About this role
For one of our clients in the pharma industry, we are looking for a freelance Subject Matter Expert (SME) in Product Analytics & QC Method Transfer
Project Name: Product Analytics
Project description: The performance is requested as part of strategic initiatives to establish and optimize analytical control systems at the product level over the entire product life cycle. The overall goal of this project is to build a standardized, GMP-compliant analytical framework for novel modalities at external production sites (CMO/CLO). This initiative prepares the basis for robust method transfer and technical support for regulatory compliance across the global manufacturing network.
Tasks:
- Technical elaboration and architectural structuring of the analytical continuation of projects from development status to operations status and launch (instead of internal project management).
- Conceptual development of analytical strategy concepts and professional solution architectures for new projects and modalities (from clinical phase II to launch).
- This includes: Delivery of documented analytical transfer concepts, structured strategy documents and solution architectures for defined project phases.
- Technical evaluation of QC activities & method transfers
- Analytical evaluation of QC-related parameters in preparation for project delivery (internal and, if necessary, external).
- Technical elaboration of analytical method transfers, including the preparation of necessary authority and state lab requirements.
- This includes: Preparation and handover of planning and control concepts for the transfer as well as drafts for GMP-relevant documentation, approval documents and technical reports.
- Analytical evaluation of project deviations & information preparation
- Technical evaluation and analytical evaluation of documented technical issues and deviations resulting from the project status (instead of ad-hoc input on demand).
- Conceptual information preparation for interdisciplinary interfaces (Innovation Unit, local QC units, Development Operations, CMOs, CLOs and external partners).
- This includes: handing over formalized analytical opinions, technical risk assessments and structured technical information packages for product teams.
Results (deliverables) & objective of service provision: The aim of service provision is to develop analytical concepts at product level, to prepare method transfers in a regulatory and GMP-compliant manner and to provide a sound analytical basis for decision-making. Since an initial aggregated final report is not required for this project, the final formal handover takes place through the ongoing preparation and delivery of defined strategy documents, transfer concepts, GMP drafts and analytical statements. All documents are received by client for final review and approval before they are used further.
Required skills:
- Fluent German and English to process bilingual project documentation and interface globally.
- Extensive experience navigating GMP-compliant analytical frameworks and global quality control parameters.
- Willingness to work completely autonomously with restricted IT access, specifically analyzing provided analytical data and reports.
Must-Haves (Core Competencies)
- Subject matter expertise in the analytical frameworks for specific novel modalities: Peptides, ATCs (Advanced Therapy Medicinal Products), and IVT (In Vitro Transcription).
- Deep knowledge of global regulatory standards and state lab requirements specifically for the FDA (US), EMA (Europe), and JP (Japan/PMDA/MHLW).
- Proven track record executing analytical method transfers from Development (Clinical Phase II+) to external Operations/Launch (CMOs/CLOs).
- Demonstrated ability to independently evaluate technical project deviations from raw analytical data and reports to produce formal risk assessments.
Nice-to-Haves (Value-Add Differentiators):
- Specific experience aligning complex, cross-regional regulatory submissions (e.g., harmonizing FDA, EMA, and JP analytical requirements simultaneously).
- Prior independent consulting experience with the clients specific external manufacturing network or global CLO/CMO partners.
- Proven ability to deliver strategic concepts and GMP drafts without reliance on internal client project management.
Start: ASAP
Duration: till end of 2027
Location: remote
Capacity: 40h/week