Quality Control Lab Informatics Lead

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 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.

**Company 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 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.

We’re looking for people who are determined to make life better for people around the world.

#WeAreLilly

**Organization Overview:**
Lilly is currently constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy.

At Lebanon, Indiana, this facility will be Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly.

It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance.

This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to design, commission, start up, and maintain the facility for both clinical and commercial supply.

This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up.

The Quality Control Laboratory assures patients worldwide receive safe and efficacious drug and drug/device combination products through effective execution of product testing.

**Responsibilities:**
The Laboratory Informatics role is responsible for monitoring laboratory performance to ensure that the QC laboratory maintains a state of control regarding the generation and reporting of analytical data.

Responsibilities will initially involve interacting with global and local IT support functions to populate master data, configure systems, and assist with installing and qualifying laboratory IT systems such as LIMS/LES (LabVantage, MODA), ELN (NuGenesis), and other lab systems (Empower, WinKQCL).

The role will evolve into monitoring, execution, maintenance, and continuous improvement of the Laboratory IT Systems for the QC lab with an emphasis on continuous improvement, especially with regard to data integrity.

This role will serve as a representative for laboratory IT systems and will be responsible for mentoring and educating peers on the use of lab systems, supporting audits, and oversight for management reviews, laboratory metrics, laboratory equipment, and laboratory documentation.

+ Performs and/or supports the laboratory with the validation of laboratory equipment and software systems
+ Supports the establishment and maintenance of the validated state of software-based computerized systems in use in the lab
+ Ensures data integrity by design within the QC laboratory
+ Leads site deployment and upgrade of QC laboratory IT systems such as MODA, Empower, NuGenesis, and LabVantage
+ Partners and builds relationships with Global Quality Laboratory Network, Global and Site IT team members
+ Acts as business owner and contact SME for QC laboratory IT systems
+ Collects data and authors management review documents for the laboratory quality system
+ Provides oversight and supports continuous improvement of quality systems as they relate to the QC lab
+ Applies knowledge of quality principles, cGMP, and laboratory systems towards the development and execution of local procedures, training courses, and practices
+ Assists in improvement of quality systems by creating or revising worksheets, developing or updating laboratory execution system documentation, updating laboratory methods, and maintaining other lab documentation systems
+ Manages and supports audit and inspection activities for the laboratory
+ Manages methods in the QC Laboratory
+ Performs and mentors others in change control, analytical investigations, root cause investigations, and activity planning
+ Implements and complies with corporate, site, and laboratory safety standards
+ Develops training materials

**Basic Requirements:**

+ Bachelor's degree in computer science, information systems, chemistry, microbiology, biology, or applicable related degree
+ 5+ years in QC pharmaceutical experience, including leading or working effectively with a cross-functional group

**Additional Skills/Preferences:**

+ Deep understanding of compliance requirements and regulatory expectations
+ Demonstrated accuracy and proficiency in analytical skills
+ Proficiency with computer systems including Microsoft Office products, LIMS, Laboratory Execution Systems, chromatography systems, electronic laboratory notebook systems including implementation of systems
+ Ability to work in a lab environment including wearing appropriate PPE and other safety related equipment or considerations
+ Excellent written and oral communication skills
+ Previous LEAN experience; ability to drive continuous improvement
+ Experience operating or implementing Lab IT systems including LIMS and Automated Lab Execution systems.
+ Strong technical aptitude and ability to train and mentor others
+ Project management experience
+ Demonstrated problem-solving and decision-making capability
+ Demonstrated technical writing skills
+ Proven cross-functional leadership utilizing problem-solving and decision-making skills

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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees.

Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities).

Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.

The anticipated wage for this position is

$65,250 - $169,400

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

#WeAreLilly

Required Skill Profession

Other General