What are the responsibilities and job description for the Director, Supply Operations position at ESPERION THERAPEUTICS INC?
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: Director, Supply Operations
Preferred Location: Remote – US
Essential Duties and Responsibilities*
- Oversight of Supply Operations including but not limited to leading the team to manage planning of Regulatory Starting Materials, API, Drug Product, supplier management, packaging technology, global customs/logistics, and the Sales and Operations (S&OP) processes and activities.
- Acquires forecasts commercial and all other inventory consuming events. Ensure forecasts are timely, accurate and well communicated in the organization. Leads the Sales and Operations Planning (S&OP) process.
-
Direct the change management activities including:
- Manages the approval and implementation of new and changed product components
- Measures, analyze, and report key process metrics.
- Troubleshoots and problem solves as necessary.
- Product launches or product extensions.
-
Lead the strategic and 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 semi-finished and finished products. 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 monitor 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.
- 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.
- Establish quantitative metrics consistent with the company’s business objectives for leadership in product cost, quality and delivery.
- Supplier Management – working with key stakeholders (e.g. Partners, Quality, Technical Services, Finance) develop an appropriate program for Supplier Management of all activities.
-
Planning initiatives:
- Implement mechanisms to ensure the disciplined and effective use of ERP within Planning and integration with other Functional groups.
- Identify and implement supply chain opportunities to realize improvement in service and cost.
- Develop and present business cases for stakeholder approval.
- Effectively communicate and present the progress of initiatives and programs to stakeholders.
- Oversee availability of raw materials, drug substance and drug product manufacturing, packaging and inventory management, supply chain management and delivery processes.
- Accountable for product cost drivers, overall cost of ownership, risk management, compliance and ongoing cost improvement for all products.
- Ensure fulfillment of agreed manufacturing service for clinical and commercial supply.
- Drive and establish the drug substance and drug product specification setting process.
- Provide management with routine updates regarding the productivity and efficiency of operations.
- Oversee development of budgets for accountable departments and ensure expenditures are within budget.
- Manage personnel in all accountable departments with a focus on retention and development.
- Act as supply planning interface with current and potential corporate partners.
- additional duties and responsibilities as assigned
Qualifications (Education & Experience)
- B.S. in Business, Pharmacy, Engineering or Life Sciences and a minimum of 10 years of pharmaceutical industry experience in Supply Chain and/or Manufacturing related activities and 8 years of direct management experience; or equivalent education and experience.
- An MBA with CSCP, CPIM, Lean Six Sigma certifications are highly preferred.
- Demonstrated strengths in continuous improvement of supply chain processes
- MRP/ERP skills are required including at least one implementation of SAP, Oracle, etc., systems
- Experienced in supervising small teams or leading Project teams
- Proven leadership in developing new business processes and moving them to automated systems and implementation
- 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 managing diverse project activities with pharmaceutical 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 supply chain management 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%)
