Senior Analytical Development & QC Technology Transfer Consultant (Pharma / GMP)

Project overview

Project focus: Development and elaboration of analytical strategies and GMP-compliant control concepts for innovative pharmaceutical active ingredients and therapeutic forms from clinical development (Phase II) to commercial market launch. Focus on CMC Analytics, Analytical Development, QC Method Transfer as well as Peptides, ATMPs and IVT.

Requirements

Nice-to-haves

Important information:

• Many years of professional experience in pharmaceutical analytics, especially Analytical Development, Quality Control or CMC Analytics
• Sound GMP knowledge and experience with international regulatory requirements
• Demonstrable experience with analytical method transfers from clinical development to commercial production
• Profound expertise in novel modalities, especially peptides, ATMPs (Advanced Therapy Medicinal Products) and IVT (In Vitro Transcription)
• Experience in the development of GMP-compliant analytical control strategies and QC concepts
• Knowledge of regulatory requirements from FDA (USA), EMA (Europe) and PMDA/MHLW (Japan)
• Experience in the independent creation of GMP-relevant documentation, analytical strategies and transfer concepts
• Experience in the evaluation of analytical data as well as in the assessment of technical deviations and quality-related issues
• Experience in the creation of technical risk analyses and regulatory documentation
• Independent, strategic and conceptual way of working
• Experience as an independent consultant in the pharmaceutical CMC/QC environment
• Project experience at Boehringer Ingelheim or comparable global pharmaceutical companies
• Experience in collaboration with external manufacturers and laboratory partners (CMO/CLO)
• Experience with international approval processes and the harmonization of regulatory requirements
• Experience in technical coordination with international interfaces and QC units
• Fluent German and English language skills

Project details

01.12.2026

13 months

Utilization: 4-5 days per week (37.5 hours)

Remote share: 100 %

OCR contact:

Patrik Androsevic

*@*.de

• Start: 2026-12
• Duration: 13 Monate
• Remote: remote
• Location: ingelheim, Deutschland, DE
• Languages: German