Eva Rosenberg

Technical (Cmc) Development Leader Biologics Eu @Roche

Munich, DE
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Jan 2022 — Present

Technical (Cmc) Development Leader Biologics Eu @Roche

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accountable for driving product development through regulatory approval for launch in the key markets, building the foundation for robust commercial supply+ Enable cross-functional collaboration and decision-making across key technical disciplines, ensuring alignment on development strategy, technology transfer readiness, and lifecycle considerations.+ Leadership of global technical development teams for several ocular drug-device combination assets in early stage and late stage+ Development and implementation of late stage CMC strategies to support fast path to market + Ensuring optimal information flow and transparency across the team, to key stakeholders, functional management, and governance committees+ Enabling decision-making and shaping alignment to adhere to project timeline and defined technical deliverables+ Responsible for project planning, scheduling, resourcing and reporting for CMC including risk and issue management+ Early stage global program due diligences for CMC+ Internalization of external portfolio for CMC+ CRO and CMO assessments for early and late stage assets including device

EDUCATION

2000 — 2005

Ludwig-Maximilians-Universität München

License as Pharmacist, Pharmacy

2006 — 2010

Ludwig-Maximilians Universität München / LMU Munich

Dr. rer. nat., Pharmaceutical Technology and Biopharmaceutics (Chair: Prof. Dr. G. Winter)

1988 — 1997

Immanuel Kant Gymnasium

Abitur

SKILLS

Protein ChemistryPharmaceutical IndustryMallsProject PlanningVirus Clearance ValidationPatent ApplicationsUltrafiltrationBiotechnologyProtein PurificationLifesciencesTffFiltrationBiochemistryHplcProject Management

ABOUT EVA ROSENBERG

Result driven, dynamic and open-minded leader in CMC Technical Development of Pharma Biologics. My mission is to empower people, to drive decisions in international cross-functional teams and to help teams to focus and to achieve excellent results to bring medicines to patients fast.I am excellent in communication and in crafting transparency and alignment across different technical functions to transform late stage IMPs in clinical development to a commercial product.Collaboration in a trusted and reliable relationship within teams is key for me to make impact and to embark to new standards.

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Eva Rosenberg — Technical (Cmc) Development Leader Biologics Eu at Roche in Munich, DE | Unifers