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.

Job Description

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 35,000 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.

Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN. This facility is Lilly’s largest investment in manufacturing capacity and is intended to provide APIs for current and future products. This is a unique opportunity to be a part of the leadership team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations.

Job Overview

The TS/MS organization provides technical oversight to ensure robust and consistent biology and chemistry throughout all aspects of the manufacturing process. Through cross functional collaboration, TS/MS ensures the quality and safety of our products through process monitoring and knowledge to control, prevent and mitigate variability to deliver a reliable supply of medicine.

The Associate Director is primarily responsible to lead TS/MS scientists’ team on the technical oversight of the manufacturing process with the purpose of ensuring the reliable and compliant manufacturing of bulk drug substance. Additionally, this role partners with other roles within the TS/MS organization and other functional disciplines to support the functional and site objectives.

Responsibilities:

The successful candidate is responsible for:

• Ensuring that the team has a fully understanding of the protein chemistry, control strategy, and manufacturing platform related to the purification process of drug bulk substance.

• Prioritization and execution of routine process monitoring, manufacturing support and that processes remain in control and capable in accordance with regulatory requirements and cGMPs

• Development of technical capabilities within the technical staff and performance management

• Providing technical leadership for the preparation, review and approval of technical documents including investigations, change controls, manufacturing tickets, periodic product reviews, process validation and other technical documents.

• Acting as the primary technical representative in a cross-functional setting on Flow Team Meeting, Deviation Board, etc

• Leading the development and execution of process validation, process changes and implementation of technical agenda projects with the collaboration of the secondary loop and other functions.

Basic Qualifications

• Bachelor's Degree in scientific disciplines of Chemistry, Biochemistry, Microbiology, Protein Chemistry, Biophysical Chemistry, Bioanalytical Chemistry, or Bio/Chemical Engineering

• 5+ years of experience in any of the following disciplines such as Technical Services, Pharmaceutical Manufacturing, Protein Manufacturing, Quality Control, Quality Assurance, product and/or process development or Engineering

• 1+ year of supervisory experience in a relevant industry

Other Requirements

• Technical writing and presentation skills

• Excellent interpersonal skills that promote engagement and teamwork within cross-functional environment.

• Knowledge of cGMP, applicable global regulatory manufacturing guidance, and the process/cleaning validation in drug substance pharmaceutical manufacturing are a plus. Flexibility is required to support site needs in a 24/7 environment

• Teamwork oriented

• Demonstrated ability to learn and apply technical/scientific knowledge Ability to communicate and effectively influence across functional groups and stakeholders

• Technical leadership, administrative and organization skills

• Strong problem-solving skills

• Proficiency in delivering highly complex tasks and/or tasks that are highly cross-functional Strategic thinking and ability to balance short term needs with long term business goals

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 is an EEO/Affirmative Action Employer and 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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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