Director Quality Control

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.

Director* Quality Control

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:

• Build and lead a team of Quality Control (QC) professionals responsible for the set up and operation of QC laboratories in our new state of the art R&D production and clinical manufacturing facility.
• Support the 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.
• Be responsible for ensuring compliance of QC systems, procedures and facilities with applicable pharmaceutical standards, in particular the relevant national and international cGMP regulations.
• Ensure comprehensive planning for all activities and infrastructure to support QC lab operational readiness including documentation and electronic systems enabling production start of the mRNA clinical manufacturing facility.
• Transfer and implement all required global QC procedures including equipment qualification, method validation and all associated documentation to onsite QC labs and external labs as necessary.
• QC test procedures include methods for raw material testing, compendial test methods, product testing, environmental monitoring and microbiological test methods
• Implement effective and reliable sample management and raw material testing and release processes
• Support hiring, training, onboarding and qualification of local QC team
• Support knowledge transfer to the BioNTainer manufacturing site in collaboration with the global and local team.
• Develop and implement QC systems and procedures for the testing and release of mRNA-based vaccines in compliance with GMP regulations and standards.
• Partner with Analytical Development, Global QC and Analytical Science & Technology organizations to implement state-of-art testing strategies and ensure continuous improvement
• Ensure implementation of testing processes considering cost efficiencies, sustainability, quality, and safety to maintain GMP status
• Approve starting materials, packaging materials, bulk and finished products for Drug Substance and Drug Product.
• Ensure that all necessary testing is carried out and the associated records evaluated
• Approve specifications, sampling instructions, test methods and other QC procedures
• Oversee and manage contract test laboratories, including support of qualification activities.
• Ensure the qualification and maintenance of the QC laboratory, equipment, and systems and that appropriate validations are done
• Ensure that personnel are appropriately trained for their roles
• Lead investigations for OOSs in collaboration with subject matter experts
• Ensure that change control procedures are initiated and executed appropriately.
• Establish departmental goals, metrics and monitor initiatives and performance.
• Build, lead, motivate, and develop the team in accordance with company leadership principles.

QUALIFICATIONS

• University degree (MSc) in relevant scientific discipline (e.g., Biology, Chemistry, Pharmacy)
• +10 years relevant experience within the pharmaceutical industry in QC testing roles.
• Broad knowledge and practical experience of analytical sciences and technologies with prior experience in mRNA and/or nanoparticle-based formulations desirable.
• Prior experience supporting analytical method transfers and the QC testing and release of investigational medicinal products for clinical trials.
• Experience with local and international regulations and processes, particularly in the context of the manufacture, testing and release of investigational medicinal products for clinical trials.
• Experience in hosting and collaborating with national or international regulatory agencies.
• Strong understanding of pharmaceutical business and quality governance
• Experience building and leading teams and in establishing departmental goals and metrics, monitoring performance and enabling continuous improvement.
• Strong technical and people leadership skills including willingness to mentor team members and share knowledge.
• 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.
• 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.
• 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 on promises, goals, and expectations.

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