at Merck in Millsboro, Delaware, United States
Job Description
Job Description
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 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. Our company has both large and small molecule external networks and this opportunity is covering the Large Molecule drug substance as the primary focus.
Job Functions
+ 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.
+ Spot audits and sourcing support on behalf of other team members will be required at times.
+ The role is global 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, 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 for assignments to in-line supply, leadership of the company’s 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 External Manufacturing & Global Procurement organization of Manufacturing and the different 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 for our company. 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 internal or external formulation facilities, regulatory, and quality to execute changes at the supplier.
+ Follow up on deviations and ensure they are resolved quickly and appropriately.
+ 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.
Importantly, for all assignments the Associate Director must:
+ Provide strong leadership and business acumen for project management and lead cross-functional team members effectively.
+ Display our company’s leadership behaviors and demonstrate a high emotional intelligence.
+ 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.
+ Work closely with external suppliers to proactively develop or assess the manufacturing process, evaluate processing equipment, and limit risks during scale up, transfer or process changes.
+ Present status updates via Microsoft Power Point in the relevant governance forum meetings
+ As required, the individual will assist communications with the suppliers during trouble shooting or visit facilities to conduct due diligence.
Minimum Education Requirement and Experience:
+ Bachelor of Science Degree in Biochemistry, Biochemical Engineering, Bioprocess Engineering or comparable with ten (10) years of experience in development of a wide array of LM drug substances (monoclonal antibodies, antigens for vaccines, antibody drug conjugates, m-RNA etc.) and a demonstrated high level of technical capability. OR
+ Master of Science Degree in Biochemistry, Biochemical Engineering, Bioprocess Engineering or comparable with eight (8) years of experience in development of a wide array of LM drug substances (monoclonal antibodies, antigens for vaccines, antibody drug conjugates, m-RNA etc.) and a demonstrated high level of technical capability.
Required Experience or Skills:
+ A minimum of 4 years spent in LM process development roles.
+ 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.
+ Strong Leadership attributes including a global mindset.
+ Demonstrated ability to lead cross-functional teams with an end-to-end supply chain view.
+ Ability to collaborate across functions and geographies and support global activities.
+ Strong interpersonal and communication skills
+ 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.
+ Travel: 15 to 30%
Preferred Experience and Skills:
+ PhD in Biochemistry, Biochemical Engineering, Bioprocess Engineering or comparable with a minimum 7 yrs. of relevant experience.
+ Understanding and experience in process scale up for LM drug substances.
+ Expertise in trouble shooting of upstream and downstream operations.
+ Demonstrated track record of managing technical project in global CMOs.
+ Experience in due diligence audits of CMOs.
+ Working knowledge of Regulatory strategy and execution in EU and US (FDA or USDA).
+ Six Sigma and/or Project Management Professional (PMP) certification preferred.
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