Process Specialist*

Join our team of pioneers!!

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.

Process Specialist* 

The Process Specialist is the technical expert responsible for providing technical support during the manufacturing and production of pharmaceutical products (vaccines). MS&T Process Specialist provides technical support for cGMP activities such as tech transfer, process engineering, process validation, process monitoring, and computer system validation (CSV) in the cGMP manufacturing facility. The role is to ensure the scientific and technical integrity of the data generated during the manufacturing process and product throughout the lifecycle.

The Process Specialist is responsible for maintain data for the organizations while also protecting the data assets. The incumbent will support all operational aspects of MS&T department includes, technology transfer, process monitoring/support, change control and deviation closure.

Your main responsibilities are

• Subject Matter Expert for pharmaceutical manufacturing process technologies including any pilot scale, scale up or down, and Design of Experiments (DoE).
• Provides primary (on floor) production support. Identifies and implements process improvements related to safety, environmental, quality, compliance, productivity, yield, and cost.
• Provides technical support for the investigation and resolution of deviations and atypical events by partnering with Quality Assurance to ensure consistent quality standards are maintained
• Assure regulatory compliance and technical feasibility of proposed changes. Conduct risk assessment and develop mitigation strategies to address potential technical, operational, regulatory challenges during the transfer process and commercial production.
• Recommends and implements corrective/preventative measures aimed at improving compliance and reducing repeat occurrences. Follow up to determine if corrective actions adequately addressed root cause of NC event.
• Lead and participate in the definition, selection, and gap assessment of process-specific pharmaceutical equipment and systems. Provide technical expertise for equipment qualification around technologies.
• Collaborate with technical development, other sites, and global MS&T network to facilitate transfer of technical knowledge to local.
• Develop, review and approve guideline documents, Standard Operating Procedure, technical protocols, and reports.
• Demonstrates expertise in the following areas: cGMPs, FDA regulations, mRNA manufacturing processes, manufacturing equipment and utilities.
• 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.
• Excellent documentation of activities in accordance with GMP regulations

What you have to offer

• Bachelors/Masters degree in natural /life sciences or engineering sciences including Pharmacy, Pharmaceutical Technology, Biochemistry, Biotechnology, Chemistry, or equivalent scientific / engineering degree or comparable training
• Proven experience in a technical role such as manufacturing, quality control or regulatory affairs in pharmaceuticals, food and beverage industries.
• A good understanding of working in GMP environment is an added advantage.
• Proficiency in data analysis and interpretation to drive informed decision.
• Solution-oriented & service-orientated way of working
• Very good planning and organizational skills
• Self-motivated work attitude and an ownership spirit for the job
• Ability to adapt to changing priorities effectively and work in a start-up environment.
• Strong communication skills and ability to effectively collaborate in dynamic, cross functional matrix.

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