Esperion
201 - 500 employees
Founded 2008
🧬 Biotechnology
⚕️ Healthcare Insurance
💊 Pharmaceuticals
Biotechnology • Healthcare Insurance • Pharmaceuticals
Esperion is a leading global biopharmaceutical company focused on developing innovative treatments for cardiovascular disease. Through commercial execution and international partnerships, it aims to provide broad access to its approved therapies. With a commitment to advancing its pre-clinical pipeline, Esperion is pioneering research in ACLY biology and developing next-generation inhibitors to address pressing health challenges.
Executive Director – Drug Substance Development & Manufacturing
🕒 March 26
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Esperion
201 - 500 employees
Founded 2008
🧬 Biotechnology
⚕️ Healthcare Insurance
💊 Pharmaceuticals
Biotechnology • Healthcare Insurance • Pharmaceuticals
Esperion is a leading global biopharmaceutical company focused on developing innovative treatments for cardiovascular disease. Through commercial execution and international partnerships, it aims to provide broad access to its approved therapies. With a commitment to advancing its pre-clinical pipeline, Esperion is pioneering research in ACLY biology and developing next-generation inhibitors to address pressing health challenges.
📋 Description
• 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
🎯 Requirements
• 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
🏖️ Benefits
• 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
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