Executive Director – Drug Substance Development & Manufacturing

🕒 vor 2 Monaten

🚗 Michigan – Remote

🚗 Michigan – Remote

💵 €320.500 - €365.000 / Jahr

⏰ Vollzeit

🔴 Experte

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Esperion

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201 - 500 Mitarbeiter

Gegründet 2008

🧬 Biotechnologie

⚕️ Krankenversicherung

💊 Pharmazie

Biotechnology • Healthcare Insurance • Pharmaceuticals

Esperion ist ein führendes globales biopharmazeutisches Unternehmen, das sich auf die Entwicklung innovativer Behandlungen für Herz-Kreislauf-Erkrankungen konzentriert. Durch kommerzielle Umsetzung und internationale Partnerschaften strebt es an, einen breiten Zugang zu seinen zugelassenen Therapien zu ermöglichen. Mit dem Engagement, seine präklinische Pipeline voranzutreiben, ist Esperion Vorreiter in der Forschung zur ACLY-Biologie und entwickelt Next-Generation-Inhibitoren, um dringende gesundheitliche Herausforderungen zu bewältigen.

Beschreibung

• Overall responsibility for drug substance (API) from preclinical and clinical development through process validation, site qualification, HA approval, commercial manufacturing oversight • Driving process improvements, manufacturing robustness and cost savings • Prepare and align team thinking so that regulatory starting materials (RSM’s), intermediates and API are seamlessly integrated • Site identification, selection (with QA/QC and SC) and management of Contract Manufacturing Organizations (CDMOs/CMOs) • Deliver robust, scalable and cost-effective manufacturing routes and processes for pipeline and commercial products • Execute plans for the validation, site qualification and registration of API processes at all CMO’s as required by cGMP, ICH FDA/EMA • Lead capacity expansions and technology transfers of APIs from one supplier to new suppliers on a global basis • Plan resources and develop mid to long term strategies for technical support to CMOs • Lead author, review, and approve technical reports/regulatory documents for global submissions • Responsible for preparation and management of Drug Substance Development and Manufacturing department budget

🎯 Anforderungen

• Bachelor’s of Science Degree, with PhD preferred, in a relevant scientific discipline • Minimum of 15 years of experience in the pharmaceutical industry specifically in clinical and/or pharmaceutical API development and/or manufacturing • Minimum of 8 years of direct line management experience • Experience in pharmaceutical development and manufacturing with a deep understanding of the drug development process • Technical and scientific knowledge to direct manufacturing oversight for clinical and commercial supply activities • Expert knowledge in US and EU ICH/GCP, SOPs and local regulatory requirements • Effective oral, written communication and presentation skills • Team oriented style, with an ability to build collaboration and engagement among both internal and external stakeholders • Strong leadership skills including the ability to develop and communicate a clear strategic vision, motivate team members, and proven success in creating high performing teams

🏖️ Vorteile

• Competitive salary including a performance-based bonus program and stock-based compensation • Comprehensive benefits package including a 401(k) matching plan and health insurance • Paid time off and holidays