Exec Director, Drug Substance Development & Manufacturing

Essential Duties and Responsibilities

• Overall responsibility for drug substance (API) from preclinical and clinical development through process validation, site qualification, HA approval, commercial manufacturing oversight, including driving process improvements, manufacturing robustness and cost savings
• Leads and directs the Joint Management Team (JMT) in the Esperion CMO Management Structure with regular check-ins with the Joint Steering Committee (JSC)
• Prepare and align team thinking so that regulatory starting materials (RSM’s), intermediates and API are seamlessly integrated, project milestones achieved as planned and budgets managed accordingly
• Site identification, selection (with QA/QC and SC) and management of Contract Manufacturing Organizations (CDMOs/CMOs) for process optimization, cGMP manufacture and supply of API in support of ongoing clinical programs and commercial sales
• Deliver robust, scalable and cost-effective manufacturing routes and processes for pipeline and commercial products that are critical for successful Health Authority filings and with competitive cost of goods (COGS)
• Execute plans for the validation, site qualification and registration of API processes at all CMO’s as required by cGMP, ICH (International Conference of Harmonization) FDA/EMA and global Health Authority regulations
• 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 for process improvements, new chemical syntheses and formulations, and batch investigations and deviations
• Lead author, review, and approve technical reports/regulatory documents (INDs, IMPDs, and NDA/MAAs) for global submissions
• Lead and partner with legal, QA, and regulatory, including corresponding consultants, for ensuring compliance in the manufacturing of APIs under current GMP standards
• Prepare and manage the Drug Substance Development and Manufacturing department budget

Qualifications (Education & Experience)

• Bachelor’s of Science Degree, with PhD preferred, in a relevant scientific discipline with a minimum of 15 years of experience in the pharmaceutical industry specifically in clinical and/or pharmaceutical API development and/or manufacturing; or equivalent education and experience required
• 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