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.
Since starting 18 months ago, we’ve raised $100,000,0000+ from world-class investors such as Lightspeed Venture Partners, Khosla Ventures, Contrary Ventures and Google Ventures, as well as more than 20 angel investors who’ve built, scaled, and exited some of the most impactful companies of the last decade. Build accounting workflows and support customers and the customer success team with with hands on guidance and training - we believe the best documentation comes from firsthand experience with the platform and real world customer experience. |