Associate Director, Large Molecule Exm Technology
Vor 6 Tagen
Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that is devoted to delivering a high-quality, reliable supply to customers and patients on time, every time.
We are looking for a Large Molecule (LM) drug substance leader (m/f/d) who will be eligible for advanced projects, deep trouble shooting and innovation projects.
Specifically, we manage tech transfer projects from R&D and inline nodes, develop or continuously innovate processes, and we manage supply issues including trouble shooting. 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. 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 in both the commercial and pre-approval space. As overall leader or technical leader you will be focusing on leveraging external suppliers for LM drug substance process 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.
Critical Skills include strategic thinking and proactive project management with business and technical acumen, verbal communication, and electronic communication. At the Associate Director level, a focus will be placed on the technical leadership during all aspects of drug substance sourcing, 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
Once the technical transfer, validation and regulatory approval for a sourcing project is completed and for assignments to in-line supply, leadership of the Companies Animal Health Supplier Technical Management program will be expected. The individual will be expected to partner with External Manufacturing & Global Procurement organization of Animal Health Manufacturing and the different Animal health functional departments to complete 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 the Animal HealthGroup. 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 the Animal Health Groupworking closely with our internal or external formulation facilities, regulatory, and quality to execute changes at the supplier.
Ensure appropriate knowledge management of drug substance technology.
Develop and pursue innovation projects with the supplier to improve process efficiency and reduce Cost of Goods (COGs)
For R&D projects guide process development at the supplier
Leverage appropriate software systems including for supplier communication and change control.
Provide strong leadership and business acumen for project management and lead cross-functional team members effectively.
Create overall project schedules with Microsoft Project including input from cross-functional partners (regulatory, formulation, supply chain, quality, procurement, R&D) and ensure they are appropriate for the project delivering end to end outcomes.
Present status updates via Microsoft Power Point in the relevant governance forum meetings
Bachelor's/Master’s degree in Biochemistry, Biochemical Engineering, Bioprocess Engineering or comparable
A strong business acumen, communication skills, and a proven track record of managing projects in the areas of sourcing, process development & commercialization, tech transfer, manufacturing process troubleshooting and supply of biotechnology products.
Ability to maintain strong working relationships with technical, quality and operations leaders in the internal and external network.
Ability to use Microsoft Project and the Microsoft suite of applications.
PhD in Biochemistry, Biochemical Engineering, Bioprocess Engineering or comparable with a minimum 7 yrs. Demonstrated track record of managing technical project in global CMOs.
Six Sigma and/or Project Management Professional (PMP) certification preferred.
Reporting Structure: This position reports to a Director of API Technology Portfolio Management as part of ExM Technology in Animal Health.
We offer an attractive salary, outstanding social benefits and an exciting work environment with varied tasks in an international environment.
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