General Details

Full Title
Transcript Title
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
LIFE - Life Sciences
08 - NFQ Level 8
05 - 05 Credits
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Stephen Daly, Ailish Breen
Programme Membership
SG_SMEDI_H08 201900 Bachelor of Science (Honours) in Science in Medical Biotechnology SG_SMEDI_K08 201900 Level 8 Honours Degree Add-on in Science in Medical Biotechnology

This course will provide the student with a broad knowledge, understanding and appreciation of the principal features and aspects of a modern biomedical manufacturing or services related environment.

Learning Outcomes

On completion of this module the learner will/should be able to;


Outline how a modern biopharmaceutical/biomedical/med tech manufacturing industry operates, and demonstrate understanding of the regulatory requirements of these industries.


Adapt and apply knowledge and skills acquired in the educational environment to the industrial, services or other scientific related work environment.


Analyse and critique scientific information/data relating to the industrial working environments in both a team-based and professional report format.


Propose and defend solutions to real/simulated complex workplace problems.


Differentiate personal roles and responsibilites from that of the team's during professional problem solving activities.

Teaching and Learning Strategies

This module will be delivered as a combination of lectures, online content delivery, problem based workshops, site tours and industry guest speakers. 

Module Assessment Strategies

The Placement and Case Studies module will be examined through 100% continuous assessment. A range of assessment types will be employed to explore student's learning and knowledge, including quizzes, workshops, case studies, data analysis and presentations. Team skills and project management skills will be developed through the use of specific workshops, where students will be assigned into small working groups and given specific industry related case studies. Students will work together within a defined time to formulate decisions in relation to a complex or highly regulated environment.

A key focus of this module is to develop the student's presentation skills. This will be carried out through formative and summative assessments. Formative assessment will include class room discussions on industry related topics enabling the students to become comfortable with discussing science and regulatory issues in an informal manner. A summative oral presentation/poster assessment will be included in a conference type environment on each work placement or equivalent project. 

Repeat Assessments

Students will have opportunities to re-submit work as agreed with their lecturer.

Module Dependencies


Indicative Syllabus

1. Students will research and write an independent report related to a work placement experience or assigned case study demonstrating understanding of the industry, regulatory affairs, and acknowledging personal knowledge and skills gained.  2. Students will be required to give a professional presentation on some aspect of the biopharmaceutical/biomedical industry workplace.    3. Lectures and workshops will be organised to cover industry related topics such as lean sigma, technology transfer, project management, auditing, professional development, problem solving and data analysis etc. 4. Students will be expected to perform analysis of these activities as a team and also via personal reflective exercises, self and peer assessment so that their contribution to 'team' is well defined.

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
100 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Work Placement or Industry experience (if applicable) Formative UNKNOWN - % OnGoing 1,2
2 Written report & presentation. Professional practice in a scientific related work environment or simulated workplace problem. Continuous Assessment UNKNOWN 50 % Week 10 1,2
3 Workshop reports/activity Continuous Assessment Performance Evaluation 20 % Week 8 3
4 Case studies activites and reports Continuous Assessment Assignment 30 % OnGoing 4,5

Full Time Mode Workload

Type Location Description Hours Frequency Avg Workload
Lecture Lecture Theatre Lecture 2 Weekly 2.00
Problem Based Learning Flat Classroom Workshops 2 Weekly 2.00
Workshop Not Specified Work placement conference 0 Once Per Semester 0.00
Independent Learning Not Specified Self Study 4 Weekly 4.00
Total Full Time Average Weekly Learner Contact Time 4.00 Hours

Required & Recommended Book List

Required Reading
2005-06-05 What is Lean Six Sigma McGraw Hill Professional
ISBN 0071490353 ISBN-13 9780071490351

A quick introduction on how to use Lean Six Sigma to improve your workplace, meet your goals, and better serve your customers. Lean Six Sigma combines the two most important improvement trends of our time: making work better (using Six Sigma) and making work faster (using Lean principles). In this plain-English guide, youll discover how this remarkable quality improvement method can give you the tools to identify and eliminate waste and quality problems in your own work area. Packed with diagrams, cartoons, and real-life examples, What is Lean Six Sigma? reveals the four keys of Lean Six Sigma and how they apply to your own job: Delight your customers with speed and quality Improve your processes Work together for maximum gain Base decisions on data and facts Youll see the big picture of what your company hopes to gain with Lean Six Sigma, how it may affect your work area, and what it can mean to you personally.

Required Reading
2018-01-18 Biopharmaceutical Processing Elsevier
ISBN 9780128125526 ISBN-13 0128125527

Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing Processes covers bioprocessing from cell line development to bulk drug substances. The methods and strategies described are essential learning for every scientist, engineer or manager in the biopharmaceutical and vaccines industry. The integrity of the bioprocess ultimately determines the quality of the product in the biotherapeutics arena, and this book covers every stage including all technologies related to downstream purification and upstream processing fields. Economic considerations are included throughout, with recommendations for lowering costs and improving efficiencies. Designed for quick reference and easy accessibility of facts, calculations and guidelines, this book is an essential tool for industrial scientists and managers in the biopharmaceutical industry. Offers a comprehensive, go-to reference for daily work decisions Covers both upstream and downstream processes Includes case studies that emphasize financial outcomes Presents summaries, decision grids, graphs and overviews for quick reference

Required Reading
2002-09-25 Six Sigma and Beyond CRC Press
ISBN 1420000276 ISBN-13 9781420000276

In this volume of the Six Sigma and Beyond series, quality engineering expert D.H. Stamatis focuses on how Statistical Process Control (SPC) relates to Six Sigma. He emphasizes the "why we do" and "how to do" SPC in many different environments. The book provides readers with an overview of SPC in easy-to-follow, easy-to-understand terms. The author reviews and explains traditional SPC tools and how they relate to Six Sigma and goes on to cover the use of advanced techniques. In addition, he addresses issues that concern service SPC and short run processes, explores the issue of capability for both the short run and the long run, and discusses topics in measurement.

Required Reading
2016-04-08 Business Development for the Biotechnology and Pharmaceutical Industry CRC Press
ISBN 9781317170594 ISBN-13 1317170598

Business Development in the biotechnology and pharmaceutical industries accounts for over $5 billion in licensing deal value per year and much more than that in the value of mergers and acquisitions. Transactions range from licences to patented academic research, to product developments as licences, joint ventures and acquisition of intellectual property rights, and on to collaborations in development and marketing, locally or across the globe. Asset sales, mergers and corporate takeovers are also a part of the business development remit. The scope of the job can be immense, spanning the life-cycle of products from the earliest levels of research to the disposal of residual marketing rights, involving legal regulatory manufacturing, clinical development, sales and marketing and financial aspects. The knowledge and skills required of practitioners must be similarly broad, yet the availability of information for developing a career in business development is sparse. Martin Austin's highly practical guide spans the complete process and is based on his 30 years of experience in the industry and the well-established training programme that he has developed and delivers to pharmaceutical executives from across the world.

Module Resources

Non ISBN Literary Resources

Course Guideline Notes relating to Industrial Placement Assignment.


Journal Resources


URL Resources


Other Resources


Additional Information

A requirement for this module is that the student to lecturer ratio for workshops and conference is 25/1.