This second Residency will allow students to develop enhanced skills related to working in BioPharma industry and provide deeper understanding of the standards and controls required for working in a highly regulated environment. The module will build on practical and professional skills for the student as they develop their professional portfolio. The student will embed in a team where they will contribute to, for instance, the development or testing of a process or method. The purpose is to provide a pathway towards more autonomy and agency. As before, for Residency 1, students will be matched with a host organization from the program's Industry Consortium, and matching will be managed directly by the Immersive Bioscience program. The iBio residency team will ensure that the experience for the student is complementary and additional to the experience of Residency 1. In most this cases will involve a residency in a different industry partner than the first residency and involvement in an incrementally advanced body of work. The envisaged matching timeline is as follows: ¿ Autumn semester Sept: submit applications to industry partners ¿ Autumn semester Oct: begin matching process ¿ Autumn semester Nov: interviews with industry partners, offers made and accepted ¿ Dec/Jan: buffer period ¿ Jan/Feb: residency 2 begins

The students will gain knowledge in critical aspects of the regulated working environment including: 1. CMC (Chemistry, Manufacturing and Controls) as related to the BioPharma industry 2. QRM (Quality Risk Management) for the BioPharma industry 3. QC (Quality Control) for the BioPharma industry 4. QA (Quality Assurance) for the Biopharm industry 5. Bodies regulating the BioPharma industry including the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) 6. Bodies providing advice to the BioPharma industry including International Council for Harmonisation (ICH), Parenteral Drug Association (PDA) 7. Sources of advice for the BioPharma industry including European Pharmacopoeia (Ph. Eur.), United States Pharmacopeia (USP) and the International Organization for Standardization (ISO) 8. Introduction to working in a GMP (Good Manufacturing Practice) environment 9. Introduction to QbD (Quality by Design) principles

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 that oversee the development of Biotherapeutics 2. Demonstrate knowledge of specific regulations regarding their project area 3. Demonstrate an understanding of where to find information regarding processes and regulations for key aspects of the manufacture of Biotherapeutics 4. Demonstrate knowledge of the internal interactions between different sections of their residency mentor company, for instance be able to explain how QC and QA interaction with product manufacturing, and explain the role of TS/MS (Technical support/Manufacturing support) 5. Demonstrate an understanding of the rigors of a GMP workplace 6. Create data and criterion for decision making relating to protocols and processes which assist teams in helping their roadmap projects. 7. Propose or implement (as appropriate) small scale corrective and/or adaptive changes to a protocol or a process. 8. Demonstrate an understanding of and apply SOPs (Standard Operating Procedures) of intermediate 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: 1. Perform experimentation in a safe and professional manner in a regulated environment 2. Execute donning of PPE (Personal Protective Equipment)

Student experience Each student will be embedded in the team of their technical mentor. This means that they will not only work on their own projects, but will also 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. 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. The technical mentor will supervised the daily practical activities. Additional specialist mentors will provide weekly information sessions on the non-practical aspects of the work, for instance explain the role of QC in BioPharma. Residencies are not simply pass/fail, and have specific learning outcomes that students will be evaluated against. Students will maintain a "logbook" that tracks their progress on these 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) evaluation by industry mentor. Students in the same residency sequence will be divided into groups of 4-6 and assigned an academic advisor for the group. These groups will have at most 2 students from the same company, and will be called Residency Peer Groups. Residency Peer Groups will have weekly guided discussions, comparing and contrasting scientific or engineering approaches. These meetings will not have host company employees present so that students can speak freely and ask for help with challenging situations. Additionally, students will be placed with host companies in groups of at least 2, in order to facilitate peer learning and support. 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 Residency 2 two models of project are envisaged. 1. Mentor-driven tasks In a mentor-driven task residency, the tasks are primarily defined by the mentor, or sometimes by the mentor's team mates. An example of the scope of a Mentor-driven project includes 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, including safety training Week 2: Reading SOPs (Standard Operating Procedures) Weeks 3-14: Completion of specified tasks Week 15: conference prep + reflective essay 2. Mentor-given project Some residencies will focus on the student's ability to take a larger project and break it down into smaller parts. In this case, they rely less on the mentor for project management, since part of the goal is for the student to take a large project with unknowns and break it down into smaller sections. An example of the scope of a Mentor-given project includes method optimization, systematic development of a process or data based projects. The first week or two of their residency may be writing design docs and circulating them for feedback (filling in time with spin-up tasks from the mentor). Students are also expected to spend time documenting their task at the end of the residency. Before the student arrives, the technical mentor should scope a project for ~5 weeks of work (expected to take 10 weeks for the student). Week 1: spin up tasks, including safety training Week 2-3: project understanding + breakdown; reading SOPs Weeks 4-14: sprinting through milestones. Week 15: hand-off doc for team, documentation, conference preparation