- TEKsystems (Indianapolis, IN)
- …those results. Paired with Lab Informatics product group. Everytihng from early drug discovery through manufacturing . This is around scaling and producing ... & consult during labvantage implementation(s) key to capture cross-functional manufacturing knowledge Lab Execution (Labvantage): -This is their QC...at the beginning of the drug process. We have a lot of different tools… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …provides specialized technical leadership and oversight for all downstream manufacturing processes for the company's biologics portfolio executed at CDMOs. ... and risk assessment. + Provide expert technical oversight of downstream manufacturing operations at CDMOs, including review of batch records, deviation… more
- Novo Nordisk (Bloomington, IN)
- …process improvement initiatives, changes, and overall performance of the Digital Factory within Drug Product - Secondary + Perform Manufacturing review of all ... model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized… more
- Lilly (Indianapolis, IN)
- …the world. We are seeking a strategic and experienced Senior Director of Drug Supply Chain Security Act (DSCSA) Compliance & Quality to lead our enterprise-wide ... systems and operational excellence. The Sr. Director - DSCSA Compliance & Manufacturing Logistics Quality Assurance, is a Quality professional with expertise in GMP… more
- Lilly (Indianapolis, IN)
- …+ Relevant experience in synthetic molecule drug substance and/or drug product development, commercialization, or manufacturing . + Demonstrated deep ... Key responsibilities: + Deep technical knowledge of synthetic molecule CMC drug development science(s). + Knowledge of global CMC regulatory requirements and… more
- Lilly (Indianapolis, IN)
- …transformative software based AI products across the entire Lilly value chain: drug discovery, research, manufacturing , go-to-market, and general knowledge work. ... that make life better for people around the world, like model driven drug discovery and connected clinical trials. We hire the best technology professionals from… more
- Lilly (Indianapolis, IN)
- …Review and approve complaint investigations associated with use, design, and manufacturing investigations for medical devices and drug /device combination ... complaint handling elements of the quality system for devices and drug /device combination products. **Responsibilities:** + Lead, mentor, coach and provide feedback… more
- Fujifilm (Indianapolis, IN)
- …in Advanced Therapies, Cell Therapies or Cell and Gene Therapy drug development and/or contract manufacturing /testing organization or a service/product ... place for you. From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site, we thrive on collaboration, creativity, and purpose. Whether your… more
- Lilly (Indianapolis, IN)
- …working relationships to ensure full cooperation; guides effective and efficient drug development, and ensures high-quality medical evaluation of safety data + ... collaboration with cross-functional partners for the following: + CMC development, manufacturing changes, CMC submissions and CMC regulatory requests, + Company… more
- GE Aerospace (Indianapolis, IN)
- …GE processes and procedures in the areas of engineering, supply chain quality, and manufacturing . This role is for Engineer in the shop (EIS) located at in ... + As the shop engineering representative, drive a high rigor into the manufacturing and design integration process and identify and drive manufacturing support… more