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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.

For 140 years, Lilly has manufactured medicines that improve people’s 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.

DPEM TS/MS SME will be a member of the Technical Service Device Assembling and Packaging organization (DAP) is responsible for providing technical oversight and formal mentoring to primary loop TS/MS representatives for process, material, system and equipment associated with device assembling operations and/or secondary packaging of parenteral products, vials and devices.

This role is responsible for all technical activities related to the identification, selection, implementation, and maintenance of CM operations and on-going process improvements related to device assembling and/or packaging platform.

This role will participate on new resources hiring process with the Functional Sr. Director.

Key Objectives/Deliverables:

+ Support On-Going CM Operations by providing technical oversight

+ TS/MS Senior staff are responsible for driving CM technical excellence connected to DPEM lead team and central functions and interact with primary loop and members of DPEM.

+ They're expected to possess deep technical knowledge and understanding which allows them to assess process vulnerabilities and provide informed, science-based support to deliver the objectives. Including: Improve technical capabilities of the DPEM.

+ Provide mentoring and guidance on technical knowledge development to primary loop, assuring adequate knowledge management.

+ Support and/or own the most critical or complex deviations/complaints and provide a lesson learned transfer to the primary loop. Provide guidance and Lead (if required) product/process related Root Cause Analysis and provide product/process expertise in incident investigation and troubleshooting.

+ Support and/or Led Major Change Controls.

+ Definition and improvement of DAP control Strategy/PFD/PFMEA. Review periodically control strategy/PFD/PFMEA is still valid for the intended use. Ensure it is aligned with DAP Global Control Strategy/PFD/PFMEA.

+ Lead/coordinate regular technical reviews of processes, process optimization and variability reduction efforts as well as process and validation studies.

+ Review and approve technical/validation document including studies and reports. Assumes the role of the subject matter expert for key products/platform devices and/or packaging technologies and processes.

+ Coordinate and collaborate with resources (Joint Process Teams (JPTs), vendors) to identify opportunities and replicate improvements across the device’s/packaging´s lines installed in the different CMs and Lilly sites. Drive integration and alignment of different JPTs from the same platform, product, and process.

+ Integration with corresponding network/Platform and provide regular communication with Product and Process Steward

+ Lead technical agenda, working with CMs to develop and implement equipment upgrades and support technical studies.

+ Support audit/inspection preparation, observations answers and 3-day field alerts upon requirement.

+ Perform internal notification to management as necessary.

+ Assist Global Procurement on Due Diligence of prospective new partners as required. Assess new contract manufactures, particularly with regards technical capabilities, level of implementation of Lilly and GMP standards and recommended their suitability as a future partner.

+ Assess the technical capabilities of existing contractors to assemble and/or package additional products.

+ Support Start-Up and Implementation of CMs: Ensure the technical transfer of robust processes and establish appropriate critical process parameters and specifications and control strategy.

+ Support installation of equipment at CM operations, providing support to SAT and IQ/OQ/ PQ (if required).

+ Provide help and guidance, in conjunctions with QA on development of appropriate manufacturing and quality systems.

+ Design studies and provide data to support regulatory submission requirements.

+ Supervise manufacturing start up and validation to ensure success and review documentation and summary reports.

+ Initiate strong working relationship with Contract Manufacturers.

+ Effectively instruct/mentor others.

Basic Qualifications

+ Education:

+ Bachelor’s degree in Pharmacy, Engineering, or similarly related fields

+ Experience:

+ 8+ years’ experience in pharmaceutical manufacturing and/or technical services

+ Prior experience supporting device assembling and packaging products.

+ Skills:

+ A thorough understanding of cGMPs and drug product manufacturing.

Additional Skills/ Preferences

+ Project coordination or management skills include the ability to lead teams to produce quality deliverables within established timeframes.

+ Ability to represent Eli Lilly’s mission, policies, and practices in a positive, professional, and ethical manner and to influence CMs.

+ Knowledge and ability to apply basic statistical tools.

+ Equipment, utility, and facility qualification experience.

+ Good communication skills, especially attention to detail in written procedures and protocol development.

+ Strong leadership, interpersonal and teamwork skills.

+ Ability to lead and manage highly complex technical projects.

+ Use of data and science to support decisions, capable of making independent informed decisions.

+ Willingness to learn new technologies.

+ Capability to work in a virtual and complex environment.

+ Willingness to travel.

+ Appreciation for cultural diversity.

Additional Information

+ Travel is possible, up to 40 %.

+ **This role is onsite in Indianapolis, IN with the ability to work from home up to 4 days per month.**

+ **This role is not approved for remote or hybrid work**

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

$66,000 - $189,200

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.

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