Posted: 7 March 2023
Medicines Development for Global Health develops medicines and vaccines for neglected diseases. Our approach is to bring together the ideas of researchers with our development expertise and passion to develop new products that will be life changing for millions. We are a non-profit company – all funds in excess of expenses are devoted to this purpose.
Our team brings a depth of expertise from within the pharmaceutical and global health sectors in clinical studies, project management, pharmaceutical development and regulatory submissions. With the expansion of our product portfolio and increasing number of neglected disease programs kicking off or expanding activities, we are looking for an experienced Chemistry Manufacturing and Controls (CMC) manager to join our team and dive into every aspect of activities to support project aims.
As a key member of our CMC operations team, you will be responsible for the development and implementation of CMC strategies for Medicines Development for Global Health products, spanning early development through to product registration. You will be the CMC representative on at least one selected drug development project team, ensuring CMC activities align with development project milestones and timelines, providing advice and support on complex CMC operations issues in conjunction with the broader CMC team and pushing onwards to resolve them. Some of your responsibilities include:
• developing (as applicable for experience level) and implementing long and short-term CMC strategies for allocated MDGH products/projects;
• managing developmental and/or commercial phase manufacture and packaging process development, scale-up and technology transfer activities with internal team members and outsourced providers and consultants, including all aspects of vendor management and CMC budgeting for your project(s); • coordinating CMC activities to provide drug substance, drug product and/or investigational products for program studies/trials; and
• generating quality and technical documents to support quality and regulatory compliance, ensuring CMC activities are compliant with regulatory requirements and support the preparation and filing of regulatory submissions.
You will have extensive experience in CMC project management and technical operations in the biotechnology/pharmaceutical industry, including vendor management. This will include a deep knowledge of Good Manufacturing and Laboratory Practices. You will be an outstanding activity manager and communicator, with excellent technical writing skills. Our ideal candidate will be energised by the opportunity to work in a cross-functional team to identify risks and their possible solutions, find outside the box options, deliver activities on time and on budget and will bring resourcefulness, ownership and a flexible team approach to this role. A degree in a relevant science discipline is essential, with organic chemistry highly desirable. For optimal teamwork, a Melbourne based team member is preferred for this role, but candidates in other locations will also be considered.
This is a great opportunity to join a friendly, inclusive team committed to making a difference. We put people first, with a strong focus on employee well-being and professional growth and development.
MDGH is a place where everyone has a voice. We pride ourselves on our teamwork and openness, both with our staff and in our relationships with our partners, study participants, and other like-minded organisations where we share ideas and information to advance global health equity. We champion diversity, inclusion and equality, and encourage talented people from all backgrounds, abilities and identities to apply.
We are a work anywhere company, which means you can choose to work in the environment that works best for you to get the job done. We offer a competitive market-based salary package tailored to country of residence including fringe benefits which are tax exempt for Australian based staff.
Please email your resume and short cover letter to Narelle Mahony, Executive Assistant at email@example.com or call Nicky Konstantopoulos on +61 3 9912 2405 for more information about the role.