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

MSD•Rahway, NJ

6d•Hybrid

About The Position

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.

Requirements

Bachelor's degree in Biochemistry, Biochemical Engineering, Bioprocess Engineering or comparable
Minimum 10 years of relevant experience
Experience in development of viral vaccines and a wide array of LM drug substances (monoclonal antibodies, antigens for vaccines, antibody drug conjugates, m-RNA etc.)
Demonstrated high level of technical capability
A minimum of 5 years spent in LM process development roles
Strong business acumen
Communication skills
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 the Microsoft suite of applications and scheduling tools (Microsoft Project, Primavera etc.)
Biologics
Good Manufacturing Practices (GMP)
Manufacturing
Process Development (PD)
Product Transfers
Project Leadership
Project Management Leadership
Technical Transfer
Technology Transfer
Vaccine Manufacturing
Vaccine Production
Vendor Evaluations

Nice To Haves

PhD in Biochemistry, Biochemical Engineering, Bioprocess Engineering or comparable with a minimum 7 yrs. of relevant experience
Deep 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 projects in global CMOs
Experience in due diligence audits of CMOs
Working knowledge of Regulatory strategy and execution in EU and US (FDA and/or USDA)
Six Sigma and/or Project Management Professional (PMP) certification
Contract Manufacturing
External Manufacturing
Process Scale Up
Regulatory Strategies
Technical Project Leadership
Technical Project Management

Responsibilities

Manage the LM drug substance portfolio in our global CMO network, focusing on commercial space supporting tech.
Leverage external suppliers for LM drug substance process transfer and/or development, scale up, full-scale production and commercial lifecycle management.
Manage a portfolio of LM drug substance projects and/or supply nodes with a focus on in-line supply.
Lead technical due diligence for supplier selection, ensuring assurance of supply, quality, service, cost and innovation.
Manage customer relationships, both internal to the company and external suppliers.
Ensure on time and full delivery of drug substance.
Manage a defined set of suppliers and act as steward for select drug substances.
Lead cross functional meetings with external suppliers and internal personnel to monitor technical aspects of the relationship, including tracking changes, deviations, and improvement projects.
Lead the process change team, working closely with 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).
Guide process development at the supplier for R&D projects.
Leverage appropriate software systems 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 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 relevant governance forum meetings.
Assist communications with suppliers during troubleshooting or visit facilities to conduct due diligence.
Act as overall leader or technical leader for LM drug substance portfolio management.
Focus on network transfers for viral products.
Conduct spot audits and sourcing support on behalf of other team members.
Define requested services including generating technical packages.
Manage internal drug product customers and external suppliers during technical transfer or process development.
Lead the Supplier Technical Management program once technical transfer, validation, and regulatory approval are completed.
Contribute to generating innovation and systems improvements.
Partner with Network team, Global Procurement, other functions in Science & Technology (S&T), Quality Assurance (QA) and internal site manufacturing network to complete network transfer, global sourcing & development projects.