Easter Seals Jobs

Location: Brisbane

Reporting into the Translational Science Hub Project Lead, Australia

About the job

The External Manufacturing Project Manager will be responsible for project management functions within the mRNA Centre of Excellence, primarily focused on management of Tech Transfer and Manufacturing of early stage clinical materials for our Translational Science Hub clinical trials in Australia.

This role will support the External Manufacturing & Manufacturing Sciences team by leading sub teams composed of cross-functional representatives from within and external to the mRNA CoE.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main responsibilities

• Support the External Manufacturing team in leading cross-functional sub teams to develop plans and execute Tech Transfer and Manufacturing of early stage clinical mRNA based products.

• Collaborate with multi-disciplinary team members to analyze/optimize development approaches and to develop detailed integrated operational project plans to achieve the project milestones. Support resource planning and allocation (i.e. via RDPM) and cost planning activities.

• Coordinate creation and issuance of purchase orders for Tech Transfer, Manufacturing, and procurement of Raw Materials and Consumables at the CMO. Track CMO invoices against POs.

• Apply project management expertise and best practices in the planning, initiation, execution and tracking of project activities. With internal stakeholders and the CMO develop and maintain detailed project schedules to track progress against key project deliverables.

• Lead regularly scheduled sub team meetings to track activities, monitor progress, drive decision making, resolve issues, and identify / track risks and mitigation plans. Facilitate meetings through issuance of meeting agendas and minutes and tracking / follow up of action items.

• Proactively monitor project progress and provide timely communications to the mRNA CoE Leadership Team, and to other key stakeholders regarding project status, critical path activities, resource requirements, and risks and mitigation strategies via weekly status reports / project dashboards.

About you

• Tertiary qualifications in a relevant field e.g. chemical, biomedical, biochemical or process engineering, chemistry, materials sciences or formulation sciences, etc.

• 8+ years of relevant experience in the biopharmaceutical industry, coupled with an understanding of analytical chemistry and typical CMC activities and requirements.

• Knowledge of typical CMC activities and requirements.

• Demonstrated success in managing multiple projects effectively and using project management tools.

• Knowledge of and experience with implementing Agile/Scrum methodologies.

• Knowledge and understanding of laboratory terminology, good documentation, and good laboratory practices.

• Experience and demonstrated proficiency in global GxPs, industry guidance (esp., ICH Q6 – Q12) and compliance with the same.

• Demonstrated ability to facilitate project team meetings, enhance cross-functional communication, support decision making, influence outcomes and ensure alignment among internal and external stakeholders.

• PMP certification would be an advantage.

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognises your contribution and amplifies your impact.

• Take good care of yourself and your family with benefits including, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave

#LI-ANZ

Pursue progress , discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)

As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.

All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)