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Entrepreneurship and Biopharmaceutical Manufacturing
Master of Science
Course Details
Course Code | GA_SEBMG_V09 |
---|---|
Level | 9 |
Duration | 1 year |
Credits | 90 |
Method of Delivery | Blended |
Campus Locations | Galway City – Dublin Road |
Mode of Delivery | Full Time |
Course Overview
The Master of Science in Entrepreneurship and Biopharmaceutical manufacturing is a 90-credit, 2-year full-time programme delivered across four academic semesters. The course has been designed with significant input from industry experts to meet the demands of the biopharmaceutical sector.
The course offers a wide range of modules covering topics related marketing, finance, leadership, management, as well as biopharmaceutical science, bioprocess technology, validation, Six Sigma, quality and regulatory affairs. The research aspect of the programme offers a 2-phase research project centred around the theoretical design, development, commercialisation and marketing of a novel biopharmaceutical product. To aid this research, supporting modules such as design of experiments and research methods will be offered.
The program aims to equip learners with interdisciplinary, cutting-edge skills and knowledge essential for the biopharmaceutical sector.
Course Details
Year 1
Semester | Module Details | Credits | Mandatory / Elective |
---|---|---|---|
1 |
Strategic Marketing and CommunicationsThe curriculum aims at providing the students with the latest thinking and practice in strategic marketing and communications, with a particular twist on marketing of innovation, growth and sustainable performance. Learning Outcomes 1. Critically appraise the role of strategic marketing andcommunications in growing sustainable organisational success in a variety of global markets and business environments. 2. Analyze the business market environment, market trends, and the concept of consumer behaviourto inform strategic decision-making. 3. Identify and critically evaluate marketing data and marketing information sources and interpret their impacts on strategic marketing and communication issues. 4. Analyze the theory ofmarket segmentation,target marketing, positioning strategies and the concept of value propositions. 5. Select from the toolkit of marketing concepts and analytical frameworks to formulate strategic marketing plans and integrated communication plans. |
05 | Mandatory |
1 |
Principles of Finance and AccountingThis module is designed to introduce learners to the area of accounting and financial management. It looks in detail at what financial management is, its relationship to financial accounting and management accounting, the budgeting process, capital investment appraisal, the importance and management of working capital, and finance and investment decision-making based on accounting statements. The module is designed to take a high level view of the individual topics to facilitate those working in non-financial management positions in industry. Learning Outcomes 1. Have knowledge pertinent to financial management and an in-depth understanding of its importance in the business and corporate environment. 5. Analyse and interpret financial statements for the purposes of investment decisions. |
05 | Mandatory |
1 |
Six Sigma ManagementThe module introduces the concepts of operational excellence and examines their applications to the Life Sciences. This module aims to give the student the necessary skills to plan and implement a range of Six Sigma programme activities in a workplace environment. The module will focus on the tools & techniques required to reduce process variability and thereby achieve Lean Six Sigma in manufacturing and ensure continuous process improvement. Learning Outcomes 1. Capitalise on the synergy between Lean and Six Sigma and construct an enterprise wide view of their application in the Life Science sector. 2. Develop and lead the implementation of a Lean Six Sigma program activity. 3. Recommend/Implementstatistical tools fromthe Six Sigma Define Measure Analyse Improve Control (DMAIC) toolkit for process improvement. 4. Evaluate and apply appropriatestrategic and tactical design tools (DFSS). |
05 | Mandatory |
1 |
Validation for BiopharmaceuticalsThis module aims to provide learners with a broad understanding of Validation in the Biopharmacuetical manufacturing context, including Process, Equipment, Cleaning, Automated System and Test Method Validation. Learning Outcomes 1. Investigate the regulatory basis for Validation and the relatedrequirements of the (Bio)pharmaceutical sector from regulatory bodies. 2. Communicate the key steps required for anyValidation and fully comprehendthe underpinning principles of specification and verification. 3. Participate and add value as ateam member in industry on multiple types of Validation projects, e.g.Process, Equipment, Cleaning, Automated System orTest Method Validation. 4. Implement the principles of Validation to design and develop Validation documents. 5. Apply risk management and change control to Validation activities and Validated entities, e.g. Process, Equipment, Test Methods. 6. Determine and assess the key validation characteristics of a test method and factors that influence test method variability. |
05 | Mandatory |
2 |
Bioprocessing TechnologyThis module pertains to the manufacture of modern biologic products and focuses on various aspects of a typical biopharmaceutical production process such as cell culturing, upstream and downstream processing, biopharmaceutical analysis, formulation, lyophilisation, fill, finish and packaging, The module will also focus on emerging trends in biopharmaceutical manufacturing such as continuous bioprocessing and the move towards the use of single use technology in biopharmaceutical manufacturing. Learning Outcomes 1. Illustrate and implement an understanding of the key steps involved the delivery and formulation of Biopharmaceuticals 2. Evulateand critical appraise thetechnologies, processesand the technical parameters pertinent to cell culture, upstream and downstream processingwith emphasis on the emergence of technologiessuch as continuous manufacturing and single use technologies for biopharmaceutical manufacturing. 3. Analyse and apply knowledge of the key parameters in biopharmaceuticallyophilization, fill, packaging and labelling. 4. Corroborate an indepth knowledge of the key parameters in biopharmaceutical analysis. |
