- GRAIL (Indianapolis, IN)
- …Lab Operations, and other stakeholders to support regulatory strategy development, product validation, audits, promotional material review, on-market product ... key member of the Regulatory team, offering insights and solutions on corporate product portfolios and strategies. + Provide regulatory support for both new and… more
- Parexel (Indianapolis, IN)
- **Job Purpose:** The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials ... adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE… more
- Lilly (Indianapolis, IN)
- …partners + Develop and grow the technical ability to be consistent with Drug Product External Manufacturing (DPEM) business needs for the supportedPlatform ... + Established technical, quality, and internal networks. + Prior experience supporting drug product parenteral manufacturing. + A thorough understanding of cGMPs… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- **Job Summary** The Associate Director , Global Product Quality - Biologics is responsible for directing quality oversight of clinical and commercial products ... Activities supporting all phases of clinical development as well as Commercial Product (API, drug product , and final finished product ). + Transforms… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- **Job Summary** The Associate Director , Global Product Quality - GMP Process is responsible for enabling the optimization and harmonization of key GMP ... defines, maintains continuously improves critical quality system elements including ** Product Quality Complaints (PQC), Corrective and Preventive Actions (CAPA),… more
- Lilly (Indianapolis, IN)
- …who are determined to make life better for people around the world. ** Associate Director - Digital Engineering Platforms** **Position Brand Description:** Lilly ... many other digital platforms leveraged by engineers across Lilly Manufacturing. **Job Description:** Associate Director to lead and support the management of our… more
- Lilly (Indianapolis, IN)
- …who are determined to make life better for people around the world. ** Associate Director - Digital Engineering Solutions** **Organization Overview:** At Lilly, ... twins, computational modeling, edge/IoT, and analytics solutions. **Responsibilities:** The Associate Director - Digital Engineering Solutions position, within… more
- Lilly (Indianapolis, IN)
- …who are determined to make life better for people around the world. The Associate Director is responsible for developing publication strategies and plans. The ... Associate Director will draw upon information from...Provides publications expertise to other publication professionals and respective product project. + Analyzes and interprets new and updated… more
- Lilly (Indianapolis, IN)
- …capabilities around the world, and emphasizing emerging, innovative technologies in both Drug Product and Biotech platforms utilizing advanced data and process ... such as Global Facilities Delivery (GFD) and Global Quality. **Responsibilities:** The Associate Director - Global Process Automation & Control Engineering… more
- Lilly (Lebanon, IN)
- …a successful startup into GMP manufacturing operations._ **Position Description:** The Associate Director - Technical Services/Manufacturing Science (TSMS) is ... responsible for managing the activities of TSMS personnel. The Associate Director TSMS must balance coaching a...and other functions to deliver on technical objectives, specific product business plan, and quality objectives. In the project… more
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