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Why should you join the program?The 16 week industry oriented Biocon-KGI Certificate Program in Biosciences, delivered by

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.

For details on the eligibility, course curriculum and scholarship, please turn overleaf.

Biocon-KGI CertificateProgram in BiosciencesDesigned 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.

This program enables:

Face-to-face interaction with renowned

subject matter experts from Biocon,

industry and academia

Mentorship by the industry and

experienced faculty from KGI and

Biocon Academy

3 hours of KGI Lessons + 1 hour

classroom assignments on daily basis

Thrice a week functional visit to

Biocon facilities with assignments from

KGI on Quality, R&D and Regulatory

Post classroom session and GMP

training

Professional skills development and

personal grooming through weekly

training sessions

Learning from internationally recognized experts

Development of job-skills through practical exposure

If you are interested in leading the future

of Biosciences, submit your application for

the program before December 6, 2013.

Visit www.bioconacademy.com

Education Partner

Admissions for the 2014 batch ofBiocon-KGI Certificate Programin Biosciences is now open!

Admissions

For more information, visit www.bioconacademy.com

Adding Value, Enhancing Skills

CGPA: 7.5 (71 percentage) and above

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:

Break in career: 1 year and less from HSC/PUC to the current highest degree

Who can join the program?

BE/B.Tech in Biotechnology/Industrial Biotechnology

MSc. in Biotechnology /Microbiology/ Biochemistry/ Biology

B.Pharm

Educational Qualification:

For more details on

Biocon-KGI Certificate

Program in Biosciences

Visit:

Call:

E-mail:

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latest updates

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Molecular Biotechnology

Biopharmaceutical Quality Assurance and Control

Introduction to US FDA and European Laws and Regulations

Bioseparation Engineering and Science

Pharmaceutical Development

CMC Regulations of Pharmaceuticals

Fermentation Principles - Module I

Mammalian Cell Biotechnology - Module II

Professional Skills Development

Course Name Course Code

ALS 300

ALS 418

ALS 462

ALS 429

ALS 333

ALS 419

ALS 427A

ALS 427B

75%of the program fee to all selected students.

Biocon Scholarship

Program Fee - INR 6,00,000

Student’s Share - INR 1,50,000

at Biocon Ltd and other leadingBiotech companies

Job Opportunity

[email protected]

+91 80 6775 1868

www.bioconacademy.com

SS.EaswaranAcademic 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 JoshiProgram Director and Faculty for the Biocon-KGI Certificate Program in Biosciences

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.


Courses 333 - Pharmaceutical Development

Faculty for Functional Projects

Faculty at Biocon AcademyThe Experts who develop the Bioscientists of tomorrow


Qualification: PhD, Biological Sciences | PPM

Susan BainProfessor KGI

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.

Anastasia LevitinAssistant Professor, KGI

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.

Qualification: PhD

Courses 418 - Biopharmaceutical Quality Assurance and Control

462 - Introduction to US FDA and European Laws and Regulations

419 - CMC Regulations of Pharmaceuticals




Courses 300 - Molecular Biotechnology

Dr. Bain has a Doctorate in Regulatory Science from the University of Southern California.

Michael JamiesonAdjunct Professor, KGI

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.

Eddie CrabbeAdjunct Professor, KGI

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.

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.


Qualification: DRSc

Qualification: PhD

Courses 462 - Introduction to US FDA and European Laws and Regulations

419 - CMC Regulations of Pharmaceuticals

Courses 427A - Fermentation Principles Module I



Dr. Jamieson has a Doctorate in Regulatory Science from the University of Southern California.

Dr. Crabbe received a PhD in Microbial Technology, Food Science and Technology from Kyushu University in Japan.

Christopher ShenAdjunct Professor, KGI

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.

KiriLynn SvayKGI Lecturer, Director of KGI Bioprocess Engineering Operations

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.

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.


Qualification: PhD



Courses 429 - Bioseparation Engineering and Science

Courses 427B - Mammalian Cell Biotechnology Module II

Qualification: Pursuing MBS PhD at KGI

Course Code ALS 300

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.

Molecular Biotechnology

Course Code ALS 333

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.

Pharmaceutical Development

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.


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 418

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.

Biopharmaceutical Quality Assurance and Control

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.

Biocon-KGI CertificateProgram in Biosciences Course Details


Course Code ALS 419

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.

CMC Regulations of Pharmaceuticals




Course Code ALS 462

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.

Introduction to US FDA and European Laws and Regulations

Course Code ALS 427A

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.

Fermentation Principles - Module I

Course Code ALS 427B

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.

Mammalian Cell Biotechnology - Module II




Course Code ALS 429

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.

Bioseparation Engineering and Science

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:

Professional Skills Development

The course will encompass face-to-face interaction with the subject matter experts from Biocon, others in the industry and academia.

Campus to Corporate - Introduction

Report Writing

Office Etiquette

Email Etiquette

Networking

Presentation Skills

Communication Skills

Giving a successful interview




Industry – Academy Interaction

adding value, enhancing skills biocon-kgi certiﬁcate ... · dr. shen is currently a scientist at...

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