05 | Mandatory |
2 |
Quality Management Systems and Regulatory AffairsThis module reviews the key regulatory requirements for (bio)pharmaceutical product development, production and marketing. It addresses the role of quality management in determining key factors such as efficacy, purity and safety. It describes the ISO 9000 quality standard requirements of biopharmaceutical manufacturing and addresses the role of ISO 9000 certification in achieving these standards. It describes the difference between quality standards and international regulatory requirements and how quality management is associated with regulatory compliance. It addresses the regulatory requirements of various international regulatory authorities such as the FDA and EMA, National Authorities (i.e..HPRA) and describes the role of the more general ICH guidelines in meeting regulatory requirements. Learning Outcomes 1. Demonstrate a clear understanding of the role of quality assurance throughout the lifecycle of a biopharmaceutical productand identify key elements monitored by the quality control system in the manufacture of a biopharmaceutical drug. 2. Evaluate the regulatory demands of agencies such as the European Medicines Evaluation Agency (EMA) and Food & Drug Administration (FDA) in terms of the development, production, characterisation and evaluation of biopharmaceutical products 3. EvaluateCritical Quality Attributes (CQA) for biopharmaceutical manufacturing and critically analyse CQAs that demonstrate compliance with regulatiions for different types of biopharmaceuticals. 4. Analyse the role of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use(ICH) in regulating biopharmaceuticaldrugs and apply QbD principles to the step-by-step development of a purification process for a biopharmaceutical drug |
05 | Mandatory |
2 |
Research ProjectThe project should take the form of a proposal for the development of a medical technology (biopharmaceutical or medical device product) to prevent, treat or diagnose a specific medical condition. The student will undertake a literature review to source information on the target condition and current therapies for the treatment of the disease. Based on this information and the student's knowledge gained through the programme, the student should propose an alternative product/technology, for prevention, treatment or diagnosis of said medical condition. Thereafter, students should include a detailed overview of the design, function, clinical trials, manufacturing, marketing and financial strategy of their proposed product. Learning Outcomes 1. Lead the development of a proposal for the development of a novel medical technology product. 2. Critically evaluate and reviewliterature (and other relevant, reliable sources) using appropriate keywords and databases. 3. Synthesize and collate relevant information from the programme modules to apply their knowledge to a current medical concern and the proposed design, manufacture, marketing and financial strategy of medical technology. 4. Communicate results of the reviewin written and oral forms, demonstrating critical analysis, synthesis and organisation of knowledge. |
10 | Mandatory |
2 |
Managing InnovationInnovation is a key element in successfully growing business and competing in an ever-changing global environment. This module provides learners with an understanding of innovation at individual and firm level. An appreciation of the ever-changing macro and micro environments and stakeholder interest for contemporary organisations will be integral to the module. Learners will appraise different approaches to innovation. A key focus will be the drive for business growth in today's rapidly changing business landscape. The development of effective organisation-wide strategies in the successful management of innovation in any industry. Learning Outcomes 1. Demonstrate the economics of innovation and implications of the macro environment and stakeholder interests in successfully driving business growth. 2. Appraise effective approaches to innovation. 3. Establish and implement organisation wide strategies in the management of innovation. 4. Explore approaches for enhancing organisational creativity. 5. Assess the importance of people, culture and organisation in the effective management of innovation. |
05 | Mandatory |
2 |
Leadership and TeamsEffective leadership is needed to understand, predict, plan and communicate the nature of organisational change and manage the response. This module explores various opportunities and challenges associated with leading and managing organisational change. Through the learning outcomes mentioned below, learners will be equipped with the knowledge, skills and attitudes necessary to effectively lead and collaborate with teams in a variety of organisational settings. It fosters collaborative engagement through the understanding of cross-functional teams within an organisation. Learning Outcomes 1. Demonstrate an understanding of leadership theories and concepts. 2. Develop essential and ethical leadership skills/practices, while enhancing personal leadership development 3. Apply leadership strategies to diverse/challenging situations 4. Foster effective team dynamics, by identifying and leveraging the strengths of team members to achieve collective goals. 5. Apply effective strategies for team building and employee engagement. |
05 | Mandatory |
Year 2
Semester | Module Details | Credits | Mandatory / Elective |
---|---|---|---|
1 |
