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.
Position Overview:The purpose of the Packaging and Labelling Technical Service Leader role is to provide leadership and oversight for technical packaging, labelling and business processes between the Clinical Materials Delivery organization, Lilly Packaging Development, and Collaborative Partners to ensure optimal fulfilment of demand. In addition, the Technical Service Leader will be the change owner as the technical packaging resource and will assess the impact of change controls from manufacturing for tablet size changes, vial size changes, or repackaging solutions. The Clinical Materials Delivery organization produces custom-designed trial materials for the next generation of Lilly products and post-launch studies under full GMP regulations.
Responsibilities:Lead the technical packaging and labeling group operating closely with Collaborative Partners, Global Packaging, the Technology and Development (GPTD) group, the Clinical Trial Quality group, Commercial Technical Services and operations, FING Plant Planners and FING Material Coordinators.
- Ensure critical packaging requirements are identified and maintained to prevent potential product SISPQ issues for clinical supplies.
- Ensure material specifications are maintained as required, as well as DCMOR content.
- Review milestone and progress that the technical packaging and labeling group are executing
- Interface with other Lilly departments
Assist in developing and implementing the Global PD Packaging and Labeling outsourcing strategies and serve as a resource for technical advice for special projects as well as new packaging components.
Look for new technology, updated processes and/or innovations, and conducts return on investment analysis.
Coordinates change control and aids with project deployment and leadership
Technical reviewer for specifications for primary, secondary and tertiary packaging component specifications.
Create packaging presentations for new products in the pipeline that will be packaged for clinical supplies.
Basic Requirements:- Earned Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Engineering or related field / experience
- Minimum five years experience in pharmaceutical packaging, with solid understanding of GMP requirements, Global Quality standards, package engineering, product and component specifications or equivalent.
- Experience with root cause investigation
- Exemplary teamwork/interpersonal skills, including effective written and verbal communication among teams and stakeholders
- Ability to effectively use TrackWise
- Ability to manage multiple priorities and positively respond to change
- Ability to proactively identify problems and work toward a solution
Additional Preferences:- Experience supporting business operations in a regulated environment
- Experience using Veeva QMS change control technology
Other Information:- Shift: Monday - Friday, Some work outside of core hours may be required to support the portfolio
- Some travel required, potential for international travel
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$115,500 - $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.
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