Esperion - The Lipid Management CompanyVerified Employer
Business Services & Consulting • all cities, SD 42
Exec Director, Drug Substance Development & Manufacturing (42)
all cities, SD 42On-sitePosted 1 hour ago
Business Services & Consulting
About the Role
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
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
What You'll Do
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.
