Module Code - Title:
BY4213
-
IMMERSIVE BIOSCIENCE RESIDENCY 1
Year Last Offered:
N/A
Hours Per Week:
Grading Type:
N
Prerequisite Modules:
Rationale and Purpose of the Module:
This block is the first in a series of 5 Residencies that the students of Immersive Bioscience will undertake during the first 3 years of the course. This initial residency introduces students to the complexity of the Biologics industry, and the challenges associated with working in a regulated environment. These challenges range from providing support to localized teams with a specific task through to working within a globally distributed multi-disciplined matrix team. The student will learn about the organization's structure, culture, management, and the variety of roles fulfilled by team members. The student will contribute to the functioning of a specific team through performance of an agreed set of practical project tasks.
Under the joint supervision of academic and industry mentors 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.
Industry mentors
On each residency, each student will have two mentors from their host company; a technical mentor, who will guide them through the process of training and team integration at their host company; and a pastoral line manager, who will be responsible for their overall experience, including for helping to resolve challenges that the student faces. They will meet with their technical mentor daily, and their line manager weekly. The time commitment anticipated for the technical mentor will be approximately 15 hours per week (although this will likely decrease as the residency progresses), and approximately 1.5 hours per week for the line manager. Both mentors will receive UL-created training before the start of the residency to ensure that they understand the iBio course and what their responsibilities are.
Eligibility: both mentors will be high performing scientists or engineers within the host company. We expect that most will have at least 4 years experience in the field of Biologics production, as well as at least a BSc in Science or a related field. Exceptions to these requirements can be made on a case-by-case basis. The host company must be able to attest that the mentors will be capable of providing excellent support and guidance for the entire duration of the residency.
Training for Industry Mentors: mentors will be required to complete an online course that provides insight in supporting teaching and learning in a collaborative context, for example, the UL Moderating Online Environments course delivered by the Centre for Teaching and Learning. Webinars on European Credit Transfer System (ECTS) and learning outcomes will be presented where attendees will be asked to design a residential model.
Mentors will receive training on reporting requirements for both mentor and student that collectively documents the resident's progress toward the learning outcomes and professional practice.
Student/host matchmaking
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 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 envisaged matching timeline is as follows:
¿ Autumn semester Sep-Dec: CV preparation, interview practice
¿ Spring semester Jan: submit applications to industry partners
¿ Spring semester Feb: begin matching process
¿ Spring semester Mar: interviews with industry partners, offers made and accepted
¿ Apr/May: buffer period
¿ Jun: residency 1 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.
Syllabus:
We envisage three models of residencies: mentor-driven tasks, mentor-given project, and student-selected project. Which model is most appropriate for a given residency will depend on the residency's learning outcomes and in-depth discussions with partner companies. For Year 1 and Year 2 residencies the mentor-driven tasks and mentor-given projects are appropriate.
1. Mentor-driven tasks
In a mentor-driven task residency, the tasks are typically small and are primarily defined by the mentor, or sometimes by the mentor's team mates. Most days consist of support activities such as sterility testing, solution preparation, sample taking, spectroscopic testing and reporting back to the team. Students are mostly treated as very inexperienced team members.
Timeline:
Week 1: spin up tasks, including safety training
Week 2: Reading SOPs
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. The student may or may not be operating on the same scheduling cadence as the rest of their team. 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
In the Year 1 Residency the student will be exposed to a regulated working environment and will learn about the rigors of working in a regulated environment. Over the course of the 5 residencies the students will gain knowledge of 3 different classes of biotherapeutics from a panel of possible therapeutics including monoclonal antibodies, antibody-drug conjugates, tetherbodies, cell and gene therapies, enzyme replacement therapies, synthetic peptides, biologics and biosimilars. The portfolio of knowledge each student gains will be monitored by the iBio Residency team.
Practical work for students in their first residency will be commensurate with their experience. They will be expected to make an active contribution to a team.
The scope of project work for Year 1 students will be Residency host dependent but will be from a panel of tasks including but not limited to:
1. Supporting Quality Risk Management including Appendix 1 activities (Microbiological aspects) and Failure modes and safety testing
2. Testing and investigating Host Cell Protein contamination (using immunological based assays - ELISAs)
3. Endotoxin monitoring
4. Supporting Quality Control activities such as sample taking and solution preparation for techniques such as HPLC
5. Data analysis (introductory level)
Learning Outcomes:
Cognitive (Knowledge, Understanding, Application, Analysis, Evaluation, Synthesis)
On successful completion of this module, students will be able to:
1. Document changes as mandated by the organization's standards
2. Describe the organizational structure and culture
3. Describe the workflow of the process they are involved in
4. Identify the roles played by team members in the organization. For example, specialist technical staff, scientists, technical leads and project managers, and others.
5. Implement a simple Standard Operating Procedure (SOP) to a professional level
6. Research and deliver a webinar on a residency topic: A 15-30 minute presentation that would appear in an industry conference/internal company tech talk.
Affective (Attitudes and Values)
On successful completion of this module, students will be able to:
1. Update line managers as instructed and notify them of issues in a timely and precise manner.
2. Adhere to schedules set out by team leads and project managers
3. Respect and fully comply with all of the tiered-industry partner's codes of conduct
4. Comply fully with NDAs and contracts
5. Convey a professional manner at all times
6. Present work in a precise and cohesive manner
7. Appreciate the rigors of working in a regulated environment
Psychomotor (Physical Skills)
On successful completion of this module, students will be able to:
How the Module will be Taught and what will be the Learning Experiences of the Students:
Student Capability
By the time the student begins their first residency, they will have studied theory and practical lab skills for two semesters and will be familiar with residency-relevant topics such as:
• Aseptic technique
• Microbial cell culture
• Solution preparation
• Electrophoresis
• UV/Vis Spectroscopy
• Filtration techniques
• Reading and following SOPs
• Good Laboratory Practice
• Lean working environment
• Basic data science and data analysis
• Professional practice
This knowledge will allow students to be comfortable and productive in their first residency. They will be able to participate in the day-to-day activities of their host team. They will understand the processes by which their team's work is organized, and the fundamentals of the methods that they are expected to work with generating knowledgeable and curious graduates.
In the rest of this description (the first residency), we present information that will also apply to subsequent residencies.
Industry Partners
Companies will be recruited onto the industry consortium based on the following characteristics:
Tier 1: BioPharma multinationals with commitment to iBio concept, expert mentor panel, capacity, track record in Biologics production
Tier 2: Domain specific multinationals with a strong Life Science focus, e.g. BioPharma, Diagnostics, & Pharma
Tier 3: Start-ups in the Life Science sector led by innovators with a proven track record
Tier 4: SMEs with an appropriate focus relating to Life Science
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 generating agile graduates. 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 generating knowledgeable graduates.
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 generating articulate and knowledgeable graduates. 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.
Research Findings Incorporated in to the Syllabus (If Relevant):
Prime Texts:
Other Relevant Texts:
Programme(s) in which this Module is Offered:
Semester(s) Module is Offered:
Summer
Module Leader:
Jakki.Cooney@ul.ie