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Senior Manager* Validation, MS&T

As Validation Senior Manager*/MS&T you act as the SPOC for all site related process validation activities in MS&T, ensuring manufacturing and cleaning processes are validated where state of validation at site is maintained. You are also responsible in leading the site technology transfer activities and work with cross functional teams on technology, processes, and knowledge. Support MS&T activities in ensuring site GMP readiness.

You directly support production in one or several production steps for all process specific issues in order to ensure on-time completion of processes, continuous quality and productivity improvements, and compliance with cGMP regulations, SOPs, guidelines, and functional standards (e.g. SHE)

Your main responsibilities are:

• Overall responsibility for establishment, prioritizations, execution and tracking of Validation Master Plan for process, hold time study, cleaning, packaging validation and ongoing process verification (OPV)
• Define and setup pre-validation / validation strategy. Align with experts, manufacturing, quality, QC and AS&T on the manufacturing handling, stability, comparability strategy, and ensuring regulatory compliance; close collaboration with global process lead to ensure local process application
• Actively managing MS&T activities in ensuring site GMP readiness which includes contributing to cross contamination strategy, ensuring MS&T documentation/procedures are in line with the latest guideline with health authority and industry standards.
• Assess impact of technical changes, assess their technical feasibility, and determine scope / design of technical batches, challenge technical risk and business benefit of technical changes proposed.
• Support technology transfer of new products, defining manufacturing processes, establishing process control strategy, and developing process validation strategies.
• Act as subject matter expert (SME) for product and process knowledge, has extensive subject matter expertise for product and process trends by supporting the APQR process when analyzing and promoting technological process innovations and when implementing process control strategies
  • Provide technical expertise and facilitate establishment of Quality Risk Assessment includes but not limited to facility fit assessment, control strategy, material/extractable and leachable assessment, process assessment etc.
  • Provide scientific/technical expertise during the project startup phase and as well as during the routine manufacturing; Act as subject matter expert (SME) for product and process knowledge, has extensive subject matter expertise for product and process trends by supporting the APQR process when analyzing and promoting technological process innovations and when implementing process control strategies
• Directly supports production by collaborating with shift teams to ensure that all batches are produced safely, on time, and in compliance with manufacturing specifications and quality requirements
• Responsible as author or reviewer of MS&T documentation such as validation plan, master batch record, protocol, and protocol report on the timely manner and accurate; Prepare and maintain master production documentation for the assigned products, including masterbatch records (MBRs), material parts lists, recipes, risk assessments (QRAs), Zurich risk analysis, and ensures that production SOPs are updated and/or prepared
• Ensures that all critical parameters are within written regulations (e.g. masterbatch record, risk assessment, validation batch record)
• Lead and drive root cause investigation of process failures, initiate and lead product improvement projects, involving cross-functional team.
• Contribute to all relevant audit inspection and ensure inspection readiness for all technical transfer-related aspects for the site. Ensure compliance with relevant regulatory requirement, GMP, and other industry standards throughout the transfer process.
• Contribute to process improvement and optimization for product transfers.
• Prepare and maintain master production documentation for the assigned products, including masterbatch records (MBRs), material parts lists, recipes, risk assessments (QRAs), Zurich risk analysis, and ensures that production SOPs are updated and/or prepared

What you have to offer:

• BSc. in Pharmacy, Pharmaceutical Technology, Biochemistry, Chemistry, or equivalent scientific / engineering degree. Desirable MSc. or equivalent experience.
• At least 10 years of working experience in MS&T/production in pharmaceutical or biotechnology industry
• Extensive experience in the (aseptic) production of vaccines under GMP conditions. Have experience in process development/ tech transfer activities/process validation.
• Knowledge of the current regulatory requirement and good understanding for guidance document for instance FDA/ICH/EMEA/cGMP
• Hands on experience in project management, supporting technical transfer, GMP expertise and good understanding of working in GMP environment.
• Excellent communication skills and ability to effectively collaborate in dynamic, cross functional matrix 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!

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