IDAP TS​/MS Representative

Location: Indianapolis

IDAP TS/MS Representative page is loaded## IDAP TS/MS Representative locations:
US, Indianapolis INtime type:
Full time posted on:
Posted Todayjob requisition :
R-99274

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 Brand

Description:

** The Technical Services and Manufacturing Sciences (TS/MS) Representative is a technical position that supports, develops and implements a technical agenda for their area of responsibility. The TS/MS Representative is responsible for providing technical leadership for activities within Indianapolis Device Assembly & Packaging (IDAP), including new product commercialization and commercial product support.  

Primary objective s include reliable and compliant manufacturing of products, continuous improvement of processes, and supporting day-to-day operations of process teams.
** Key Objectives / Deliverables:
*** Execute the overall technical agenda for the IDAP site.
* Provide technical support to non-routine (e.g., deviation, complaint) investigations, including consultation on quality and stability issues acting as product expert.
* Prepare, review, and approve, as required, relevant technical documents such as:  annual product reviews, change controls, regulatory submissions, deviations, validations, procedures, PFDs, PFMEAs, etc.
* Lead technical projects to improve process control and/or productivity.
* Drive technical consistency across process teams.
* Serve as interface with upstream suppliers, and global device / drug product networks.
* Own batch records and revisions, ensuring they are current and accurate.
* Facilitate equipment commissioning and qualification activities, as required
* Collaborate with Commercialization Project Manager as well as cross-functional tech transfer team members to commercialize new products in IDAP
* Understand the scientific principles required for Device Assembly and Packaging operations
* Support regulatory submissions as needed
* Understand and implement global requirements and standards into Process Teams.
* Own and maintain structure and content for electronic batch tickets.
* Monitor process control and capability.
* Provide off hours support as needed to process team
** Basic Requirements:
*** Bachelor’s degree or equivalent in a STEM discipline
* Technical / Scientific knowledge.
* Clear understanding of cGMPs.
** Additional Preferences:
*** Good written and oral communications.
* Good teamwork and interpersonal skills.
* Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.

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