Job Title

Melbourne, Australia | full time | Job ID:9059BioNTech is establishing an mRNA research and manufacturing facility in Melbourne based on its modular mRNA manufacturing approach called BioNTainers that will support R&D and the evaluation of mRNA vaccine candidates in clinical trials in Australia, with the aim of strengthening Australias mRNA ecosystem. The Production Manager will be responsible for supporting the operational readiness of the site including the development and execution of work packages for Drug Substance (DS), Drug Product (DP), and Fill/Finish operations. The role will also provide crucial support to validation and Manufacturing Science & Technology (MST) during the ramp-up phase, with a focus on sterile manufacturing processes.Your responsibilities are:Lead the development and execution of work packages for DS, DP, and Fill/Finish operations during operational ramp-up.Lead and manage the manufacturing staff.Ensure training of staff according to training plans and continue to develop team competencies.Drive safety and quality culture of the staff.Ensure production processes are compliant with GMP, focusing on sterile manufacturing practices.Ensure GMP inspection readiness of the team. Lead / participate actively in quality audits and inspections.Manage and mitigate key operational, contamination control, and other quality risks of operations.Oversee the operationalization of systems and processes to ensure timely production ramp-up.Support process and knowledge transfer to the BioNTainer manufacturing site with a focus on continuous improvement and productivity.Collaborate with the validation and MST teams to ensure smooth process validation and troubleshooting during ramp-up.Coordinate cross-functional support with QA, Engineering, QC, and R&D teams to ensure readiness for full-scale production.What you have to offer:University degree in relevant field (desired).+ 8 years of operational manufacturing working experience in bio-pharmaceutical environment.+ 3 years of people management experience.Strong experience in GMP production, particularly in sterile environments.Experience with drug substance and/or drug product manufacturing, technology transfers, process validation and risk assessments.Expertise in operational readiness developing and executing work packages for DS, DP, and Fill/Finish processes.Experience with collaborations with global multidisciplinary functions involved in technology transfer and manufacturing.Good knowledge in digital tools used in manufacturing environment (MES, automation systems etc).Strong understanding of regulatory and legal requirements (i.e. TGA and FDA).Cross-functional collaboration with QA, Engineering, QC, and R&D teams.Strong solution-driven mindset and desire to learn.Ability to conceptualize, analyze, plan and manage in a fast-paced environment.Ability to be agile, effectively collaborate, and build consensus in a dynamic, cross-functional environment.Excellent interpersonal skills; outstanding communication skills (verbal and written).How to apply:Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.Please note: Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations.We are looking forward to receiving your application.Inspired? Become part of #TeamBioNTech. #J-18808-Ljbffr