Exec Director, Drug Substance Development & Manufacturing

Exec Director, Drug Substance Development & Manufacturing Ann Arbor, MI Job Details Full-time $320,500 - $365,000 a year 1 day ago Benefits Paid holidays Health insurance Paid time off 401(k) matching Qualifications FDA submissions Manufacturing management Strategic management Clinical development Bachelor of Science GMP Technical report writing 8 years Team development ICH guidelines Bachelor's degree Continuous improvement Doctor of Philosophy Good Clinical Practice Regulatory submissions Senior level Leadership Implementing cost-saving initiatives Manufacturing company experience Team motivation (leadership skill) Communication skills Process engineering Regulatory compliance management Operational budget management Organizational budget management Senior leadership Stakeholder management

Full Job Description 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 c

GMP, 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