We are seeking an experienced Analytical Subject Matter Expert (SME) and CMC Technical Writer to support external drug substance (DS) and drug product (DP) development programs within External Alternative CMC development (EACD) at Boehringer Ingelheim. The successful candidate will collaborate with internal cross-functional teams and external partners (CDMOs/CROs) to ensure scientifically robust analytical strategies and clear, compliant CMC documentation aligned with global regulatory expectations. - Provide scientific leadership in phase appropriate external DS/DP analytical development/QC for NCE and NCE-like (e.g., Oligonucleotide) entities, including method development, validation, transfer and lifecycle management.
Required Skills: - Significant working experience (>6 years) in pharmaceutical/biotech CMC and analytical development of NCE and NCE-like drug substance and solid and liquid formulations.
- BS degree in a scientific discipline with 5+ years' experience or MS with 3+ years of experience or a combination of experience and training .
- Provides supervision on the floor enforcing compliance data integrity, SOPs, specifications, methods, USP, and cGMP through real time verifications of records, logbook, chromatograms, sequences, etc.
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