Manager, Drug Product Development & Manufacturing; Remote

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Mfg Planning & Operations Professional Remote, Ann Arbor, MI, US

30+ days ago Requisition

Salary Range: $ To $ Annually

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 a comprehensive benefits package including a 401(k) matching plan and health insurance, and paid time off and holidays.

Position Title:
Manager, Drug Product Development and Manufacturing

The Manager, Drug Product Development and Manufacturing is a technical role that supports the development, technology transfer and manufacturing of device combination drug products at contract manufacturing organizations (CMOs). A key component of this technical role is supporting the manufacturing of commercial combination products as well as providing technical expertise for additional development and supply-chain expansion efforts. This is a remote, work from home position with approximately 25% travel.

Preferred

Location:

Remote – US

Essential Duties and Responsibilities*

• Support activities for commercial manufacturing of device combination drug products at CMOs, including technical review of drug product batch records, on-site “person-in-plant” technical oversight, and support of other manufacturing activities at CMOs as required.
• Collaborate within Tech Ops and internal project teams including Supply Chain, Quality Control, Quality Management, Regulatory Affairs, as required, for timely execution of combination product manufacturing activities.
• Provide engineering and technical knowledge to support injection moulding, valve actuator assemblies, metering mechanisms, dimensional tolerances and functional performance, spray pattern and aerodynamic particle size distribution (APSD).
• Maintain technical documentation of device history (DHF), process validation and commercial manufacturing, and support combination device regulatory filings.
• Collect, analyze, and summarize data for continuous process verification (CPV) and provide input into remediation plans for identified gaps.
• Support combination product / device-related technical activities, including coordination with device suppliers/partners on components, specifications, and technical issue resolution.
• Partner with Quality and Regulatory to help ensure device/combination-product documentation expectations are met (e.g., device master record/device history record inputs where applicable) and support inspection readiness.
• Ensure manufacturing changes and investigations consider combination-product requirements, including interface with design controls and risk management activities as applicable.
• Create and review technical documents, reports, updates and presentations for cross-functional teams and management.

* additional duties and responsibilities as assigned

Qualifications (Education & Experience)

• Bachelor’s degree in Pharmaceutical Sciences, Engineering, Chemistry or closely related field from an accredited college or university, with minimum 4 years of experience with development and commercialization of device combination drug products.
• Drug device combination product experience required, including familiarity with applicable device quality system requirements (e.g., 21 CFR Part 820/4 and ISO 13485) and risk management principles (e.g., ISO 14971) as applicable.
• Experience in a GMP device…