Job Description

Open for hire at one of the following locations - Singapore. - Job ID: 6313

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.

Specialist* QC

The QC specialist supports the implementation of new analytical methods, qualification of new laboratory equipment, and/or supports the quality control aspects of clean zone qualification and production process qualification (e.g EM/water/gases sampling and testing or PPQ sampling and testing).

Your main responsibilities are:

• Execute sampling and testing to supports the analytical methods transfer requirements or quality control requirement for incoming raw materials, drug substances and drug production.
• Review qualification documents from global C&Q and local project team. Coordinate the execution of lab equipment qualifications as Lab equipment SME.
• Establish lab equipment procedures and provide trainings to new staff.
• Establish lab equipment maintenance plan and coordinate internal or external troubleshooting.
• Leads investigations for OOSs or deviations in collaboration with subject matter experts. Identifies and analyse the root cause of non-conformance reports and initiates CAPAs (Corrective and Preventive Actions)
• Reviews relevance of pharmacopoeia revisions for the work area (e.g. specifications, test methods).
• Executes and coordinates change control procedures
• Maintain the lifecycle of quality control department documentation (e.g. SOPs, forms, logbook or datasheet)
• Performs all assigned activities while observing all internal and regulatory requirements (safety and quality)
• Participates in internal self inspection and external health authority audits

What you have to offer.

• Completed bachelor degree in chemistry, biochemistry or chemical engineering or other relevant sciences
• At least 3 years of industry experience in QC/ Analytics in pharmaceutical industry/ GMP environment preferred
• Specific knowledge/ areas of expertise in one or more of these fields:

• chromatographic methods, in particular HPLC
• molecular biology (preferably e.g. RT-PCR, ddPCR, Dot-Blot, ideally experience working with RNA)
• electrophoretic methods
• spectrophotometric methods (e.g. UV-/VIS, Fluorescens, Endotoxin)
• physico-/ chemical methods including compendial methods (e.g. USP, Ph. Eur.), e.g. Dynamic light scattering, pH, osmolality, subvisible particles
• incoming goods testing/ raw material testing, sampling for incoming goods testing
• microbiology and/ or cell based assay
• Fluent written and verbal English
• High degree of conscientiousness and diligence (documentation, order and cleanliness at the workstation)
• Sense of ownership and honesty (proactive handling of errors)
• Constructive, solution-oriented work habits, flexibility
• Self-starter and pronounced willingness to learn
• Physical stamina

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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