Senior Manager of External Manufacturing

• Location: Melbourne or Brisbane based
• WFH with occasional travel required to third party CDMO site in Melbourne
• One year contract (project based) with possibility to extend
• Reporting into the Translational Science Hub Project Lead, Australia

About the job

The Senior Manager of External Manufacturing will be responsible for CDMO management functions for the Technical Operations team, which includes helping to coordinate and drive activities for Sanofi’s mRNA Centre of Excellence programs via third party CDMOs for early phase production of clinical supplies. The ideal candidate will have significant relevant experience and a track record of accomplishments in the life sciences / pharmaceutical / biotechnology industry. This role is part of a global team focused on development and manufacturing of novel mRNA vaccines, for our Translational Science Hub (TSH) lead clinical trials.

Key aspects of this position include ensuring that our manufacturing processes and equipment are fit for purpose and that Drug Substance (DS), bulk Drug Product (bDP), and Finished Drug Product (FDP) and custom raw materials are manufactured and released through our CMO partners according to phase appropriate GMPs as needed to meet clinical demand. Assistance with the tech transfer activities to ensure accurate translation of the process requirements into CMO Batch Records and SOPs will also be a focus.

Additional responsibilities will include collaborating with the tech transfer and process scale-up and working with the Process and Analytical Development and Quality Assurance functional groups to provide manufacturing and technical support facilitating CMO issue resolution, deviation / investigation closure, and product disposition.

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

• Act as a primary liaison with CMOs to ensure product manufacturing meets demand requirements for drug substance (DS), bulk drug product (bDP), and finished drug product (FDP). Additionally, interact with third party suppliers that manufacture custom reagents, raw materials, consumables, and custom single use components / assemblies for Sanofi’s products. Both scopes of activities will include communicating production demand planning to the CMO, Person-in-Plant activities, executed batch record review and issue resolution, deviation / investigation support and closure, preparation of campaign summary reports, and support of final product disposition as needed by QA.
• Manage CMC aspects of both internal and external projects.  Organize and facilitate Gantt charts and manage timelines, particularly critical path items.  Develop and maintain project charters, RACI matrices, Action Item trackers and resource trackers.
• Lead internal project team through issuing meeting agendas, facilitating regularly scheduled meetings, issuing minutes, tracking action items, etc.  Control and track information exchange with other internal groups and external collaborators as needed.
• Assist with the tech transfer activities from Sanofi to CMO partners. This includes ensuring accuracy of the process description, review of Master Batch Records and SOPs for alignment with the process description, review of material specifications, review and approval of raw material / consumables procurement plans, and coordination with Analytical Development on analytical method transfer, qualification, and validation.
• Act as a liaison with Supply Chain to ensure raw material supplies meet demand needs for drug substance, bulk drug product, and fill/finish manufacturing operations.
• Work with Process Engineering to provide support for tech transfer and process scale-up activities.  Assistance with hands-on execution of process development activities and demonstration batches may also be required.

About you

• Tertiary qualifications in a relevant field e.g. Engineering, Life Sciences etc.
• 12+ years of relevant GMP manufacturing, process development or quality assurance experience in the biopharmaceutical industry.
• Experience with process / technology transfer and CMO management.
• Experience in technical / process development and process / technology transfer as well as GMP manufacturing, focused on biologics or ATMPs.
• Demonstrated success in managing multiple projects effectively. Highly organized, exceptional attention to detail and strong proficiency in documentation skills.
• Knowledge and understanding of biopharmaceutical laboratory terminology, documentation, laboratory practices and manufacturing practices.
• Experience and demonstrated proficiency in global GxPs, industry guidance (esp., ICH Q6 – Q12) and compliance with the same.
• Experience with leading project team meetings, cross-functional communication, supporting decision making, influencing outcomes, and ensuring alignment among internal and external stakeholders.
• Familiar with current issues and regulatory requirements related to manufacturing using single use equipment for drug substance and drug product production 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

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