecialty or application area, such as fermentation, cell culture, and/or bioseparations. This type of knowledge and experience can be applied to a career in
pharmaceutical biotechnology, and to other areas of biotechnology, such as biofuels.
Professional Skills Development
To complement the technical functional skills, the Professional Skills Development course has been integrated in the program curriculum to help students
develop their professional skills. This course module includes:
Campus to Corporate - Introduction
Networking
Report Writing
Presentation Skills
Office Etiquette
Communication Skills
Email Etiquette
Giving a successful interview
Industry – Academy Interaction
The course will encompass face-to-face interaction with the subject matter experts from Biocon, others in the industry and academia.
For more information, visit www.bioconacademy.com