Associate Director, Tech Ops Project Management
Esperion is a purpose driven company with a singular focus on lipid management for everyone. Our innovative team of lipid management experts is committed to leveraging its understanding of cholesterol biosynthesis to develop innovative therapies for the treatment of patients with elevated low-density lipoprotein (LDL-C). At Esperion we are passionately committed to bringing complementary therapies to the hypercholesterolemia space that address unmet patient needs in a way that is “patient-friendly, physician-friendly and payer-friendly.”
Esperion’s corporate headquarters are 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: Associate Director, Tech Ops Project Management
The Associate Director, Tech Ops Project Management is responsible for the overall project portfolio and collaborating with Project Leaders in planning and tracking of cross-functional activities in CMC, supply management infrastructure, and other projects as assigned, with the focus on interactions leading to on-time delivery, successful supply implementation and commercialization readiness. The position reports into the VP of Manufacturing Planning and Operations. Available as a remote position from a home-based office.
Preferred Location: Remote – US
Essential Duties and Responsibilities*
- With Project Leaders, develop and maintain project management standard templates for timelines, cross functional dependencies, plans, and tracking to support Technical Operations, CMC and supply management infrastructure projects, such as ERP, business process change management, and other manufacturing operations implementations.
- Collaborate with specific key project working teams to ensure the project scope and plans are translated into CMC specific project timelines, milestones and key deliverables leading to commercial implementation.
- Develop an overall dashboard to track the project portfolio, timing of the availability of relevant CMC documentation, key CMC data, milestones, and decisions needed to support marketing applications.
- Support the tracking of CMC responses to HA questions received for relevant submissions.
- With Project Leaders, support team meetings to identify tasks and timing, prepare presentations and/or Gantt charts to show upcoming or overlapping activities. Facilitate resolving resource conflicts and management escalations, as needed.
- Prepare status reports and other appropriate documentation (dashboards, presentations, summaries, etc.) to support communication of status of CMC activities cross-functionally.
- Coordinate with Project Leaders to identify risks, resolving scheduling and budget issues related to the key projects.
- Evaluate and communicate the probability and impact of risks, coordinating the development of mitigation strategies.
- Clearly communicate project portfolio progress and collaborate with internal Project Leaders to ensure alignment with overall asset development, filing, and commercial plans.
Qualifications (Education & Experience)
- BS or advanced degree in Pharmaceutical Sciences, Chemical Engineering or related discipline from accredited college or university. Substantial direct experience in Technical Operations, CMC, and commercial supply projects will be considered in lieu of degree.
- Minimum 10 years’ experience in CMC plus minimum 5 years’ hands-on experience in Project Management involving CMC and commercial supply of brand pharmaceutical products.
- Demonstrated understanding of the drug development process including regulatory and quality requirements, in addition to post-approval commercial supply implementation.
- Demonstrated success in a team environment with strong project management.
- Excellent written and verbal English communication skills with proven ability to speak to groups of varying size and composition.
- Proven ability to partner with the business functions in order to enable high-quality outcomes.
- Excellent organization skills, demonstrated attention to detail, ability to manage multiple priorities and to meet deadlines in a fast-paced environment.
- Demonstrated experience and proficiency with MS Project, other project management tools and practices, as well as ERP and MS Office.
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