Associate Director Cmc

Become a member of the BioNTech Family!

As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards - writing medical history.

We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.

Associate Director* CMC

BioNTech 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 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. You will also 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 main 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.
• 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.
• 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.
• Brings a positive, can-do attitude with the ability to succeed in a fast-paced work environment.
• Demonstrates sound judgment in collecting and synthesizing relevant data and information; communicates, influences, and escalates issues and decisions as needed.
• Takes accountability for actions, drives results, learns from mistakes. Is direct and truthful and therefore widely trusted - delivers promises, goals, and expectations. Makes quality decisions and resolves problems rapidly. Asks "what can I do to help?"

Benefits for you:

We offer a competitive compensation package which will be determined by the contract type and selected candidate's qualifications and experience.

How to apply:

Apply now and simply send 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 by using our online form.

Please note:

• Only applications sent via our online form shall be considered.
• Only Candidates with the right qualifications and relevant experience shall be shortlisted and
• Incomplete applications shall be rejected.
• Please note that BioNTech will run a background check during the hiring process

We are looking forward receiving your application.

• BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important - it's a match!

BioNTech - As unique as you

www.biontech.com