Job Title

Senior Manager/ Associate Director A&ST QCMelbourne, Australia | full time | Job ID:9057BioNTech is establishing an mRNA research and manufacturing facility in Melbourne based on its modular mRNA manufacturing approach called BioNTainer 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. As Associate Director of QC you will assist in the setting-up and management of state-of-the-art QC Chemistry, Microbiology and AS&T laboratories (including laboratory design and equipment qualification), QC processes and procedures (i.e., raw material/product testing and releasing, method qualifications, validations, verifications and transfers), and the QC department (Chemistry, Microbiology and AS&T) and supervisory staff.Your responsibilities are:Leading and managing the QC department (Chemistry and Microbiology) and supervisory staff.Leading and managing the AS&T team and supervisory staff.Supporting the testing and releasing of QC raw material and finished product.Supporting analytical method development and validation.Reviewing/approving QC and AS&T documents and records, as required.Ensuring QC Laboratory operations are compliant with GMP standards and constantly working to improve processes.Ensuring the QC department is audit ready at all times.Conducting random inspections and quality control checks.Providing cross-functional support with Quality Assurance (QA), Engineering (Eng), QC, and R&D teams to ensure seamless process integration.Providing support to the QC Director, as required.What you have to offer:University degree (preferably with a minimum of Honours) in relevant scientific discipline (e.g., Biology, Biochemistry, Chemistry, Microbiology or Pharmacy).+ 10 years of QC experience within a GMP regulated pharmaceutical laboratory.+ 3 years of leadership/management experience.Broad knowledge and practical experience of analytical sciences and technologies with prior experience in mRNA and/or nanoparticle-based formulations desirable.Significant experience in supporting the testing and releasing of QC raw materials and finished product.Significant experience supporting QC method validation and transfer activities.Significant experience working in cross-functional teams i.e., QA, Eng and R&D.Experience in hosting and collaborating with national or international regulatory agencies (i.e. TGA and FDA).Working knowledge of relevant local and international regulations.Strong supervisory and leadership skills.Employs strong analytical and problem-solving skills to manage shifting priorities, demands and timelines. Ability to identify problems, define problem statements clearly and drive resolution through sound and systematic application of technical knowledge. Innovative and effective in solution development, risk management, and execution.Working knowledge of relevant regulations and guidelines (experience with ICH, TGA, FDA, EMA, etc. are advantageous).Team player.Excellent verbal and written communication skills with the ability to train staff.Excellent organizational skills and attention to detail.Proficient with Microsoft Office Suite or related software.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. If you are considered for the position, BioNTech will conduct the background check through our service provider HireRight. You will be informed accordingly by your BioNTech-Recruiter.We are looking forward to receiving your application.Inspired? Become part of #TeamBioNTech. #J-18808-Ljbffr