Design and Analysis of ExperimentsThis module provides the student with the design of experiments concepts, tools and techniques for optimising products and processes. The student will learn to build empirical models of a process and assess their validity. The R statistical software or equivalent will be used extensively for data analysis and interpretation. Learning Outcomes 1. Demonstrate principles of statistical design, hypothesis testing and model diagnostics 2. Plan, conduct and analyse experiments using completely randomised design (CRD) and randomised block design 3. Design,analyse and interpret the results of the factorial, fractional factorial and repeated measures design 4. Analyse and interpret data from experiments involving latin square design, split plots and response surface design 5. Review concepts of statistical power and sample size and theirimplications for design and analysis of experiments |
05 | Mandatory |
1 |
Research MethodsResearch methodology is an integral part of any Masters course. The aim of this module is to ensure that students will be fully competent to devise, run and present research in a professional manner. Learning Outcomes 1. Systematically review and evaluate current literature, using appropriate tools and techniques. 2. Identify, analyse and evaluate appropriate research methods for research project proposal development. 3. Demonstrate the synthesis and integration of knowledge. 4. Draft a research proposal appropriate to their career stage and aligned with their research interests. 5. Create an appropriate data management structure. 6. Communicate research in various formats including written and oral presentation methods. |
05 | Mandatory |
Year |
Advanced Biopharmaceutical ScienceThis module explores contemporary issues in biopharmaceutical science and examines novel emerging new technologies in this industry. It will evaluate and explore the current trends in Advanced Therapy Medicinal Products (ATMPs) such as cell therapies. It will also focus on emerging trends in biopharmaceutical science such as complex antibodies, genetic vaccines, personalised medicines and 'omics'. Learning Outcomes 1. Critically evaluate the current trends in Advanced Therapy Medicinal products (ATMPs) with a focuson engineered T lymphocytes. 2. Evaluateand critical appraiseall aspects ofmonoclonal antibodyengineering and analyse the effect that various biochemical and genetic engineering approaches will have onfuture therapeutic antibodies. 3. Compare andcontrasts the various approaches used in the design, delivery and manufacture of genetic vaccines to the body forthe treatment of infections andnon-infectious diseases. 4. Critically assess the use of ‘omics’ technologies in (bio)pharmaceutical research and development |
10 | Mandatory |
Year |
Comercialisation ProjectStudents will undertake an approved research project under the direction of an internal supervisor and, if appropriate, a supervisor from a relevant external organisation. Design of the project should be produced by the learner with the advice of the supervisors and may also be of relevance to an organisation such as an employer. Learners enroled are expected to develop the knowledge, know-how and skills, and competencies required to successfully research, develop, scope the project and present and project implementation plan. Learners are expected to either individually or as part of a team develop research, problem analysis, project planning and communication skills at masters level. Projects may be drawn from any discipline within the course or from an area of expertise of the supervisors. Learning Outcomes 1. Identify and choose a research project topic and plan the delivery of that research project. 2. Demonstrate critical engagement with existing literature or commercial practice relevant to their topic. 3. Develop creative ways of solving new research problems. 4. Collect and analyse data qualitatively and quantitatively, including an assessment of the statistical validity of the research results. 5. Communicate research results in written and oral forms, demonstrating critical analysis, synthesis and organisation of knowledge, and |
20 | Mandatory |
Recommended Study Hours per week
Examination and Assessment
individual/group projects, assignments, closed-book written exams, oral presentations and thesis submission.
On-Campus Attendance Requirement
Progression
Graduates of the MSc in Entrepreneurship and Biopharmaceutical Manufacturing can progress to Level 10 programme, which may be undertaken at various research centres or groups based across ATU campuses.
Download a prospectus
Entry Requirements
A H2.2 Bachelor degree at level 8 in a cognate science discipline such as biochemistry, microbiology, biology, biomedical science/engineering or equivalent, is the minimum entry requirement for this programme.
English Language Requirements:
English Language Requirements for this programme is 6.0 (ILETS score). English language requirements are determined by ATU and are published in the Access, Transfer and Progression code[OS1] .
Alternative Admission Routes:
ATU is committed to the principles of transparency, equity and fairness in recognition of prior learning (RPL) and to the principle of valuing all learning regardless of the mode or place of its acquisition. For applicants without this qualification, the RPL process of ATU will be used to determine admission to the programme. Academic Code of Practice No. 6 outlines the policies and procedures for the Recognition of Prior Learning and guidance for applicants is provided on myexperience.ie[OS2].
Learners who have completed either the Postgraduate Certificate in Entrepreneurship and Biopharmaceutical Manufacturing or the Postgraduate Diploma in Entrepreneurship and Biopharmaceutical Manufacturing [OS3] are eligible for entry.
Careers
There are many opportunities for graduates of this programme within the biopharmaceutical sector, including roles such as Biotechnical Production Specialist, Process Scientist, Process Engineer, Technical Operations Specialist, Team Leader, Validation Specialist, Operations Lead or Manager, Associate Director, and Core Technology Operations Lead.
Further Information
Who Should Apply?
The programme is aimed at graduates who have either a science or engineering background and are aiming to progress their careers in a leadership/managerial role.
Contact Information
Analytical, Biopharmaceutical & Medical Sciences