IDAP TS/MS Representative
Posted 2 weeks ago
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Upload Your ResumeAbout This Role
The TS/MS Representative is a technical position that provides technical leadership for activities within Indianapolis Device Assembly & Packaging (IDAP), focusing on new product commercialization and commercial product support. This role supports the reliable and compliant manufacturing of products, continuous process improvement, and day-to-day operations.
Responsibilities
- Execute the overall technical agenda for the IDAP site.
- Provide technical support to non-routine investigations and act as a product expert on quality and stability issues.
- Prepare, review, and approve relevant technical documents like annual product reviews, change controls, and regulatory submissions.
- Lead technical projects to improve process control and productivity.
- Collaborate with Commercialization Project Managers and cross-functional teams to commercialize new products.
- Own and revise batch records, ensuring they are current and accurate.
- Facilitate equipment commissioning and qualification activities.
- Monitor process control and capability.
- Provide off-hours support to the process team as needed.
Requirements
- Bachelor’s degree or equivalent in a STEM discipline
- Technical / Scientific knowledge
- Clear understanding of cGMPs
Qualifications
- Bachelor's degree or equivalent in a STEM discipline
Nice to Have
- Good written and oral communications
- Good teamwork and interpersonal skills
Skills
* Required skills
Benefits
About BioSpace
Lilly is a global healthcare leader headquartered in Indianapolis, Indiana, specializing in discovering and bringing life-changing medicines to patients worldwide. They are investing over $1 billion to create a new state-of-the-art manufacturing site in Concord, NC, focusing on parenteral medication...