Senior Manager* QC (Raw materials & compendial 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 (Raw materials & compendial methods) 

As Senior Manager QC Raw Materials and Compendial Methods, you will be responsible of planning, coordination and overseeing all activities of the Raw Materials Unit as well as implementating systems and required tests methods. While working with  closely with the team in Rwanda, you will ensure Compliance with GMP and Regulatory requirements.

Your responsibilities are:

• Define (URS) and order the required instruments for the Raw materials Unit. (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 monitoring system with issuing of reports.
• Define the required structure of the Raw materials team.
• Cleanrooms monitoring and validation.
• External testing planning and implementation (if required).
• Responsible for receipt of raw material, making entries in the sample receipt records and planning of sample analysis accordingly.
• To review the documents related to Raw materials.
• Responsible for reviewing the records of raw materials testing.
• To establish and monitor the sample management system and planning of testing of raw material.
• Responsible for preparation of validation/qualification protocol, execution of validation activities and review of report of Raw materials test 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.
• Ensure and inspect all SHE related topic within the Raw material unit is complying.

What you have to offer:

• Bachelor’s degree of pharmacy.
• Experience in management of Raw materials testing at least 7 years. (Working in sterile manufacturing is a must).
• Experience in Validation of Utilities and clean rooms.
• High experience in Environmental monitoring and clean utilities. 
• Practical Experience with rapid identification methods (e.g.RAMAN) including library building and validation.
• Good Management of teams.
• Good Knowledge of Microsoft Office.
• Good English communication.
• Background on SAPERP and LIMS systems 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