{"id":6,"date":"2023-03-29T08:12:00","date_gmt":"2023-03-29T08:12:00","guid":{"rendered":"http:\/\/cgrube.com\/?page_id=6"},"modified":"2026-03-17T16:36:22","modified_gmt":"2026-03-17T16:36:22","slug":"cgrube-consult","status":"publish","type":"page","link":"http:\/\/cgrube.com\/index.php\/cgrube-consult\/","title":{"rendered":"Background"},"content":{"rendered":"\n
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Education and Certifications<\/strong><\/p>\n\n\n\n

MSc BA<\/strong> \u2013 Business Administration and Bioentrepreneurship<\/p>\n\n\n\n

PhD<\/strong> \u2013 Organic and Medicinal Chemistry<\/p>\n\n\n\n

MSc<\/strong> \u2013 Chemical Engineering (Organic Chemistry)<\/p>\n\n\n\n

Diplom-Ingeni\u00f8r<\/strong> \u2013 Organic Synthesis<\/p>\n\n\n\n

Certified Project Manager<\/strong>
(Expert PM (Implement), PRINCE2, PMBOK-based methodologies)<\/p>\n\n\n\n

Certified ScrumMaster<\/strong> (SAFe)<\/p>\n\n\n\n

Regulatory and GMP Training<\/strong>
ICH, FDA, and GMP frameworks<\/p>\n<\/div>\n\n\n\n

\n

Experience<\/strong><\/p>\n\n\n\n

CMC and Operational Management<\/strong><\/summary>\n

15+ years working with small molecules, bioconjugates, linkers, mAbs and regulated development environments across R&D, CMC, clinical, and commercial stages.<\/p>\n\n\n\n

Delivered full CMC packages (IND\/IMPD) for Phase 1 ADC programs, including QMS, manufacturing and regulatory support.<\/p>\n\n\n\n

Cross-Functional and External Collaboration<\/strong><\/summary>\n

Extensive 12+ years of experience working with external partners, CROs, CDMOs, and CMOs across Europe, US, and Asia.<\/p>\n\n\n\n

Facilitated project and CDMO alignment between QA, QC, RA, Clinical Supply, and Non-Clinical teams throughout early, late and commercial phases in Biotech and Pharma.<\/p>\n\n\n\n

Led innovation and cost-optimization initiatives, improving documentation flows and exceeding KPI targets in Novo Nordisk and Ascendis Pharma.<\/p>\n\n\n\n

Additional Achievements<\/strong><\/summary>\n

Managed >10M USD program budgets (ADC) and negotiated significant cost reductions using data-driven approaches.<\/p>\n\n\n\n

Due diligence<\/p>\n\n\n\n

IP strategies<\/p>\n<\/details>\n<\/details>\n<\/details>\n\n\n\n

Quality Management and Governance Systems<\/strong><\/summary>\n

Led CMC strategy and execution for oncology ADC Ph1 programs at Adcendo, managing mAb, linker-payload, DS, DP flows.<\/p>\n\n\n\n

Established commercial production, LCM activities and introduced process verification settings at Ascendis Pharma.<\/p>\n<\/details>\n\n\n\n

Regulatory Compliance Leadership (INDs\/MAAs, NDA\/MAA\/CN, BLA\/MAA\/CN) <\/strong><\/summary>\n

Supported regulatory CMC submissions thereof Ph3\/IND\/IMPD and NDA\/MAA\/CN for oral excipient used for commercial product on market and BLA\/MAA\/CN for linker used for bioconjugate product on market. Also authored\/reviewed full CMC IND\/IMPD modules 2.3\/3 for ADC Ph1 (mAb\/LP\/ADC DS\/ ADC DP) and another ADC Ph1 (LP) and Ph2 (DS peptide intermediate).<\/p>\n\n\n\n

Managed cross-functional governance and decision support for global filings of Module 2.3 and 3.<\/p>\n\n\n\n

Strong on LP and DS writing, control strategies, API SM strategies, characterisation and robust process evaluations.<\/p>\n<\/details>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

Education and Certifications MSc BA \u2013 Business Administration and Bioentrepreneurship PhD \u2013 Organic and Medicinal Chemistry MSc \u2013 Chemical Engineering (Organic Chemistry) Diplom-Ingeni\u00f8r \u2013 Organic Synthesis Certified Project Manager(Expert PM (Implement), PRINCE2, PMBOK-based methodologies) Certified ScrumMaster (SAFe) Regulatory and GMP TrainingICH, FDA, and GMP frameworks Experience<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-6","page","type-page","status-publish","hentry"],"yoast_head":"\nBackground - Cgrube Consult<\/title>\n<meta name=\"description\" content=\"Expert Project Manager, ScrumMaster and PhD in Chemistry besides Masters in Engineering, Business Administration and BioEntrepreneruship\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"http:\/\/cgrube.com\/index.php\/cgrube-consult\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Background - 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