- Lilly (Indianapolis, IN)
- …for the development and delivery of programs for continuous process optimization and improvement. **Key Objectives/Deliverables:** + Understand the scientific ... technical projects (experimental, modeling and/or production data analysis) to improve process control, yield, and/or productivity. + Provide technical support for… more
- Lilly (Indianapolis, IN)
- …+ The monitoring and control of the manufacturing environment. + Plant hygiene. + Process validation . + Training. + The approval and monitoring of suppliers of ... product testing; including Chemical and/or Micro tests for raw materials, in- process samples, semi-finished and finished products, physical and functional testing of… more
- Lilly (Indianapolis, IN)
- …detail-oriented Visual Inspection Subject Matter Expert (SME) specializing in parenteral pharmaceutical products. The SME will be responsible for overseeing and ... the internal and external manufacturing network. **Technical Expertise & Process Optimization** : + Serve as the go-to expert...Q standards, Common Q practices, ) and execution documents ( validation reports, PoDs ) to support the visual inspection… more
- Novo Nordisk (Bloomington, IN)
- …cleaning and sanitization, regulatory (worldwide), deviation investigation, product and process validation , environmental testing, and investigations, preferred. ... is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product… more
- Lilly (Indianapolis, IN)
- …the world. **Organization Overview:** Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization (API-EM) that delivers a ... and site management. The candidate will be responsible for process monitoring, response to issues, and improvements where necessary....state. + Understand, justify and document the state of validation with data that evaluate the capability of the… more
- Lilly (Indianapolis, IN)
- … pharmaceutical scientists, and engineers to deliver product and process insights for synthetic peptide and oligonucleotide programs. Engaging with scientists ... control strategies to enable clinical trial material delivery and build process understanding. **Responsibilities:** + Collaborate with project teams to develop… more
- Lilly (Indianapolis, IN)
- …their strong foundation in analytical sciences and experience in synthetic process or formulated product development to enable clinical trials, regulatory ... and engineers while offering access to world-class capabilities for pharmaceutical development. **Responsibilities:** + Develop analytical methods, justify specifications,… more
- Bristol Myers Squibb (Indianapolis, IN)
- …in Indianapolis. This role will conduct method development and method validation along with day-to-day activities to support commercialization of aseptically ... Support and perform testing for microbial test method development, qualification and validation for bioburden, sterility, and endotoxin testing + Support review and… more
- Lilly (Indianapolis, IN)
- …Oversee and support technical activities related to aseptic processing, including validation , deviation investigations, and process improvements. + Ensure ... internal audit activities. + Review and approve technical documentation, including validation protocols, reports, and quality records. + Drive continuous improvement… more
- Cardinal Health (Indianapolis, IN)
- …in- process , and product samples. + Executes method verification, validation , and/or transfer protocols, analytical equipment qualification protocols, or computer ... system validation test scripts, as needed. + Performs stability testing...21 CFR 210, 211 in the FDA regulated industry ( Pharmaceutical or Medical Device) preferred. + Has experience in… more