Job Description

Open for hire at one of the following locations - Singapore. - Job ID: 6311

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.

Techical Steward* MS&T

As a technical steward, you play a crucial role to setup BioNTech first mRNA manufacturing plant in Singapore. Technical Steward is responsible for overseeing the technical aspects of the processes, products, and technologies. The role is to ensure the scientific and technical integrity of the product throughout the lifecycle. The incumbent will support all operational aspects of MS&T department including technology transfer, process monitoring/support, change control and deviation closure. Your main responsibilities are:

• Lead and participate in the definition, selection, and gap assessment of process-specific pharmaceutical equipment. Current technology for production is end to end mRNA vaccine manufacturing.
• Conduct risk assessments and develop mitigation strategies to address potential technical, operational, regulatory challenges during the transfer process and commercial production.
• Lead and/or contribute to technology transfer to support the site readiness activities or new product launch such as but not limited to water run, process performance qualification activities
• Collaborate with technical development, other sites, and global MS&T network to facilitate transfer of technical knowledge to local.
• Stay current with the latest advancements in different technologies and manufacturing practices and implement relevant innovations to enhance facility capabilities.
• Author and review guideline documents, standard operating procedure, technical protocols, and reports. Write process related change controls, deviations and manage the implementation of defined CAPAs.
• Lead investigations and resolve technical issues with cross functional team and implement corrective and preventive actions. Set up studies to evaluate product characteristics.
• Be the technical process expert and support the operation team to ensure that all batches are produced safely, on time, and in compliance with manufacturing specifications and quality requirements.
• Subject Matter Expert for pharmaceutical manufacturing process technologies including any pilot scale, scale up or down, and Design of Experiments (DoE).
• Initiate, drive, and implement continuous improvement initiatives to optimize processes, enhance produce performance and drive operational excellence for better quality, safety, and efficiency.
• Contribute to all relevant audit inspections and ensure inspection readiness for the site. Ensure compliance with relevant regulatory requirement, GMP, and other industry standards.

What you have to offer.

• MSc/BSc. in Pharmacy, Pharmaceutical Technology, Biotechnology, Biochemistry, Chemistry, or equivalent scientific / engineering degree.

• Proven relevant experience in technical role within the bio/pharmaceutical in manufacturing, process development or MS&T
• Strong background in vaccines process development/manufacturing/fill and finish would be an advantage.
• Hands on experience in project management, supporting technical transfer, GMP expertise and good understanding of working in GMP environment.
• Proficiency in data analysis and interpretation to drive informed decision.
• Ability to adapt to changing priorities effectively and work at the start-up environment.
• Effective communication skills and ability to effectively collaborate in dynamic, cross functional matrix environment.
• Strong problem-solving skills and preferably with good proven knowledge in lean sigma methodology

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.
• BioNTech will run a background check during the hiring process

We are looking forward receiving your application.

*BioNTech does not differentiate on the basis of 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!

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