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 39,000 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. Were looking for people who are determined to make life better for people around the world.

Organization Overview:

For 140 years, Lilly has manufactured medicines that improve peoples lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always.

This position is responsible for developing, implementing, and maintaining the process data analysis and knowledge management strategy for the Lilly Branchburg Technical Services /Manufacturing Science (TS/MS) organization. Working collaboratively with Information & Data Systems professions, the qualified individual will be responsible for defining the user experience, leading data integration initiatives, and trending of information (Data Visualization) from multiple databases to support manufacturing processes, process monitoring, process validation, and technical investigations. Requires expertise with process data management and data visualization. Extensive database usage experience is essential. Knowledge of cell culture, purification and support systems is a plus.

Responsibilities:

* Leads and facilitates the definition and implementation of data analysis and knowledge management strategy for TS/MS at the Lilly Branchburg site.

* Integrates data availability within data integrity compliance framework. Focus on achieving a consistent approach to digital solutions that deliver on process knowledge & understanding, efficient and effective monitoring and driving productivity while maximizing compliance outcomes.

* Collaborates with the Manufacturing, Quality Control, Information & Data Systems, Quality Assurance, Regulatory, Validation, and Engineering departments to define a shared vision and design concept for site data exchange. This position will represent Branchburg in cross-site data sharing initiatives.

* Ensures that data platforms are in place to support the transfer of processes and process improvements from development to the production facilities and from one production facility to another.

* Collaborates with global and site functions responsible for global data repositories.

* Identifies opportunities to enhance process data systems and makes decisions that impact their implementation.

* Engages with the end user to develop tools to streamline data trending and analysis (Data Visualization).

* Integrates analytical data and in-process manufacturing data from multiple database sources for the purposes of process monitoring and continued process verification. Drives database solutions impacting results within the Branchburg site.

* Authors or coordinates user requirements documentation. Provides user guidance for the maintenance of the manufacturing in-process database and resolves problems as necessary.

* Provides data analysis SME support for complex data requests for critical investigations and process improvements.

* Maintains awareness in external trends.

* Leads large-scale projects with greater risk, resource/financial requirements, or complexity.

* Anticipates and resolves key technical problems.

* Understands and performs all job responsibilities in compliance with safety and regulatory expectations, as well as, cGMP.

Basic Qualifications:

* BS degree with a minimum of 7 10 years experience

* R, SAS, SQL or other query language

Additional Skills/Preferences:

* Excellent communication skills, both oral and written.

* Have prior understanding of cGMP and regulatory requirements.

* Ability to independently master assigned processes and to coordinate activities with internal and external partners.

* Lesser years of experience will be considered under extraordinary circumstances or where consistent high-level performance measures have been sustained.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively Lilly) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively Lilly) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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.