Students

MOLS8904 – Biotechnology Management: Quality, Strategy and Innovation

2026 – Session 1, Online-flexible, North Ryde

General Information

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Unit convenor and teaching staff Unit convenor and teaching staff Unit convenor
Anwar Sunna
Contact via email
14EaR202
Monday to Thursday - by appointment
Unit convenor
Koushik Venkatesan
Contact via email
Credit points Credit points
10
Prerequisites Prerequisites
Corequisites Corequisites
Co-badged status Co-badged status
Unit description Unit description

This unit provides students with industry-focused, practical skills in management, quality assurance, and commercialisation within the biotechnology sector. Through a self-paced, blended learning approach featuring real-world case studies, industry insights, and project-based activities, students will gain practical understanding of management practices, quality systems, and commercialisation strategies specific to the biotech industry.

Students will work in teams to create a comprehensive business plan for a hypothetical biotech company, covering aspects such as team leadership, quality management systems, and commercialisation frameworks. The unit culminates in a "Shark Tank" style pitch, where students present their plans to an industry-led panel for constructive feedback. This hands-on approach equips graduates to apply key skills in biotechnology management, quality assurance, and innovation in real-world biotech contexts.

Important Academic Dates

Information about important academic dates including deadlines for withdrawing from units are available at https://www.mq.edu.au/study/calendar-of-dates

Learning Outcomes

On successful completion of this unit, you will be able to:

  • ULO1: Analyse core principles of quality management in biotechnology contexts
  • ULO2: Evaluate strategies for commercialising biotechnology innovations
  • ULO3: Design quality management systems for biotechnology processes
  • ULO4: Formulate commercialisation plans for biotechnology products
  • ULO5: Evaluate management practices in biotech companies
  • ULO6: Collaborate effectively within a team to develop and present comprehensive management, quality, and commercialisation strategies in a biotechnology context.

General Assessment Information

A. Requirements to Pass this Unit

To pass this unit you must achieve a total mark equal to or greater than 50%.

B. Late Assessment Submission Policy

5% penalty per day: If you submit your assessment late, 5% of the total possible marks will be deducted for each day (including weekends), up to 7 days.

  • Example 1 (out of 100): If you score 85/100 but submit 20 hours late, you will lose 5 marks and receive 80/100.
  • Example 2 (out of 30): If you score 27/30 but submit 1 day late, you will lose 1.5 marks and receive 25.5/30.

After 7 days: Submissions more than 7 days late will receive a mark of 0. Extensions:

  • Automatic short extension: Some assessments are eligible for automatic short extension. You can only apply for an automatic short extension before the due date.
  • Special Consideration: If you need more time due to serious issues and for any assessments that are not eligible for Short Extension, you must apply for Special Consideration.
  • Need help? Review the Special Consideration page HERE

Late submissions will be accepted for: 

  • Assessment 1. Management and Quality Management Plan
  • Assessment 2. Commercialisation Strategy, which are written tasks with a specified due date.

C. Special Consideration

The Special Consideration Policy aims to support students who have been impacted by short-term circumstances or events that are serious, unavoidable and significantly disruptive, and which may affect their performance in assessment. If you experience circumstances or events that affect your ability to complete the assessments in this unit on time, please inform the convenor and submit a Special Consideration request through https://connect.mq.edu.au.

Assessment Tasks

Name Weighting Hurdle Due Groupwork/Individual Short Extension AI Approach
Management and Quality Management Plan 30% No 03/04/2026 Individual and Group Yes Open
Commercialisation Strategy 30% No 08/05/2026 Individual and Group Yes Open
Client Presentation 40% No Week 12-13 Individual and Group No Observed

Management and Quality Management Plan

Assessment Type 1: Professional task
Indicative Time on Task 2: 35 hours
Due: 03/04/2026
Weighting: 30%
Groupwork/Individual: Individual and Group
Short extension 3: Yes
AI Approach: Open

You will work in a group to develop a Management and Quality Management Plan for a fictitious biotech company. Your group will submit a plan that includes the management structure, quality assurance processes, and risk analysis. Individually, you will also submit a reflection detailing your contributions to the plan and use of generative AI. The group plan and your individual reflection will be submitted at the same time.


On successful completion you will be able to:
  • Analyse core principles of quality management in biotechnology contexts
  • Design quality management systems for biotechnology processes
  • Evaluate management practices in biotech companies
  • Collaborate effectively within a team to develop and present comprehensive management, quality, and commercialisation strategies in a biotechnology context.

Commercialisation Strategy

Assessment Type 1: Written Submission
Indicative Time on Task 2: 35 hours
Due: 08/05/2026
Weighting: 30%
Groupwork/Individual: Individual and Group
Short extension 3: Yes
AI Approach: Open

You will work in a group to prepare a Commercialisation Strategy for a fictitious biotech product. Your group will begin with an AI-generated draft that will need to be enhanced to include intellectual property planning, market analysis, regulatory considerations, and a market entry strategy. 


On successful completion you will be able to:
  • Evaluate strategies for commercialising biotechnology innovations
  • Formulate commercialisation plans for biotechnology products
  • Collaborate effectively within a team to develop and present comprehensive management, quality, and commercialisation strategies in a biotechnology context.

Client Presentation

Assessment Type 1: Presentation task
Indicative Time on Task 2: 20 hours
Due: Week 12-13
Weighting: 40%
Groupwork/Individual: Individual and Group
Short extension 3: No
AI Approach: Observed

You will work in a group to present the Commercialisation Strategy in a 'Shark Tank' style panel presentation. You will be assessed on the effectiveness of your communication of key elements of the strategy. You will also complete a peer assessment of your group members' contributions. The presentation and your peer assessment will be submitted at the same time.


