Specialist QC (AS&T)

Singapore   |   full time   |   Job ID: 9222 

The Specialist QC (Analytical Science and Technology, AS&T - Contract role subject to renewal) is responsible for maintaining the method lifecycle of the test methods as used within Quality Control laboratory for drug substance (DS) and drug product (DP) analytical testing. This includes supporting the activities relevant to analytical methods validation/verification/transfer, methods troubleshooting, evaluate pharmacopoeia updates and critical materials/ reagents management to support the batch release of DS and DP. The role also provides analytical and coordination support for assigned projects in a cGMP–compliant and efficient manner. The Specialist QC (AS&T) support goals for quality, safety, health, and environment (SHE) compliance for the site. 

Your main responsibilities are:

• Evaluate new analytical methods transfer requirements or test method for drug substances and drug production.
• Coordinate on acquisition and qualification of new equipment / material / reagent as identified during new analytical method readiness.
• Participate in new method transfer meetings and key AS&T network meetings to support global AS&T initiatives and implementation.
• Maintain the availability and validity of critical reagents, reference materials / standard. Coordinate and perform material qualification process for new critical material or replacement lots.
• Maintain control samples trending for SGP QC.
• Evaluate any observable trends within implemented analytical methods and provide corrective action where necessary.
• Coordinate with cross functional team (example SCM, MFG and MS&T) to support on investigation or studies.
• Supports the quality control aspects of manufacturing process qualification (example PPQ and cleaning validation).
• Provide analytical method trainings to new staff.
• Lead 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.
• Assist the Senior Manager QC to establish / maintain operating and capital budgets. Ensure the team operates in a cost effective and efficient manner. Maintains an innovative approach based on productivity improvement, implementation of best practices and harmonization with technical operations.
• Comply and cooperate with site SHE requirements such as use of PPE usage, incident reporting and other requirements securing the safety, health and welfare while at work.

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 (capillary electrophoresis or equivalent), 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).
• Experience in method lifecycle management, analytical method transfer / validation / troubleshooting in a pharmaceutical industry / GMP environment preferred.
• Sense of ownership and honesty (proactive handling of errors)
• Constructive, solution-oriented work habits, flexibility
• Self-starter and pronounced willingness to learn

Your Benefits:

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.

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.