Consumables Coordinator â Clinical Trials Pilot Plant, Bioprocess Operations
3 weeks ago
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. Weâre looking for people who are determined to make life better for people around the world.
The Clinical Trial (CT) manufacturing organization is responsible for the production of drug substance, supporting the BRD organization and their objectives. The facility is focused on new protein therapeutics to market by producing bulk drug substance (API) for clinical trials, along with the associated technical data and documentation to support GMP activities. The plant is located within Building 360 (K360) in Indianapolis, IN at the Lilly Technology Center North campus.
The Consumable Coordinator is responsible for the direction & oversight of consumable planning and buying. The role is responsible for developing &planning, ordering and maintaining inventory & risk management strategies for GMP consumables. The role is responsible for vendor relationships for key materials & partners with procurement as needed. The Consumable Coordinator provides technical leadership and oversight for consumable material qualification and specification. The position will also represent K360 on global consumable material strategy projects where they directly impact manufacturing sites.
Key Objectives and Deliverables:Â
Partners with the Manufacturing Plant Planner to understand schedule and priorities. Partners with tech service, and operations to under demand. Responsible for inventory management and consumable ordering. Â
Manages documentation and electronic records for qualifying new consumables, consumable Specification, and consumable suppliers, for consumables, and packaging materials used in B360 CT Operations.
Monitors component inventory levels at the B360 CT Operations site working with contract company to ensure inventories meet demand. Establishes and ensures completion of regular cycle counting and inventory reconciliation transactions.
Communicates with consumable suppliers and staff to understand and manage supply issues.
Oversight for ULS management of dock and consumable warehouse.
Active participant with the Supplier Change Notification (SCN) process, reviewing change notifications and ensuring material and/or supplier records are updated when applicable.
Authors/Reviews and follows procedures applicable to the business.
Utilize change management system to create, approve, execute, close changes and associated action items. Ensure changes are made in accordance with applicable standards.
Utilize deviation management system to create, document, lead and close investigations/deviations/action items.
Ensure a safe working environment by following safety rules and helping implement/improve the safety culture.
Participates in departmental site self-assessments and relevant audits.
Coach and mentor peers.
Must be knowledgeable on how to apply GMPs in a clinical trial environment.
 Demonstrate engagement and employ a quality mindset in all endeavors by proactively identifying quality issues and communicate appropriately.
Basic Requirements:
Minimum HS Diploma or GED, with a minimum of 4+ years of experience in GMP environment
OR
Bachelors in science, business or engineering or related field
Experience with the application of GMPs in a clinical trial and/or manufacturing environment(s)
Additional Preferences:
Exceptional organizational skills with attention to detail
GMP Manufacturing experience.
Experience with SAP and Ariba purchasing systems.
Experience with Microsoft Office (Excel / Word)
Familiarity with Power BI
Familiarity with Trackwise
Ability to work independently and handle multiple projects.
Ability to communicate and work effectively with Operations, Tech Services, Engineering and Quality groups.
Ability to use and apply multiple computer applications (Syncade)
High initiative, flexible and positive attitude
Ability to respond to changing priorities and short lead times.
Excellent verbal and written communications skills with the ability to interact well in a team environment.
Additional Information/Requirements:
Location: Indianapolis, IN
Monday through Friday Day Shift
Some work outside of core hours may be required to enable the delivery of the portfolio.
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively âLillyâ) 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.
Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Womenâs Network, Working and Living with Disabilities. Learn more about all of our groups.
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