Associate Director CMC

Melbourne, Australia   |   full time   |   Job ID: 9060 

BioNTech 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 Australia’s mRNA ecosystem.  In this exciting role, you will partner with external ecosystem partners and the Research Production Hub team to support the transition of projects from research production into GMP manufacturing for clinical trial supply and develop and implement processes for the manufacture and QC testing of mRNA-based vaccines and their nanoparticle-based formulations with the goal of ensuring the timely and efficient delivery of high-quality products to clinical trials.

Your responsibilities are:

• Develop and oversee implementation activities related to the GMP manufacture, formulation and QC testing of mRNA vaccine candidates for clinical trials.   
• Support process and knowledge transfer to the BioNTainer manufacturing site with a focus on continuous improvement and productivity. 
• Manage CMC activities and plans to address client’s needs in a timely and effective manner. 
• Manage CMC operational activities for clinical drug product development and manufacturing e.g. assessment of critical quality attributes, critical process parameters, in-process controls, process validation, starting material and drug product quality and characterization, reference standards, stability studies etc. 
• Identify, develop and implement CMC related processes and overall process improvement initiatives to optimize operational efficiencies. 
• Collaborate with the MST teams to ensure smooth process validation and troubleshooting during ramp-up. 
• Coordinate internal and external development tasks towards development and production of products for pharmaceutical use in compliance with GMP. 
• Engage with key stakeholders to ensure transparency on program status and alignment on program plans, goals, resource requirements and timelines. 
• Be responsible for authoring and/or reviewing technical reports, work instructions, and risk assessments to support process development and implementation at manufacturing site(s). 
• Represent CMC development in project teams, contribute to the development of detailed CMC project plans and overall program plans.

What you have to offer:

• PhD in Biological Sciences, Biochemistry, Biochemical Engineering, Pharmaceutical Development or related field, or master's degree plus additional years of professional experience. 
• A minimum of 8+ years of cross-functional CMC experience in process development and/or manufacturing support in the biopharmaceutical industry including experience supporting the transition of programs from research into GMP manufacturing for clinical trials. 
• Prior experience with support of drug substance and/or drug product manufacturing, technology transfers, process validation and risk assessments with experience in international technology transfers desirable. 
• Prior experience in the manufacture, QC testing and characterization of nucleic acid-based vaccines and their formulation with experience in mRNA manufacturing, formulation, or characterization desirable. 
• Prior experience in the CMC project management – demonstrated track record of project planning, execution, and tracking. Demonstrated aptitude for successfully managing multiple projects, of varying complexity within the specified guidelines, timeframes, and budgets.

• Strong technical and people leadership skills including ability to be agile and effectively collaborate in a dynamic, cross-functional environment with internal and external stakeholders. 

• Ability to communicate effectively up and down, at all levels of the organization, present complex and/or new ideas with clarity and simplicity. 

• Ability to work in an international team understanding cross-cultural perspectives for technical transfer of processes from Germany. 

• Exceptional analytical and problem solving skills

What we do with the BioNTainers:

We want to improve healthcare by making our innovations accessible worldwide. Therefore, we developed the first modular mRNA-manufacturing facilities based on a container solution called “BioNTainers”. Help us build a regional manufacturing network in Africa & Australia: With the region and for the region. As a part of the local team, driving the establishment of the regional end-to-end mRNA manufacturing solutions.

Benefits for you:

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.

Click here to find out more about what we do, the careers we offer ans also the benefits we provide. Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.

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 receiving your application.