Sr Principal - Site Molecule Steward

Eli Lilly and Company; Alzey; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A global healthcare leader in Alzey is seeking a Site Molecule Steward for Drug Product manufacturing. This role requires a bachelor's degree in science or engineering and at least 5 years of experience in parenteral product manufacturing. The Site Molecule Steward will provide technical leadership, manage projects, and ensure compliance with technical and regulatory guidance. This is a unique opportunity to contribute to the innovative new manufacturing site, focusing on high-tech environments and sustainability.

Qualifikationen

• Minimum of 5 years directly supporting parenteral product manufacturing.

Aufgaben

• Serve as technical subject matter expert for all topics related to drug product manufacturing.
• Provide technical direction on deviations and production challenges.
• Represent the TS/MS function in regulatory interactions when needed.
• Implement understanding of trends impacting the Alzey site.
• Communicate and transfer knowledge effectively.

Kenntnisse

Strong communication skills

Technical leadership

Ability to prioritize and multi-task

Ausbildung

Bachelor's degree in science or engineering

Jobbeschreibung

Overview

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing, and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 billion to create a new state-of-the-art manufacturing site at Alzey, Germany. The brand-new facility will use the latest technology to increase the company\'s manufacturing capacity in parenteral (injectable) medications, device assembly and packaging operations. This is an exciting once-in-a-lifetime opportunity to help build and operate a new site. The Lilly Alzey site will be built using the latest high-tech equipment, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact on our environment. This is an opportunity you don’t want to miss!

Position Description

• The mission of Technical Services/Manufacturing Sciences (TS/MS) is to provide scientific leadership and technical support for manufacturing to make medicine today and tomorrow.
• The Site Molecule Steward is the subject matter expert for the Alzey Site Drug Product manufacturing. The Site Molecule Steward will provide local technical leadership and expertise for projects involving TS/MS.
• The Site Molecule Steward will assume ownership of control strategy implementation and execution at the manufacturing site.
• The Site Molecule Steward will regularly interact with peers across the parenteral network, including TS/MS, QA, QC, Regulatory and Engineering, both site and central.
• The Site Molecule Steward for Drug Product should also routinely interact with their Drug Substance counterpart.
• The Site Molecule Steward should share learning and ensure strategies are in line with technical, quality, and regulatory guidance, while supporting business expectations.
• The Site Molecule Steward should bring a sense of curiosity broadly to product performance and other related investigations.
• The Site Molecule Steward will also play a critical role in technical capability building and coaching at the site to ensure capabilities are in place to meet business objectives.

Responsibilities

• Serve as technical subject matter expert for all topics related to drug product manufacturing.
• Provide technical direction on deviations, production challenges, and impact assessment of change controls.
• Represent the TS/MS function in regulatory interactions, as needed.
• Be responsible and influential with respect to implementation of external/corporate trends and understanding of how these changes could impact the Alzey site.
• Excellent technical writing and oral communication skills along with the ability to effectively communicate and transfer knowledge to all levels of the organization.
• Although not a supervisory role, technical leadership, and the ability to cross functionally influence are important in this role.

Requirements (Education, Experience, Training)

• Minimum of bachelor\'s degree in science or engineering field
• Minimum of 5 years directly supporting parenteral product manufacturing

Preferred Attributes

• Strong communication skills
• Capability to prioritize and multi-task effectively
• Collaborate with other functions as teams as appropriate

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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