Associate Director Potency Assays - Method Lifecycle Management

Biopharma Asia; Mainz; Hybrid; EUR 120,000 - 160,000; Full time

Job summary

Biopharma Asia in Mainz, Germany is seeking an Associate Director for Potency Assays – Method Lifecycle Management. You will provide analytical expertise for potency assays across a global network, ensuring lifecycle management and GMP compliance for late-stage and commercial projects.

You will lead method validation, transfer strategies, and lifecycle activities, collaborate with CMC and external partners, and review technical/regulatory submissions to support regulatory approvals and market

Qualifications

• University degree in scientific/life-science-related field (PhD desirable).
• Minimum of 5+ years of experience in QC (ideally analytical development) within the pharmaceutical industry.
• Strong analytical expertise in potency assays, including substantial hands-on experience with cell-based assays (CBA).
• Experience with GMP-compliant analytical methods, including method validation, transfer, and lifecycle management.
• Strong stakeholder management, communication, and cross-functional collaboration skills.
• Fluency in English; German language skills are desirable.

Responsibilities

• Provide analytical expertise for potency assays supporting late-stage and commercial projects across a global network.
• Design and performance of method validation and transfer strategies, plus lifecycle management activities.
• Participate in strategic and technical project discussions with CMC and external partners.
• Evaluate and review technical and regulatory submission documents to support approvals and market launch of development products.
• Act as an analytical SME, supporting regulatory filings and responding to regulatory queries.

Skills

Potency assays expertise

Cell-based assays (CBA)

GMP analytical methods

Stakeholder management

Cross-cultural collaboration

English fluency

German language desirable

Education

University degree in scientific/life-science field

PhD desirable

Job description

Mainz, Germany | full time | Job ID:11880

About the Role:

As Associate Director Potency Assays – Method Lifecycle Management, you will provide analytical expertise for potency assays supporting late-stage and commercial projects across a global network. You will help ensure that methods are effectively managed throughout their lifecycle and comply with applicable GMP requirements.

Your Contribution:

• Provide technical and analytical expertise in the field of potency assays for late-stage and commercial projects across a global network
• Be responsible for the design and performance of method validation and transfer strategies, as well as method lifecycle activities, including the exchange of critical reagents, method performance assessments, and laboratory investigations
• Participate in strategic and technical project discussions, working cross-functionally with CMC team members and external partners
• Evaluate and review technical and regulatory submission documents in a timely manner to support the approval and market launch of development products
• Act as an analytical SME, providing expert knowledge for regulatory filings and contributing expertise to health authority questions and responses to regulatory submissions

A good match:

• University degree in a scientific/life-science-related field, PhD desirable
• Minimum of 5+ years of experience in QC (ideally analytical development) within the pharmaceutical industry
• Strong analytical expertise in potency assays, including substantial hands-on experience with cell-based assays (CBA)
• Experience with GMP-compliant analytical methods, including method validation, transfer, and lifecycle management
• Strong stakeholder management, communication, and cross-functional collaboration skills
• Strong intercultural communication skills and the flexibility to collaborate across time zones and global sites
• Fluency in English, both written and spoken, German language skills are desirable

Your Benefits:

It's our priority to support you:

Your flexibility: flexible hours |vacation account

Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning

Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential

Your health and lifestyle: Company bike

Your mobility: Job ticket | Deutschlandticket

Your life phases: Employer-funded pension | Childcare

Job ID 11880(please always specify if you have any questions)

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.

Note for applications within Europe: Please note that if you wish to claim travel expenses incurred in connection with an in-person interview, we are obliged to carry out a sanctions list check*. This is carried out by our partner, HireRight. Travel expenses will only be reimbursed if this sanctions list check does not yield any matches. Reimbursement can be made provided that the check is successfully completed.

* Your first name, surname and date of birth will be processed for the sanctions list check. The legal basis for carrying out the sanctions list check for positions at BioNTech in Europe is BioNTech’s legitimate interest. Please note that BioNTech will not carry out the sanctions list check if no travel expenses are to be reimbursed. If you do not give BioNTech your consent to the sanctions list check, your travel expenses cannot be reimbursed. This will not affect your application.