This 30 ECTS block is the first in a series of 3 Residencies that the students will undertake during the 3rd year of the course. Part 1 will be taken by all Immersive Bioscience students - both BSc and MSc level. Part 2 and 3 are taken by the MSc cohort only and form part of a year long residency. The three Yr3 residencies will form a continuum for MSc route students where Part 1 is an initial training and ramp up for the performance of preliminary investigations which will dovetail with a more substantial body of work in Part 2 and 3 of this year long (3 x 30 ECTS) residency. The student will contribute to the functioning of a specific team through performance of an agreed set of practical project tasks. Students on the BSc track will have the same basic set of objectives but the project work will be more limited in scope to give an outcome within the semester. By Residency 3 students will have had considerable experience and exposure to the different facets of the BioPharma industry including a 24 ECTS block focused on production and isolation of protein biologics. One of the key skills determinants in Biotherapeutics production is the distinction between upstream and downstream processes. Generally upstream is where living cells are used to make the active ingredient, whereas downstream is where the active ingredient is isolated and purified to homogeneity from the cells and complex growth media. The combination of the prior Residencies and the intensive on campus activities and training will give students skills in both spheres. The students will also have knowledge of the different classes of biotherapeutic - for example cell based, protein based and nucleic acid based. This knowledge will EMPOWER students to make a preferential decision regarding which of these main areas they are more interested in. The emphasis of their Residency will be set by their decision. Industry mentors The time commitment for the primary residency mentor will be initially 1-2 hours daily in the ramp up phase, reducing to 1-2 hours per week as the student gains independence. The eligibility criteria for mentors is the same as previous Residencies. Training for mentors will be the same as previous Residencies Student/host matchmaking Students will be matched with a project aligned with their area of interest offered by a host organization from the program's Industry Consortium, and matching will be managed directly by the Immersive Bioscience program. The Industry Consortium and the iBio program will have tight links, thus, it will be possible and desirable to perform the matching process by hand, with close contact between faculty, students, and organizations. The scientific interests of the student will be taken into consideration in the matching process and will roughly align with upstream and downstream The envisaged matching timeline is as follows: ¿ Spring semester Feb-April: discussions with students about their area of interest and discussion with industry partners as to scope of proposed projects ¿ Spring semester May: submit applications to industry partners ¿ Summer semester June: begin matching process ¿ Summer semester July: interviews with industry partners, offers made and accepted ¿ Aug: buffer period ¿ Sept: residency 3 begins As part of their agreement with the program, industry partners will commit to hosting at fixed number of placements per residency period ensuring that all students receive residency placements.

The students will expand their knowledge in critical aspects of the regulated working environment from study and experience of: 1. Standard Operating Procedures (SOPs) 2. Understanding change control in a regulated environment 3. Working in a controlled environment 4. Testing and maintaining sterility for Medicinal Products 5. Role of regulatory bodies in BioPharma

On successful completion of this module, students will be able to: 1. Demonstrate an understanding of and be able to explain the function of regulatory bodies 2. Demonstrate knowledge of specific regulations regarding their project area 3. Demonstrate an understanding of where to find specific information regarding processes and regulations for key aspects of their project 4. Demonstrate an understanding of controls relating to a GxP workplace 5. Devise appropriate aspects of a project plan 7. Propose or implement (as appropriate) corrective and/or adaptive changes to a protocol or a process. 8. Demonstrate an understanding of and be able to apply SOPs (Standard Operating Procedures) of sophisticated complexity

On successful completion of this module, students will be able to: 1. Convey a professional manner at all times 2. Present work in a precise and cohesive manner 3. Update line managers as instructed and notify them of issues in a timely and precise manner. 4. Adhere to schedules set out by team leads and project managers 5. Comply in full with all of the tiered-industry partner's codes of conduct 6. Comply fully with NDAs and contracts

On successful completion of this module, students will be able to: Demonstrate scientific ability through the correct performance of experimentation in a safe and professional manner.

Student experience Each student will be responsible for their work, giving the student AGENCY. The student will be embedded in the team of their technical mentor, & participate in the full activities of the team. They will attend meetings in which the team plans and evaluates its work, and coordinates with other teams producing COLLABORATIVE graduates. They will have the chance to talk to and learn from many scientists and engineers on their team, not just their technical mentor, as well as those across the rest of the organization generating ARTICULATE graduates. Specialist mentors will provide 1-2 hours weekly of professionalization training in the form of information about the regulatory bodies and framework guiding the BioPharma industry, for instance explain the audit process and the GMP work environment in BioPharma generating KNOWLEDGEABLE graduates. The students will participate in periodic, cohort-based webinars open to all partners that build up the student's PROFESSIONAL expertise in a systematic way. Student teams will present and discuss with the cohort the topics prepared since the previous seminar increasing CRITICAL THINKING. Students will maintain a "logbook" that tracks their progress on the learning outcomes. Faculty are ultimately responsible for grading, and will issue grades based on (a) the student logbook (b) quality of student led webinar produced as part of the residency and (c) a report evaluated in conjunction with the industry mentor. For Residency 3 three models of project are envisaged: 1. Mentor-driven tasks These projects are for those students completing the BSc route. In a mentor-driven task residency, the tasks are primarily defined by the mentor, or sometimes by the mentor's team mates. Example of Mentor-driven projects include: helping to lock-down a protocol, instrument validation or data analysis. Students are as part of the team and will attend meetings to present results. Timeline: Week 1: spin up tasks & safety training Week 2: Reading SOPs (Standard Operating Procedures) Weeks 3-14: Completion of specified tasks Week 15: Report writing 2. Mentor-given project These projects are suitable for students completing the BSc and MSc routes. Examples of Mentor-given projects include investigational studies, change control studies, method optimization, systematic development of a process or data based projects. For students on the BSc route a 15 week project is proposed by the mentor. For the MSc route, the technical mentor should scope a project which contains a substantial body of work proposed to engage the student for the year long residency. For Part 1 the timeframe is set out below to allow completion for BSc students or expansion for MSc students. Week 1: spin up tasks & safety training Week 2-3: project understanding + breakdown; reading SOPs Weeks 4-14: initial phase of project work. Week 15: compilation of initial report; expansion of project scope for Part 2 & 3 of the Residency. 3. Student-selected project For the MSc route, students may propose a project for completion within the Residency based on their own observations and critical thinking. These will be evaluated by the Industry partner for feasibility. The project should be a body of work with a defined goal and substantial data generated which is of use to the mentor team. The student should analyze the data generated in their work using appropriate statistical methods and data analytic tools. As these are only for MSc route a 12 month timeline is presented below Month 1: Spin up task + understanding the team; project scope in the working environment, writing and circulating documents setting out working details of the proposed project. Safety training and reading partners SOPs relating to proposed project. Month 2-11: Work on project, document, check in with team lead in a monthly cycle Month 12: Preparation of report, knowledge and data transfer to the team, conference presentation.