Assoc. Dir., Engineering

MSD

23h•Remote

About The Position

The API Technology & Portfolio Management group is the steward and owner of the science and technology and the associated processes for small molecule products in our company being manufactured by our external partners. The group is also responsible for the scale up and commercialization of new products. We practice excellence in the technical activities to support the sites including validation, qualification, engineering and maintenance. The group helps ensure a compliant, safe, environmentally conscious and reliable supply for research and in-line products by leveraging appropriate technology, innovating and improving our processes. We manage the portfolio of project execution, troubleshooting and technical knowledge.

Requirements

Technical and project management skills are critical.
Ph.D. Degree in Chemical Engineering or Chemistry or equivalent
Minimum 7 years of relevant experience in human or animal health working within a c.GMP environment
Extensive experience working with external suppliers.
Experience with process development and scale-up and or technical transfer and be familiar with chemical processes
Experience of working with highly regulated markets and examples of value added contributions to regulatory dossier submission and review
A strong business acumen, communication skills, and a proven track record of managing projects in the areas of sourcing/commercialization/tech transfer/chemistry process troubleshooting supply of API products
Strong Leadership attributes including a global mindset
Demonstrated ability to lead a cross-functional teams with an end to end supply chain view
Ability to collaborate across functions and geographies
Strong interpersonal skills
Ability to maintain strong working relationships with technical, quality and operations leaders in the internal and external network
Ability to use Microsoft Project 2010
Ability to communicate with Chinese and Indian suppliers and manage across time and space is required.

Nice To Haves

Understand the technical characterization of product physical properties and familiarity or expertise with chemistry and finishing crystallization
Expertise in troubleshooting and process improvement for chemical manufacturing for API
Six Sigma certification
Additional language capability

Responsibilities

Leveraging external suppliers for API development and full-scale production and the potential project types include sourcing, technical transfer, R&D, process improvement, and troubleshooting.
Operational excellence projects will be assigned as able.
Interfacing with the External Manufacturing & Global Procurement organization of our Animal Health Manufacturing Division and the different Animal health R&D departments to develop and manage the supply base and complete sourcing projects.
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.
Follow-up the quality and the timeliness of the delivered services
On Technical Transfer projects the individual will typically be the overall project lead and ensure the execution of the project is on time and in full.
Providing strong leadership and business acumen for project management and lead cross-functional team members effectively
Displaying leadership behaviors and demonstrate a high emotional intelligence
Creating and ensuring the overall technical transfer schedules including regulatory and formulation site inputs are appropriate for the project delivering end to end outcomes.
Working closely with external suppliers to assess the chemistry and processing equipment and limit risk on transfer
Evaluating material physical property and chemical comparability and mitigate risk
Conducting troubleshooting exercises and process improvements with the existing API suppliers.
Assist in communications with the suppliers and visit facilities to conduct due diligence and or resolve technical issues.