Required skills
Languages: German
Job description
Seeking a freelance Senior Scientist with expertise in analytical development, GMP, and method transfer for a 12-month, 100% remote project in the pharmaceutical industry, starting December 2026.
Responsibilities
Development and structuring of analytical strategies for novel modalities from clinical development (from Phase II onwards) to launch
Technical conception of the analytical transfer from Development to Operations
Evaluation of QC-relevant parameters and analytical control systems
Planning and technical elaboration of international analytical method transfers to external manufacturing partners (CMO/CLO)
Creation and evaluation of GMP-relevant documentation, transfer concepts, and regulatory documents
Independent analysis of technical issues and project deviations based on analytical data and reports
Preparation of well-founded technical statements and risk assessments
Consideration of international regulatory requirements and state-of-the-art specifications
Requirements
Several years of experience in Analytical Development, Analytical Science, QC, or CMC in the pharmaceutical or biopharmaceutical industry
In-depth expertise in analytical strategies for novel modalities, in particular:
Peptides
ATMPs (Advanced Therapy Medicinal Products)
IVT (In-vitro Transcription)
Comprehensive knowledge of international regulatory requirements, especially FDA, EMA, and Japanese authorities (PMDA/MHLW)
Demonstrable experience with analytical method transfers from clinical development into external manufacturing structures
Very good knowledge of GMP-compliant analytical control systems and global QC requirements
Experience in the independent evaluation of analytical data, technical deviations, and regulatory risks
Very good German and English language skills
Framework conditions:
Project details
December 2026
12 months
100 %
100 % remote
Languages: German and English (fluent)
For a demanding, strategic project in the pharmaceutical environment, we are looking for an experienced Senior Scientist (Freelance) with in-depth expertise in analytical development, GMP-compliant control systems, and international method transfers.
The focus is on establishing and further developing a standardized analytical framework for novel therapeutic modalities. The goal is to design analytical strategies across the entire product lifecycle and to prepare the transfer from Development to external commercial manufacturing from a technical and regulatory perspective.
12 months (December 2026 to December 2027)
Full-time project (100 %)
Independent, consulting service provision
Interested?
Then I look forward to hearing from you with a current CV and brief information on your availability and relevant project experience.
You are also welcome to send me a recommendation from your network.
#Freelance #SeniorScientist #AnalyticalDevelopment #AnalyticalScience #MethodTransfer #CMC #GMP #Pharma #Biopharma #ATMP #QualityControl
- Start: 2026-12
- Duration: 12 Monate
- Remote: remote
- Location: Frankfurt, Deutschland, DE
- Languages: German
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