On successful completion you will be able to:
  • Analyse core principles of quality management in biotechnology contexts
  • Evaluate strategies for commercialising biotechnology innovations
  • Design quality management systems for biotechnology processes
  • Formulate commercialisation plans for biotechnology products
  • Evaluate management practices in biotech companies
  • Collaborate effectively within a team to develop and present comprehensive management, quality, and commercialisation strategies in a biotechnology context.

1 If you need help with your assignment, please contact:

  • the academic teaching staff in your unit for guidance in understanding or completing this type of assessment
  • Academic Success for academic skills support.

2 Indicative time-on-task is an estimate of the time required for completion of the assessment task and is subject to individual variation.

3 An automatic short extension is available for some assessments. Apply through the Service Connect Portal.

Delivery and Resources

A. Delivery

This unit is delivered through a self-paced, blended learning model supported by the unit convenors. Learning materials include recorded lectures, with most presentations provided by industry contributors, together with guided activities and applied project work.

There are no scheduled weekly lectures. Instead, a small number of update or consultation meetings may be scheduled during the semester at times convenient for students. All learning materials, activities, and communication are provided through iLearn.

Group-based learning and simulated biotechnology context

This unit uses a group-based learning approach built around a simulated biotechnology industry context. Students will form their own groups early in the teaching period and will work together throughout the unit as a fictitious biotechnology company. Each group will be required to:

  • Propose and agree on a company name
  • Define a fictitious biotechnology product
  • Operate within a simulated biotechnology management structure, including role-play of professional positions typically found in biotechnology companies (for example, management, quality, regulatory, or commercial roles)

Group sizes will depend on enrolment numbers and will be confirmed prior to the start of the teaching period. Group formation details and expectations will be communicated via iLearn.

Through this structure, students will engage in authentic role-based decision-making, collaborative planning, and applied problem-solving that reflect real-world biotechnology management environments. All major assessment tasks are aligned with this simulated company framework and require coordinated group input alongside individual reflective components.

This unit comprises three integrated modules:

Module 1: Management Practices in Biotechnology

  • Lecture 1: Introduction to Biotechnology Project Management
  • Lecture 2: Leadership and Team Management in Biotechnology
  • Lecture 3: Financial Planning for Biotechnology Companies
  • Lecture 4: Case study

Module 2: Principles of Quality Management in Biotechnology

  • Lecture 1: Introduction to Quality Management Systems (QMS)
  • Lecture 2: Regulatory Frameworks in Biotechnology
  • Lecture 3: Quality Management
  • Lecture 4: Project Management: Risk Management

Module 3: Commercialisation Strategy for Biotechnology

  • Lecture 1: Phases of Commercialising a Biotechnology Product
  • Lecture 2: Intellectual Property Strategies in Biotechnology
  • Lecture 3: Regulatory Pathways to Market Approval in Biotechnology
  • Lecture 4: Go-to-Market Strategies and Lifecycle Management
  • Lecture 5: Case study  

B. Methods of Communication

We will communicate with you via your university email and through announcements on iLearn. If you have queries for the unit convenor, you can: 

  • Post your question on the iLearn discussion board (preferred for general queries that may benefit other students)
  • Send a private message to the unit convenor via iLearn

Please check your university email and iLearn regularly to ensure you do not miss important updates.

Policies and Procedures

Macquarie University policies and procedures are accessible from Policy Central (https://policies.mq.edu.au). Students should be aware of the following policies in particular with regard to Learning and Teaching:

Students seeking more policy resources can visit Student Policies (https://students.mq.edu.au/support/study/policies). It is your one-stop-shop for the key policies you need to know about throughout your undergraduate student journey.

To find other policies relating to Teaching and Learning, visit Policy Central (https://policies.mq.edu.au) and use the search tool.

Student Code of Conduct

Macquarie University students have a responsibility to be familiar with the Student Code of Conduct: https://students.mq.edu.au/admin/other-resources/student-conduct

Results

Results published on platform other than eStudent, (eg. iLearn, Coursera etc.) or released directly by your Unit Convenor, are not confirmed as they are subject to final approval by the University. Once approved, final results will be sent to your student email address and will be made available in eStudent. For more information visit connect.mq.edu.au or if you are a Global MBA student contact globalmba.support@mq.edu.au

Academic Integrity

At Macquarie, we believe academic integrity – honesty, respect, trust, responsibility, fairness and courage – is at the core of learning, teaching and research. We recognise that meeting the expectations required to complete your assessments can be challenging. So, we offer you a range of resources and services to help you reach your potential, including free online writing and maths support, academic skills development and wellbeing consultations.

Student Support

Macquarie University provides a range of support services for students. For details, visit http://students.mq.edu.au/support/

Academic Success

Academic Success provides resources to develop your English language proficiency, academic writing, and communication skills.

The Library provides online and face to face support to help you find and use relevant information resources. 

Student Services and Support

Macquarie University offers a range of Student Support Services including:

Student Enquiries

Got a question? Ask us via the Service Connect Portal, or contact Service Connect.

IT Help

For help with University computer systems and technology, visit http://www.mq.edu.au/about_us/offices_and_units/information_technology/help/

When using the University's IT, you must adhere to the Acceptable Use of IT Resources Policy. The policy applies to all who connect to the MQ network including students.


Unit information based on version 2026.03 of the Handbook