EEM-API is the hub for the management of Elanco external manufacturers of active pharmaceutical ingredients. The API Operations Manager plays a critical role in the support of the API portfolio and is responsible for the performance of contract manufacturers. The API Operations Manager has complete responsibility for all aspects of API manufacturing and supply. This includes executing appropriate governance for these CMs and suppliers, ensuring that appropriate levels of service and compliance are met.
- Responsible for working closely with functional leadership in the definition of contract terms and negotiation strategies.
- Represent EEM-API by assisting procurement with the negotiation of new contract manufacturing contractual arrangements and renewals.
- Provide on-going oversight for ensuring site compliance to contractual arrangements. Team member during due diligence and site selection.
- Responsible for monitoring and influencing all functional activities associated with product supply from the CMs; driving collaboration between functional areas (e.g. Planning/Scheduling, CMC, QC, QA TS/MS of finished products and R&D) to resolve issues and ensuring reliable product supply and product quality in a cost effective manner. Governance will include oversight of a balanced scorecard including but not limited to requirements of the Global Contract Manufacturing Standard’s (GCMS).
- Responsible for change control management in compliance with Elanco quality system.
- Indirect leadership with CM product teams. Indirect leadership of approximately 10 employees who support external manufacturing operations.
- Responsible for forming, facilitating and leading the appropriate governance structure in accordance with GCMS’s, including the establishment of steering teams, joint process teams, project teams, setting relationship goals and success indicators, driving continuous improvement activities and overall monitoring of performance.
- Responsible for completing periodic reviews of CM relationships against set goals and objectives; recalibrating expectations as appropriate.
- Conducting periodic risk assessments of CMs and communication of results to senior management.
- Responsible for improving work practices, quality and reducing costs.
- The role may be required to participate in CM selection and due diligence activities as required. These activities will be driven by global business development and the requirement for new product launches.
- Responsible for the adherence to appropriate financial, quality, supply chain, HS, regulatory internal standards as well as internationally recognized standards at the external manufacturers.
- Responsible for supporting successful technical transfers either into or from contract manufacturers. Ensuring that supply remains undisrupted throughout any technical transfers or terminations.
- Engineering or Science degree (B.S. or higher)
- 5+ years experience in a cGMP or related environment
- Strong skills in organic and analytical chemistry
- Ability to influence others to obtain business results
- Demonstrated learning agility
- High communication skills
- Excellent mentoring and coaching skills
- Ability to prioritize multiple activities
- Understanding VICH standards and post approval change guidelines applied in the manufacture of API’s
- Previous successful supervisory experience
- Proficiency with applications like SAP, TrackWise, etc.
- Understanding of supply chain methodology – operational supply chain excellence concepts
- Knowledge of Global Contract Manufacturing Standards
- Reports to: Senior Director– Elanco External Manufacturing of Active Pharmaceutical Ingredients
- Direct reports: none
- Travel: approximately 20 – 25%