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: Manager, Planning
The Manager, Planning is responsible for API and Regulatory Starting Material (RSM) planning in support of manufacturing operations and commercial supply. This role is accountable for the availability of commercial API and RSMs; efficient scheduling of production at CMOs, detailed master production schedule/forecast allocation accuracy, and optimum inventory levels. Performs other tasks and projects in Planning as assigned. The Manager, Planning reports to the Director of Materials Management. This position is available as a remote, work from home opportunity.
Preferred Location: Remote – US
Essential Duties and Responsibilities*
- Lead the tactical supply chain activities including:
- Creates, monitors, and updates the Bills of Material.
- Develops and maintains Planning Assumptions in conjunction with Manufacturing Operations and Purchasing, including safety stocks, lead-times, order quantities, campaign strategy, batch yields, cycle times, etc.
- Develops, maintains, communicates, and monitors, the Production Plan and Schedule to meet and maintain targeted inventories of API and RSMs. Creates production planning options for management and financial review as necessary.
- Translates Production Plan to Materials Requirement Plan (MRP) for Bill of Material items and services.
- Creates purchase requisitions and monitors through approval process. Places purchase orders with suppliers. Monitors and expedites delivery process to ensure availability for production schedule. Monitors and expedites raw material release process to ensure availability for production schedule.
- Tracks all open purchase orders against invoicing and contract pricing.
- Interfaces with contract manufacturers, forecasts and orders CMO requirements, manages lot release and delivery.
- Maintains the corporate perpetual inventory file, ensuring that it is up-to-date and accurate. Performs monthly reconciliation of the corporate balances with site and CMO reported balances.
- Direct the change management activities including:
- CMO activities to support new product launches or product extensions.
- Manages the approval and implementation of new and changed product components.
- Troubleshoots and problem solves as necessary.
- Supports the Sales and Operations Planning (S&OP) process.
- Plan availability of RSMs and API through manufacturing and master production schedule management, supply chain management and delivery processes.
- Ensure fulfillment of agreed manufacturing services for clinical and commercial supply.
- Ensure the commercial API and RSM purchase specifications are established and met through commercial supply.
- Provide routine planning updates.
- Support development of budgets for accountable departments and ensure expenditures are within budget.
*additional duties and responsibilities as needed
Qualifications (Education & Experience)
- B.S. in Business, Pharmacy, Engineering or Life Sciences. An MBA and CSCP and CPIM certifications are highly preferred.
- Current role as Planner for API and RSMs, with a minimum of 5 years of supply planning and pharmaceutical industry experience in Supply Chain and/or Manufacturing related activities.
- MRP/ERP skills are required including at least one implementation of SAP, Oracle, etc., systems.
- Experienced in supervising small teams or working with CMOs/cross-functional teams.
- Ability to work/lead in a dynamic group that takes a multi-disciplined team approach to executing and achieving departmental and corporate goals.
- Excellent interpersonal and communication skills.
- Superior communication skills (both written and oral) are essential. Experience working in a multi-cultural, multi-lingual environment is necessary with a demonstrated ability to contribute successfully in a multi-disciplinary team environment.
- Must have hands on experience in handling diverse project activities with pharmaceutical API, RSM, or drug product manufacturing facilities at different geographical locations.
- Strong project management experience with cross-functional team leadership and participation skills.
- Demonstrated ability to successfully work with and influence contract manufacturing partners while maintaining a positive working relationship.
- Demonstrated strong working knowledge of planning is considered essential for the position. Competence in material management and forecast planning is required. Requires expert understandings of: formulation/drug product process development and scale-up; packaging, technology transfer; cGMPs, FDA, EU, ICH guidelines; as well as CMC content of regulatory submissions.
- Strong ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations.
- Demonstrated success in participating in pre-approval inspections by FDA and other regulatory agencies.
- Possess strong conflict management and negotiation skills.
- Excellent verbal and written communication skills.
- Self-motivated, able to work independently and be reliable and responsive.
- Specialized knowledge, Licenses, etc.: Demonstrated experience in the implementation of supply chains and quality systems in a commercial setting. Strong understanding and working knowledge of cGMPs for pharmaceutical development and commercial operations.
- Working conditions (ability to travel, lifting, etc.): Office environment with extensive international travel required (20 to 30%)
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