Senior Manager* QC (Microbiological methods)

Become a member of the BioNTech Family!

Who we are:
We are a global immunotherapy company. Our 5,000+ colleagues globally are committed to improving the health of people worldwide with our fundamental research utilizing the full potential of the immune system to fight cancer, infectious diseases and other serious diseases. We leveraged our mRNA technology to develop a COVID-19 vaccine which became the first mRNA drug approved for human use.
 
What we do with the BioNTainers:
We want to improve healthcare by making our innovations accessible worldwide. Therefore, we developed the first modular mRNA-manufacturing facilities based on a container solution called “BioNTainers”.  The aim is to build a regional manufacturing network in Africa, with Africa, for Africa.
 
Why we need you:
The BioNTainers will be equipped to produce a range of mRNA-based vaccines targeted towards the needs of African Union member states. You will become part of the regional staffing team, driving the establishment of the regional African end-to-end mRNA manufacturing network.

Senior Manager* QC (Microbiological methods) 

As Senior Manager* QC, Microbiological methods, you will be planning, coordination and overseeing of all activities of the Microbiology Unit, as well as implementing Systems and required tests methods. While working closely with the team, you will Ensure Compliance with GMP and Regulatory requirements.

Your main responsibilities are:

• Define (URS) and order the required instruments for the microbiology laboratory. (In compliance with company requirements).
• Issue and update all related SOPs & test methods according to the Guidelines.
• Share in the validation and execution of the instrument qualification and validation.
• Set the schedule and supervise the preventive maintenance and calibrations. (According to the valid contracts).
• Defining and order the Reference materials, chemicals & miscellaneous requirements for the laboratory.
• Establish and implement the Environmental and personnel monitoring system with issuing of reports.
• Define the required structure of the microbiology team.
• Cleanrooms monitoring and validation.
• External testing planning and implementation (if required).
• Responsible for receipt of raw material, Drug substance and drug product from the production blocks, making entries in the sample receipt records and planning of sample analysis accordingly.
• To review the documents related to Raw materials, Drug substance and Drug Product release i.e. sterility test, bacterial endotoxin test, microbial limit test
• Responsible for reviewing the records of in process release of products i.e. bioburden analysis, antibiotic assay, biological indicators … etc.
• To establish and monitor the sample management system and planning of testing of raw material, Drug substance and Drug product.
• Responsible for ensuring the testing and releasing of raw material, Drug substance and Drug Product from microbiology laboratory as per defined procedure and reviewing the results.
• Responsible for preparation of validation/qualification protocol, execution of validation activities and review of report of microbiological methods.
• Managing deviation, change control, incidences with investigation and associated CAPA.
• Investigation of OOS in the laboratory and associated CAPA with cooperation with the QA department.
• Responsible for preparation of standard operating procedures, validation protocols and execution.
• Responsible for the participation in media fill activity as planning.
• Responsible for planning and qualification of microbiologist for various testing done in microbiology laboratory.
• To impart trainings to the subordinates as per requirement in the company.
• To participate in training programs organized by the company.
• To ensure the cGMP norms are followed while performing analysis.
• To maintain the inventories of the lab as per requirement.
• Ensure that all concepts of data integrity are fully respected and followed in the laboratory.

what you have to offer:

• Bachelor’s degree of pharmacy.
• Experience in management of Microbiology laboratory at least 7 years. (Working in sterile manufacturing is a must).
• Experience in Microbiological Validation of Utilities and clean rooms.
• High experience in Environmental monitoring and clean utilities.
• Good Management of teams.
• Good Knowledge of Microsoft Excel.
• Good English communication.
• Background on SAP Environment.
   

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