- Lilly (Indianapolis, IN)
- …technical depth of understanding of unit operations, technical transfers and process validation strategy. This position requires comprehensive knowledge of ... pipeline assets into commercial scale facilities (internal or external) with successful process validation and product yield delivery. + Work closely with… more
- Novo Nordisk (Bloomington, IN)
- …Supervisor. Essential Functions + Perform or leading risk assessments + Execute continued process validation and annual product review reports + Support tech ... family medical leave + Free access to Novo Nordisk-marketed pharmaceutical products + Tuition Assistance + Life & Disability...transfers of new products + Support and review process and engineering validation work + Investigate… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Responsibilities** : The Global Process Owner for Change Control, as a leader within the Global Quality Systems ... business processes, implementation tools and associated IT systems. Additionally, the Global Process Owner will be expected to lead the Change Control Community of… more
- Lilly (Indianapolis, IN)
- …American contract manufacturers and alliance partners. This oversight covers the process steps of selection, pre- validation / validation , ongoing operations ... of CMs manufacturing, Device assembly and packaging, the batch disposition process and maintenance/improvements of their quality systems. + Evaluate issues,… more
- Lilly (Indianapolis, IN)
- …management, laboratory specifications and methods + Previous equipment qualification and process validation experience + Previous experience with SAP or ... oversight contract manufacturers and alliance partners. This oversight covers the process steps of selection, pre- validation / validation , ongoing operations,… more
- Novo Nordisk (Bloomington, IN)
- …well as regulatory agency inspections, compliance and regulatory support initiatives, and process validation activities. + Essential Functions + This role will ... 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
- Sumitomo Pharma (Indianapolis, IN)
- Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma ... signal management throughout product lifecycle including signal detection, signal validation , signal escalation, development of risk mitigation strategies and… more
- Novo Nordisk (Bloomington, IN)
- …as regulatory agency inspections, compliance and regulatory support initiatives, and process validation activities. Relationships Reports to: Director or above ... 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 (Lebanon, IN)
- …both for the initial start-up of the manufacturing areas as well as post Process Validation support. + Understand and support global implementation of quality ... and problem-solving capabilities. They will also work to continuously improve process performance by implementing new technologies and continually monitoring the… more
- Lilly (Lebanon, IN)
- …will therefore construct a new campus to manufacture Clinical Trial (CT) Active Pharmaceutical Ingredient (API). This new facility will meet the needs for a rapidly ... IT architecture solutions tailored to sophisticated business challenges within the pharmaceutical manufacturing domain. This role demands a deep technical expertise… more