Assoc. Dir - Large Molecule External Manufacturing Technology, Network & Viral Lead

Job Description

Welcome to our team

We are looking for a Large Molecule (LM) drug substance leader who will be eligible for advanced projects, deep trouble shooting and innovation projects.The global External Manufacturing Technology Group is a fast-growing area of the manufacturing network tasked with ensuring reliable, safe and compliant manufacturing of drug substance and drug products. Specifically, we manage tech transfer projects from R&D and inline nodes, develop or continuously innovate processes, and manage commercial supply issues including trouble shooting, post approval changes and deviations.  The technical vertical External Manufacturing is the steward of the processes and is responsible for end to end project management of R&D and inline projects. Our Company’s Animal Health has both large and small molecule external networks and this opportunity is covering the Large Molecule drug substance as the primary focus.

Responsibilities Include:

• This new position is a pivotal role in the management of our LM drug substance portfolio in our global CMO (Contract Manufacturing Organizations) network, including responsibilities primarily in the commercial space supporting tech. As overall leader or technical leader you will be focusing on leveraging external suppliers for LM drug substance process transfer and/or development, scale up, full-scale production and commercial lifecycle management. You will be part of the External Manufacturing Technology Management Group and will be responsible for a portfolio of LM drug substance projects and/or supply nodes with a focus on in-line supply. The potential project types include sourcing, technical transfer, R&D, process improvement & innovation, and trouble shooting. The focus of this role is on network transfers for viral products.
• In addition, spot audits and sourcing support on behalf of other team members will be required at times.
• The role is global with a key focus on US and is a perfect fit for individuals with a strong drive for excellence and achieving tangible business results. Critical Skills include strategic thinking and proactive project management with business and technical acumen, verbal communication, and electronic communication.  The individual needs to be able to act independently and travel as needed.
• At the Associate Director level, a focus will be placed on the technical leadership during all aspects of drug substance sourcing, tech transfer, process development, commercialization, and subsequent lifecycle management.  Once a supplier is selected, the individual will then be fully responsible for end-to-end execution of the project as the leader of execution managing both the internal drug product customers and the external supplier during the technical transfer or process development.  Once the technical transfer, validation and regulatory approval for a sourcing project is completed and ready for assignment to in-line supply, leadership of our Company’s Animal Health Supplier Technical Management program will be expected.  In addition, each member of the technology team will contribute to generating innovation and systems improvements as appropriate.
• The individual will be expected to partner with our Network team, Global Procurement, other functions in Science & Technology (S&T), Quality Assurance (QA) and our internal site manufacturing network to complete network transfer, global sourcing & development projects. Here the individual will define the requested services including generating technical packages, lead technical due diligence for supplier selection, and verify that the aspects of supplier selection are considered appropriately, including assurance of supply, quality, service, cost and innovation.
• At all times, the individual must be adept at managing customer relationships, internal to the company and external suppliers.
• Supplier Technical Management will be conducted to ensure the on time and full delivery of drug substance to our Company’s Animal Health.  The individual will be expected to manage a defined set of suppliers and act as steward for select drug substances and:
  • Lead cross functional meetings with the external suppliers and company’s internal personnel to monitor the technical aspects of the relationship including tracking all changes, deviations, and improvement projects.
  • Lead the process change team inside of our Company’s Animal Health working closely with our internal or ext…