Regulated New Product Introduction & Technology Transfer

Overview

The MSc in Regulated New Product Introduction and Technology Transfer has been developed between the Engineering faculty at MTU and a number of Life-science industry partners, as part of the iEd Hub suite of industry-facing programmes.

The aim of the MSc in Regulated New Product Introduction and Technology Transfer is to enable learners to develop their technical and transversal skills to support the transfer of new pharmaceutical and biopharmaceutical products in and out of manufacturing facilities while operating in a GxP regulated environment.

Ultimately, graduates will develop fluency in several technical areas including quality, validation and risk management, paperless validation, life science project management in a regulated environment, data analytics and visualization, operations and production suite transfer readiness, Lean Six Sigma skills, research skills, analytical laboratory technology transfer, engineering facilities and utilities. All of these modules will be tuned specifically for the field of new product introduction and technology transfer during their modes of delivery focusing on pharmaceutical, biopharmaceutical, API, and advanced therapies manufacturing.

Course Delivery

Part-time over 2 academic years (4 semesters)

Each semester is of 15 week duration (including examinations). Presentation of the course consists of lectures, tutorials, cloud-based laboratory practicals and visiting industry guest lectures where applicable.

• Stage 1/Semester 1 – Monday & Wednesday
• Stage 1/Semester 2 – Monday & Wednesday
• Stage 2/Semester 1 – Monday & Wednesday
• Stage 2/Semester 2 – Monday & Wednesday
• Stage 2/Semester 1 & 2 – Research project

This programme will be blended delivery in the coming academic year. While much of the lectures will take place online, students may be required to attend campus on a couple of occasions each semester and will have to attend on-campus for their final examinations at the end of each semester, where modules are not 100% continuous assessment.

Development of this course has been supported by the Higher Education Authority under the Human Capital Initiative, Pillar 3. Grant agreement: 18351800 ‘The iEd Hub’ https://iedhub.ie

What will I study?

CHEP9005 Quality, Validation & Risk Management:

This module addresses quality, validation, and risk management aspects of New Product Introduction (NPI) technology transfer in biopharmaceutical & pharmaceutical manufacturing environments. Using paperless validation software as a platform, the learner will experience paperless validation concepts based on real-world industry applications relevant specifically to NPI.

CHEP9004 Life-science Project Management:

This module will provide the student with a detailed knowledge of project management (PM) specifically in the life science sector where quality and safety are paramount. GxP and sustainability concepts will be integrated with relevant project management activities, to ensure quality & safety risks are managed effectively and proactively during the term of a life science project.

DATA9007 Data Analytics & Visualization:

In this module, the learner will learn to aggregate, process, and present data while also exploring advanced visualisation techniques relevant to extracting business intelligence, for a manufacturing environment. Best practices in process and product quality monitoring for clinical and commercial manufacturing will also be demonstrated.

MECH9005 Research Skills & Questions:

The aim of this module is to develop competent researchers and to support and develop their research skills– critiquing published research, utilising available research resources. At the end of the module the student should have selected a research question and be able to defend the validity and importance of the developed question.

INTR9028 Lean Six Sigma Skills:

This module will present lean six sigma skills & continuous improvement methodology that is applicable to modern manufacturing operations.

CHEP9006 Operations Transfer Ready:

This module provides a concise insight into pharmaceutical & biopharmaceutical manufacturing operations while considering regulatory, bioprocess operations, cGMP layout approach, and manufacturing operations strategies.

CHEP9007 Analytical Technology Transfer:

This module presents the formal analytical process of transferring analytical methodologies, & their associated technology, in heavily regulated life science environments such as pharmaceutical & biopharmaceutical industries. This module targets analytical methods and technology in terms of lifecycle, transition from Research and Development to product launch at the manufacturing facility. 

CHEP9008 Facilities & Utilities:

This module explores pharmaceutical/biopharmaceutical facilities & utilities from a GMP compliance, mechanical and architectural perspective while also considering regulatory guidance and requirements. 

INTR9029 Technical Research Project:

This module facilitates the development of academic research skills with a view to progressing technical writing and research work presentation skills. These skills will be developed through application to an unstructured, complex problem or problems in an industrial context. The student will demonstrate their ability to develop and extend research, undertake research, propose recommendations, and develop conclusions. The research project will be a focused applied piece of work written in a targeted concise technical paper format for a technical audience.

Entry Requirements

Applicants who have a minimum of an Honours Bachelor of Science, Engineering or cognate degree (Level 8) or cognate discipline (H2.2) or equivalent from an accredited or recognised HEI provider or an approved qualification are eligible to apply for entry to the programme.

All applicants whose first language is not English must provide evidence of English language proficiency (IELTS score of at least 6.5 with no section below 6.0). English language tests must be undertaken no more than two years prior to the start of the programme. Full English Language Requirements are available at https://www.mtu.ie/international/non-eu/cork-campus/

Places are limited. Applications are assessed on a first-come, first-served basis.

What is RPL?

Recognition of Prior Learning (RPL) is when formal recognition is given for what you already know prior to starting on a programme or module. With recognition of prior learning the focus is on learning and not on experience as such. You can apply for RPL in any MTU accredited programme or module. Programmes which are accredited by professional bodies or any external awarding bodies may have their own procedures for RPL which you should refer to.

Fees

Course Fee: €10,000

Manageable fees & flexible payment schedule suited to those who are self-funding:

• €10,000 total (€833 per 5 ECTS credit module & €1667 per 10 ECTS credit module). Contact the MTU Fees Office at feescork@mtu.ie for further information.

Please note that applicants will be required to pay an acceptance fee of €500 online if a place on a course is offered. This fee is deductible from the overall course fee.

Note: You will not be charged for applying for the programme by clicking the "apply now" button; you are only asked to pay an acceptance fee if a place is offered to you and you wish to accept it.

Career options

Biopharmaceutical, Pharmaceutical, Med-Tech. Life science industries.

The program is designed to provide an industry-guided skillset and entry route to/for the field of GxP technology transfer in the life science manufacturing sector. It has two unique target streams:

1. To provide the necessary upskilling opportunities for existing employees already in the sector looking to move into multifunctional life science project teams. This includes existing scientific & engineering staff who may be experienced in the laboratory/production operations and routine commercial batch release who wish to progress into science & technology roles working more closely with R&D in bridging the transition to manufacturing. The role of the graduates could include Process Engineers, Principal/Senior Scientists and NPI Project Managers as examples.
2. To provide multidisciplinary skills necessary for the modern (Bio)pharmaceutical industry going forward, and so is relevant to graduates of cognate disciplines wishing to transition to this sector.