Company Overview
Our Mission: At Esperion, we are working tirelessly to deliver innovative medicines that help patients reach their goals today, tomorrow, and into the future.
Esperion is a fully remote based company with a corporate headquarters located in Ann Arbor, MI. The Company offers a competitive salary including a performance-based bonus program and stock-based compensation, a comprehensive benefits package including a 401(k) matching plan and health insurance, and paid time off and holidays.
Position Title: Executive Director, Drug Substance Development and Manufacturing
Preferred Location: Remote – US
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.
- Responsible for preparation and management of Drug Substance Development and Manufacturing department budget.
*additional duties and responsibilities as assigned
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