Filling Operations Associate - Parenteral RAMP

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Organization Overview:

Lilly is starting up multiple new Parenteral assets (PAR) in manufacturing to increase our reach to patients. These assets will provide medicine for current and future products, and we need to improve the RAMP of these assets (Rapid Acceleration of Medicine to Patients).  The RAMP Filling Operations Associate works closely with the Filling PT in a Site to ensure successful start-up and ramp-up for new Parenteral Operations. 

He/She will implement the Operational readiness roadmap and will ensure the implementation of appropriate business processes, supporting the PT effectiveness.

He/She will implement and oversee all aspects of Operational readiness for the RAMP Team supporting a site during the transition from Project to routine production, working closely with the Site, RAMP/Acceleration Team, GPP and all the functions.

Responsibilities:

• Role model, drive habits and capability in process team that follow MSOE
• Identify and fix batch related challenges that might come from a missing or poorly designed process
• Create standard work documents, process maps, and other tools for right first-time execution and sustainability
• Consult on best practices with the processes for work orders, deviations, change controls, etc
• Support the Filling Process Team in Implement and oversight all the aspects of Operational readiness, including the shop floor readiness and help the site in implementing all the business support processes needed to routine production for a Parenteral area, from APS till ramp-up (approximately 9months after PV)
• Support the Site to build the right capabilities for the operations (shift and Process Teams)
• Support the ramp-up by having the right set of metrics, review line performances and address human errors occurred on shift
• Help the Site in the right prioritization during the start-up of Parenteral Operations
• Support the Site in removing obstacles working with other teams/functions (e.g., Project team, GPP, functions, etc.)
• Be point of contact for central functions and project for planning, alignment, best practice sharing, and escalation
• Be the liaison between the Site and RAMP/Acceleration team and other sites for the planning of support resource
• Participate in or drive initiatives or special projects
• Support continuous improvement culture, including cross functional elaboration of proposal/assessment.

Leadership Support:

• Propose and participate in ad hoc workshop with sites (e.g., After Action Review, lesson learned, ….)

• Responsible for developing communications between Site and RAMP Team as well as with the broader PPN sites/functions and central organization
• Work at the Site and Network to assure shared learnings from other sites (both sharing and replication).

Basic Requirements:

• Bachelor’s degree is required with demonstrated relevant experience in a GMP facility, preferably 3 - 5 years in pharma manufacturing.

Additional Skills/Preferences:

• Previous experience with Lilly M&Q operations
• Experience in Production, QC, QA, Technical Services, Engineering or Regulatory is desirable
• Knowledge of cGMP's
• Technical writing and written communication skills are a plus
• Six Sigma Green Belt or Black Belt certification.
• Proficiency with computer systems including Microsoft Office products
• Demonstrate strong oral and written communication and interpersonal skills
• Experience with being a mentor, coach and/or giving and receiving feedback.

Additional Information:

• Overtime may be required
• Travel of 30 - 50% may be required to support startup sites
• May be required to respond to operational issues outside of core business hours and days
• Applicant will work in various areas within the Parenteral Plant. Some allergens are present in the Parenteral Plant. Mobility requirements and exposure to allergens should be considered when applying for this position.

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.

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Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$64,500 - $140,800

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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