Consultant (m/f/d) for Building a GMP-Compliant Framework

Project overview

The service is requested within the scope of strategic initiatives for the establishment and optimization of product-level analytical control systems throughout the entire product lifecycle. The overarching goal of this project is to build a standardized, GMP-compliant analytical framework for novel modalities at external manufacturing sites (CMO/CLO). This initiative lays the foundation for robust method transfer and technical support for regulatory compliance across the global manufacturing network.

Technical elaboration and architectural structuring of the analytical continuation of projects from the development status to the operations status and launch (instead of internal project management).

Technical Evaluation of QC Activities & Method Transfers

Analytical Evaluation of Project Deviations & Information Preparation

Results (Deliverables) & Goal of Service Provision:

The service provision aims to technically elaborate product-level analytical concepts, prepare method transfers in a regulatory and GMP-compliant manner, and provide sound analytical bases for decision-making. As an initial aggregated final report is not required for this undertaking, the final formal handover will occur through the ongoing creation and delivery of defined strategy documents, transfer concepts, GMP drafts, and analytical statements. All documents will be received for final review and approval by the client before further use.

Skills

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Expertise in analytical methods for specific novel modalities: Peptides, ATMPs (Advanced Therapy Medicinal Products), and IVT (In-vitro Transcription). Profound knowledge of global regulatory standards and the requirements of state laboratories, especially FDA (USA), EMA (Europe), and JP (Japan/PMDA/MHLW).

• Conceptual development of analytical strategy concepts and technical solution architectures for new projects and modalities (from Clinical Phase II to Launch).
• Analytical evaluation of QC-related parameters to prepare for project transfer (internal and, if applicable, external).
• Technical elaboration of analytical method transfers, including the creation of necessary authority and state lab requirements.
• Technical evaluation and analytical assessment of documented technical issues and deviations arising from the project status (instead of ad-hoc support on demand).
• Conceptual preparation of information for interdisciplinary interfaces (Innovation Unit, local QC units, Development Operations, CMOs, CLOs, and external partners).
• Fluent German and English skills for processing bilingual project documentation and for global communication.
• Comprehensive experience in handling GMP-compliant analytical methods and global quality control parameters. Willingness to work independently with limited IT access, particularly for analyzing provided analytical data and reports.
• Proven experience in transferring analytical methods from development (Clinical Phase II+) to external contract manufacturers/contract development and manufacturing organizations (CMOs/CLOs).
• Ability to independently assess technical project deviations based on raw data and reports to create formal risk assessments.
• Experience in coordinating complex, cross-regional marketing authorization applications (e.g., simultaneous harmonization of analytical requirements from FDA, EMA, and JP).
• Experience in independently consulting with Boehringer Ingelheim's external manufacturing network or global CLO/CMO partners.
• Proven ability to independently create strategic concepts and GMP drafts without support from the client's internal project management.

Project details

• Start: 01.12.2026
• Duration: 31.12.2027
• Location: 55218 Ingelheim, DE
• Languages: German